Yourlawyer.com (Duragesic Patch News)

Warning on Transdermal Patches, MRIs

Fri, 06 Mar 2009 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) has just issued information regarding the use of transdermal patches when undergoing MRI testing. The medicated patches, which are applied to the skin and that contain aluminum or other metals in the backing of the patches, can contain metal which can overheat during an MRI scan and which can cause skin burns in the immediate area of the patch.

The patches are meant to slowly deliver medication transdermally, or through the skin. But, some transdermal patches contain metal in the layer of the patch—generally the backing—that is not in contact with the skin and is not always visible. The labeling for most of the medicated patches that contain metal in the backing provides a warning to patients about the risk of burns if the patch is not removed before an MRI scan; however, not all transdermal patches that contain metal contain these warning labels, said the FDA.

The FDA is currently in the process of reviewing the labeling and composition of all such medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan.

Until the agency’s review is complete, it recommends that healthcare professionals referring patients for an MRI scan identify those patients who are wearing a patch before the scan conducted and to advise those patients about how to remove and dispose of the patch before undergoing the MRI scan, and how to replace the patch following the scan.

The FDA suggests that MRI facilities follow published safe practice recommendations concerning patients who are wearing patches (Kanal, et. al, “ACR Guidance Document for Safe MR Practices: 2007,” AJR 2007; 188:1–27 and Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009) and, until the safety issue is resolved, recommends the following for patients who use any type of medicated patch, including nicotine patches:

Advise the referring physician that you are using a patch and for what use the patch has been prescribed, such as for pain, smoking cessation, or hormone therapy, for example.
Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
Tell the MRI facility—at the time you make your appointment and when you provide answers to health history questions—that you are using a patch.

The FDA is also urging health care professionals and patients to report possible cases of skin burns while wearing patches during an MRI to the FDA through its MedWatch program. MedWatch can be reached by telephone toll-free at 1-800-FDA-1088 or via the Internet at http://www.fda.gov/medwatch/index.html.

Misleading Risperdal, Duragesic Patch Claims Prompt Fines in West Virginia Lawsuit

Wed, 04 Mar 2009 00:00:00 -0800

Risperdal maker Johnson & Johnson has been ordered by a West Virginia judge to pay a hefty fine over a 2003 letter to doctors that obfuscated the antipsychotic drug's diabetes risk. According to Bloomberg News, the same judge also assessed a smaller fine after finding that doctors were misled about the risks and benefits of the company's Duragesic pain patch.

Risperdal is one of class of drugs called atypical antipsychotics. Other atypical antipsychotics include Eli Lilly's Zyprexa, and AstraZeneca's Seroquel. These drugs have long been linked to an increased risk of weight gain and diabetes. According to Bloomberg News, in 2003, the Food & Drug Administration (FDA) required the makers of antipsychotics to warn about this risk.

The State of West Virginia had brought suit against Johnson & Johnson and its Janssen unit over claims made in the 2003 letter to doctors, Bloomberg News said. The FDA had already cited the same letter for being misleading. West Virginia Circuit Court Judge Martin Gaughan agreed, writing that the letter was "deliberately constructed to circumvent the FDA's mandated warning for an increased risk of diabetes, and deliberately constructed to mislead health-care professionals."

According to Bloomberg News, the judge fined Johnson & Johnson $1.95 million for the letter and an additional $2 million for Risperdal sales calls made in West Virginia from November 2003 to July 2004.

The makers of antipsychotics have faced increasing scrutiny over the way these drugs are marketed. Hundreds of lawsuits have been filed by individuals who claim the drug's diabetes risks were hidden. Meanwhile, federal and state authorities have, like West Virginia, filed lawsuits over the drugs' illegal promotion.

Earlier this year, Eli Lilly agreed to pay $1.4 billion in fines to settle federal charges over its promotion of Zyprexa. Documents unsealed in Seroquel litigation indicate that, among other things, AstraZeneca directed sales reps to downplay the drug's diabetes risks.

In West Virginia, Judge Gaughan also assessed Johnson & Johnson and Janssen a $525,000 fine for distributing a brochure that contained misleading information about the Duragesic patch. According to a report on WOWKTV.com, the FDA had also warned the companies that the brochure was misleading.

In his order, Judge Gaughan wrote that "The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however . . . the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.”

Fentanyl patches, like the Duragesic Patch, have long been linked to accidental overdoses. In December 2007, FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

FDA Reviewing Narcotic Painkillers

Tue, 10 Feb 2009 00:00:00 -0800

The makers of two dozen opioid drugs, including Oxycontin, morphine, methadone and the Duragesic patch, have been ordered by the Food & Drug Administration (FDA) to develop Risk Evaluation and Mitigation Strategy (REMS) plans to reduce the misuse of their painkillers. The FDA's latest action on these narcotic painkillers comes just days after the agency and the Centers for Disease Control (CDC) announced that they will be working together to look at the rising trend of accidental opioid overdoses.

According to an article on USNews.com, the FDA sent letters to 16 pharmaceutical companies that manufacture the two dozen narcotic painkillers that will be subject to the new review. Drugs like the Duragesic fentanyl patch and Oxycontin are prescribed to treat chronic pain from cancer and other ailments. According to the FDA, approximately 21 million prescriptions for 3.7 million patients were issued in 2007 for these medications. A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

In a press release, the FDA said that drug manufacturers have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA said it believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

The FDA has scheduled a meeting with drug makers for March 3. After that meeting, the agency will work on putting new regulations in place for the painkillers. USNews.com said the FDA expects the process to last for several months. The new regulations could encompass additional warning labels, physician instructional materials, and stricter prescription indications, the report said.

Yesterday, we reported that the FDA and CDC had announced that they would be providing grants for research aimed at finding strategies to combat accidental painkiller overdoses. According to the agencies, accidental overdose deaths from narcotics or hallucinogens in the 15-64 years age range rose 5,921 in 1999 to 10,829 in 2005, an 83 percent increase. Unintentional overdoses not resulting in fatality saw a 44 percent increase from 376,611 to 542,372 accidents in the same time frame and within the same age group. Opioids painkillers were the prevailing factor in all the incidences.

According to the FDA, overdoses can occur if patients do not know how to take the drugs or if doctors drugs in a way that is not appropriate. Other overdose deaths occur when legitimate prescriptions get into the hands of people other than the intended patient.

Alert for Duragesic, Other Fentanyl Pain Patches Issued by Health Canada

Thu, 08 Jan 2009 00:00:00 -0800

Health Canada has announced that the makers of Fentanyl Transdermal System patches are changing dosage guidelines in order to reduce the risk of fentanyl overdoses. The products involved in this alert include Duragesic patches made by Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, as well as generic versions made by Cobalt Pharmaceuticals Inc., Novopharm Limited, Ranbaxy Pharmaceuticals Canada Inc. and ratiopharm inc.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

Health Canada has reminded health care providers that Fentanyl Transdermal Systems (patches) are only intended for use in patients who require continuous around-the-clock pain relief with strong narcotic pain relievers for an extended period of time and who are already taking narcotic pain relievers at a total daily dose of at least 60 mg/day Morphine Equivalents. The agency also said that the starting dosage of Fentanyl Transdermal Systems must be calculated using new conversion tables, and must not be higher than that dose which is comparable to the total dose of the narcotic drug the patient is receiving before they are switched to the fentanyl patch.

Health Canada also said that patients using Fentanyl Transdermal Systems should be advised to seek emergency medical help immediately if they:

have trouble breathing, or have slow or shallow breathing
have a slow heartbeat
have severe sleepiness
have cold, clammy skin
feel faint, dizzy, confused, or cannot think, walk, or talk normally
have a seizure
have hallucinations

Fentanyl patches have long been linked to accidental overdoses. Just last week, we reported that Ortho-McNeil-Janssen had recalled one lot of Duragesic 50 mcg/hr patches because of a defect that could cause fentanyl overdose. The recall also included one lot of Sandoz Inc. 50 mcg/hr patches.

Last February, the company also recalled 32 million Duragesic Pain Patches for a similar defect. At the time, it was estimated that about two out of every million patches could be defective.

In December 2007, the U.S. Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

More Duragesic Pain Patches Recalled

Fri, 02 Jan 2009 00:00:00 -0800

Once again, Johnson & Johnson is recalling some Duragesic Pain Patches because of a defect that could cause patients to overdose on fentanyl. This is the second time in less than a year that Johnson & Johnson has recalled Duragesic patches. A similar action was issued by the company just last February.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

The most recent Johnson & Johnson patch recall involves one lot of Duragesic 50 mcg/hr patches under the lot number 0817239 sold by PriCara. The recall also includes one lot Sandoz Inc. 50 mcg/hr patches under the lot number 0816851.

PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson. ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. A press release issued by PriCara said that other strengths of the patches, including 12.5, 25, 75 and 100 mcg/hr, are not affected.

In the press release, the company said it had identified a condition in manufacturing equipment that resulted in a cut-system defect in a small number of affected patches in the lots being recalled. The defect could result in a release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal, the release said.

PriCara is advising that anyone who has any of the recalled fentanyl patches should check the box or foil pouch to see if they have patches from the recalled lots. Cut patches should not be handled directly. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only. Soap, alcohol, lotions, oils or other products to remove the medicine gel should not be used because they may increase the medicine's ability to go through the skin.

Patches with cut edges should be disposed of by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief, PriCara said.

Last February, Johnson & Johnson recalled another 32 million Duragesic Pain Patches for a similar defect. At the time, the company estimated that about two out of every million patches could be defective.

In December 2007, the FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with products like the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.

Jury Rules Duragesic Pain Patch Killed Woman

Wed, 19 Nov 2008 00:00:00 -0800

The makers of the Duragesic Pain Patch have been held liable for the death of an Illinois woman. According to the Associated Press, a jury has ordered Johnson & Johnson subsidiaries, Janssen Pharmaceutica Inc. and ALZA Corp, to pay the woman's family $16.6 million.

Fentanyl-containing Duragesic Pain Patches and similar products are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

Over the past several years, problems with Duragesic patches have resulted in several recalls. Last February, about 32 million Duragesic Pain Patches were recalled because of concerns that they could be defective. According to the recall notice, there was a chance that some 25-microgram-per-hour patches might have had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. It was estimated that the defect could have affected 2 out of every one million patches.

In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.

According to the Associated Press, 38-year-old Jerry DiCosolo died in 2004 while using a Duragesic Pain Patch to treat pain she suffered as a result of a neurological problem. The lawsuit filed by DiCosolo's family claimed that Janssen and ALZA knew about problems with the Duragesic patch that allowed it to leak fentanyl in doses large enough to kill patients.

According to Bloomberg.com, this is the fourth Duragesic case that Johnson & Johnson has lost in the past two years. Last month, a Florida jury awarded more than $13 million to the family of a 34-year-old woman who died after using a Duragesic patch in 2002. Bloomberg.com also reports that in July 2006, a state court jury in Houston ordered Janssen and ALZA in July to pay $772,500 to the family of a Texas woman who died after her patch leaked.

Johnson & Johnson also agreed to pay the family of a Florida man $2.5 million in 2007 to resolve claims that he died as a result of a defective Duragesic patch, Bloomberg.com said. That settlement was reached after a jury had awarded the victims family $5.5 million at trial a month early.

Watson Recalls Fentanyl Pain Patches Over Leakage Worries

Tue, 12 Aug 2008 00:00:00 -0700

Fentanyl pain patches are being recalled by Watson Pharmaceuticals because some of them may leak fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

Watson's is recalling its 75mcg/hr fentanyl transdermal system patches sold in the US from wholesalers and pharmacies. The fentanyl transdermal system CII is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

The recalled fentanyl patches are from lot number 92461850, and have expiration dates of August 31, 2009 . The affected lot of fentanyl transdermal system patches was shipped to customers between January 30, 2008 and March 19, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall. The company said that it has notified the Food & Drug Administration (FDA) of the recall.

According to Watson, a small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No injuries have been reported in connection with the recalled lot.

Recalls of fentanyl pain patches are not unusual. Earlier this year, Johnson & Johnson recalled its 25mcg/hr Duragesic Pain Patches made by its Alza Corp. unit. All of the recalled Duragesic patches had expiration dates on or before December 2009. The recall was issued because defective Duragesic patches could have had sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking.

In December, the FDA issued an alert warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

Actavis Recalls More Fentanyl Pain Patches

Mon, 03 Mar 2008 00:00:00 -0800

More Fentanyl Pain Patches have been recalled by Actavis Inc due to a possible defect that could cause fentanyl to leak from the Actavis pain patches. Actavis had recalled 14 lots of the Fentanyl Pain Patches in mid-February. Actavis said the remaining lots of the fentanyl transdermal system patches are being recalled as a precautionary measure because the company lacks insurance that all patches are free from defects

Fentanyl transdermal patches are indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and that cannot be managed by other means. The first Actavis Fentanyl Pain Patch recall followed a decision by Johnson & Johnson to recall its 25-microgram-per-hour Duragesic Pain Patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. The defective Duragesic patches had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

On February 17, Actavis recalled 14 lots of its Fentanyl Pain Patch as a "precaution". Now Actavis is recalling remaining lots of its Fentanyl Pain Patch. All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States. The lots covered by this recall have expiration dates between May 2009 and December 2009. Anyone who has fentanyl patches labeled with an Abrika or Actavis label should check them for these expiration dates. Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be labeled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

Anyone with Actavis Fentanyl transdermal system patches with the lot numbers listed on the schedule, should call 1 877 422 7452.

Another Fentanyl Pain Patch Recall

Mon, 18 Feb 2008 00:00:00 -0800

Another fentanyl pain patch has been recalled today, amid concerns that such pain patches put users at risk of accidental fentanyl overdose. Today’s fentanyl pain patch recall was issued by Activis Inc., which is recalling 14 lots of its Fentanyl transdermal system CII patches sold in the United States by its subsidiary Actavis South Atlantic LLC from wholesalers and pharmacies as a precaution. The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl transdermal patches are indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and that cannot be managed by other means. This is the second fentanyl pain patch recall issued in less than a week. Last Tuesday, Johnson & Johnson recalled its 25-microgram-per-hour Duragesic Pain Patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. The defective Duragesic patches had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

According to the Food & Drug Administration (FDA), the 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal. The fentanyl pain patch lots covered by the Actavis recall include: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

According to the FDA, Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the recalled fentanyl pain patches are labeled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-08.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-08.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-08.

The FDA has warned that the affected patches should not be handled directly. Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1- 877-422-7452. Patients using fentanyl patches who have medical questions should contact their health-care providers.

Duregesic Patch Recall Adds to Johnson & Johnson Patch Woes

Wed, 13 Feb 2008 00:00:00 -0800

The Duragesic Pain Patch has been recalled by Johnson & Johnson because defects in the manufacture of the patch could lead to accidental overdoses. Johnson & Johnson is recalling about 32 million of the fentanyl-containing Duragesic Pain Patches, and the company estimates that about two out of every million patches could be defective.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

Today's Duragesic Patch recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J's PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. All of the recalled Duragesic patches have expiration dates on or before December 2009. The defective Duragesic patches have a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

The Duragesic Pain Patch has been a problematic device ever since it first came on the market. In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch "misuse" and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.

Jerry Parker, Managing Partner at Parker Waichman Alonso, LLP, said today's recall was not surprising considering Johnson & Johnson's track record with medicated patches. "Both the Duragesic and the Ortho Evra Birth Control Patch have caused serious injuries to users because of defects that allow the patches to deliver far more medication than is safe," Parker said. "This recall just points to the continuing problems Johnson & Johnson is having with its patch technology." Parker's law firm is currently representing plaintiffs who were injured by Johnson & Johnson's Duragesic and Ortho Evra patches.

The Johnson & Johnson Ortho Evra Birth Control patch was the subject of an FDA warning only last month after a study linked Ortho Evra to the development of a potentially dangerous type of blood clot. That warning was the FDA's second Ortho Evra blood clot warning issued since it was introduced to the market in 2002. In 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism - as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

Duragesic Pain Patch, Other Fentanyl Pain Patches Still Killing People, FDA Warns

Fri, 21 Dec 2007 00:00:00 -0800

The Duragesic patch and other generic fentanyl pain patches are still killing people, the Food & Drug Administration (FDA) warned today. The Duragesic pain patch, marketed by Johnson & Johnson, and other generic pain patches, emit the powerful narcotic painkiller fentanyl. These transdermal pain patches were approved to treat pain in people who use narcotics, such as cancer patients. Today’s FDA notice is the second time since 2005 that the agency has warned of fatal consequences linked to fentanyl painkilling patch misuse.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose. The Duragesic and similar patches use so-called “transdermal” technology developed by California-based Alza Corporation.

In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. That advisory emphasized the appropriate and safe use of fentanyl painkilling patches. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches.

Since the original 2005 health alert, the FDA has received further reports of deaths related to Duragesic and generic fentanyl pain patches, although the agency declined to reveal how many additional reports it has been received. As was the case in 2005, the FDA says that many of the deaths are related to fentanyl patch misuse. The FDA found cases where doctors wrongly prescribed it for headaches or post-surgical pain. But the FDA says patients also are accidentally overdosing by using the patches wrong, such as putting on more than prescribed, replacing them too frequently or getting them too hot.

Today, the FDA announced that it had ordered fentanyl patch makers to create special "medication guides" for patients that spell out the dangers of overdoses and improper use in easy-to-understand language. Among the many warnings to be contained in the new medication guides is the caution that fentanyl patches can cause trouble breathing, which can be fatal. Patients will be instructed to get emergency help if they have trouble breathing or extreme drowsiness with slowed breathing; feel faint, dizzy, confused; or have other unusual symptoms. These symptoms can be signs that a patient was prescribed too high a dose or took too much. The FDA is also warning that fentanyl patches are only for round-the-clock pain that is moderate to severe and expected to last for weeks. They are not for sudden, occasional or mild pain or pain after surgery.

Johnson & Johnson Settles Duragesic Patch Wrongful Death Lawsuit for $2.5 Million

Mon, 30 Jul 2007 00:00:00 -0700

Johnson & Johnson has agreed to settle wrongful death claims involving its Duragesic pain-killing patch for more than $2.5 million, according to Bloomberg.com. The settlement, paid to the family of a Florida man who overdosed on the opiod painkiller fentanyl while wearing the patch in 2003, was the first awarded by Johnson & Johnson in a case involving the Duragesic patch. Hundreds more wrongful death suits are still in the works.

“The settlement indicates that Johnson & Johnson realizes the seriousness of these cases and that they have to pay serious money to resolve them,” Alex MacDonald, a lawyer based in Boston, told Bloomberg.com. MacDonald has four cases involving Duragesic overdoses set to go to trial next year, while as many as 300 to 400 more similar suits have been filed, according to Bloomberg.

Johnson & Johnson may now have to consider an all-inclusive settlement for the many pending wrongful death suits, as it has lost both cases that have gone to trial. A jury awarded $772,500 in damages in a suit involving a Texas woman overdosed when her Duragesic patch leaked fentanyl onto her skin instead of administering it in a controlled dose. That case is still under appeal, Bloomberg.com reported.

In July 2005, the federal Food and Drug Administration (FDA) issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. Mylan Pharmaceuticals, a manufacturer based in Morgantown, West Virginia, has sold a fentanyl transdermal patch since it received FDA approval in January 2005. The results of the FDA probe are still pending. The agency is “continuing to investigate the safety of these patches to assure they remain safe and effective,'' FDA spokeswoman Kimberley Rawlings told Bloomberg.

The Duragesic painkilling patch, which disperses fentanyl directly through the skin, uses so-called “transdermal” technology developed by California-based Alza Corporation. Janssen Pharmaceutica, the defendant named in the recently settled Florida suit, marketed the Duragesic patch in the United States, but does not currently have the product listed on its Web site. Both Alza and Janssen are part of the Johnson & Johnson “family of companies.”

The jury in the Florida case found that officials employed by Johnson & Johnson were aware of the defects in the Duragesic product, but neglected to inform doctors and consumers about the potential risks. Jurors awarded $5.5 million to the family of Adam Hendelson in June, and Johnson & Johnson agreed to drop its appeal of the case as part of the settlement.

In 2004, the (FDA) recalled all 75 mch/h Duragesic patches, the line of the product that dispenses 75 micrograms of medicine per hour. That recall has since been expanded to include four more versions of the Duragesic patch. Recalled patches could potentially leak fentanyl if their edges are not properly sealed, leading to an excess of the prescription painkiller, a medicine stronger than morphine, and being absorbed into the body.

Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused, according to the FDA’s Web site.

Daughter wins patch case

Sat, 08 Jul 2006 00:00:00 -0700

A jury in Houston on Friday awarded $772,500 to the daughter of a Rosenberg woman who died after using a drug patch made by Johnson & Johnson.

The lawsuit stemmed from the death of Michaelynn Thompson, on Feb. 13, 2004.

The jury, which deliberated for seven hours, found that there was a manufacturing defect that caused the patch to leak, said, a lawyer for the family. He said the leak greatly increased the dose of the painkiller Thompson received. Trammell also said the jury found that Johnson & Johnson's Alza subsidiary was negligent in the way it made its Duragesic patch.

The jury did not award punitive damages in the trial, the first of its kind. There are about 100 more lawsuits involving the Duragesic patch, estimated another lawyer for the Thompson family.

The company said it disagrees with the outcome of the wrongful-death trial, in which 11 out of 12 jurors decided the Duragesic patch Thompson wore was defective. The patch is marketed and distributed by Janssen Pharmaceutica, another Johnson & Johnson unit.

The New Brunswick, N.J.-based pharmaceutical firm is evaluating its "legal options," Alza spokesman Mark Wolfe said Friday.

"We are confident in the safety of Duragesic and the benefits it provides patients with chronic pain," he said, declining to comment further.

Michael Zellers, who argued Johnson & Johnson's case in Houston, declined to comment.

Defense lawyers had claimed that because Thompson weighed more than 300 pounds she likely died of a heart attack.

The family attorney said Alza had recalled some of its patches a few days after Thompson died saying that if the patches leaked, patients could experience an uncontrolled release of fentanyl that could threaten lives. Fentanyl is a commonly used anesthetic that in high doses can turn off the respiratory center in the brain.

Fibich said that, under recent tort-reform law, the jury's verdict had to be unanimous for it to award punitive damages.

The lack of punitive damages disappointed Thompson's 16-year-old daughter, Kenzey Thompson, who lives with relatives in Santa Fe.

"I feel the company should be punished for what they've done," she said.

Testimony at the trial revealed that the year in which the recalled patches were made, Alza had quadrupled production because the patent was about to expire, said the plantiff's lawyer.

In 2003, Johnson & Johnson made $1.6 billion from Duragesic patches, about $430 million more than it made from selling the same product the previous year, Trammell said.

The Food and Drug Administration found that between January 2003 and June 2004, Alza made 40 lots of the pain patches, which are designed to deliver controlled, hourly doses, said the plantiff's attorney. He said the FDA received complaints of leaks in 35 of the 40 lots.

"The jury followed the evidence and came up with a true, good verdict in this case," said the plantiff's attorney.

A doctor who treated Thompson the day she died called her family a few days later, after he learned about a recall of Duragesic patches.

The Thompson family would "never have known the role of the drug fentanyl played in Ms. Thompson's death if they hadn't contacted us," Trammell said, noting that his firm collected blood from the medical examiner and had it tested.

The private-lab test showed the level of fentanyl in her blood was about 10 times what it would have normally been for pain-killing, Trammel said.

After the trial, Kenzey Thompson said she will use the $772,500 to pay for college and that she's considering law school.

Painkiller patch abuse blamed for deaths

Thu, 15 Jun 2006 00:00:00 -0700

Justin Knox bit down on the bitter-tasting patch, instantly releasing three days' worth of a drug more powerful than morphine. He was dead before he even got to the hospital.

The 22-year-old construction worker and addict was another victim in an apparent surge in U.S. overdoses blamed on abuse of the fentanyl patch, a prescription-only product that is intended for cancer patients and others with chronic pain and is designed to dispense the medicine slowly through the skin.

"I cannot tell you the amount of people I've seen and the creative ways they abuse this drug," said Dr. Scott Teitelbaum, director of the Florida Recovery Center in Gainesville, Fla. "Fentanyl has been abused for years. But recently there has been an increase. I've seen more chewing, squeezing of the drug off the patch and shooting it up."

Fentanyl, a synthetic narcotic, was introduced in the 1960s, but it was not until the early 1990s that it became available in patch form. Last year, the first generic versions of the patch hit the market.

At least seven deaths in Indiana and four in South Carolina since 2005 have been blamed on abuse of the fentanyl patch, along with more than 100 deaths in Florida in 2004. About a week after Knox's death in Farmington, Mo., in March, a second man in the same county was prescribed the patch legally and died after injecting himself with the gel that he had scraped from it.

Emergency-room visits by people misusing fentanyl shot up nearly 14-fold to 8,000 nationwide between 2000 and 2004, according to the U.S. Department of Health and Human Services. The figures do not indicate how many of those ER visits were because of the patch.

(In recent months, more than 100 deaths have been reported from Chicago and Detroit to Philadelphia among drug addicts who overdosed on heroin mixed with fentanyl. And federal drug agents believe fentanyl is being made in clandestine labs in Mexico and elsewhere.)

The first fentanyl patch was Duragesic, made by Johnson & Johnson. Sales more than tripled from 2000 to 2004. Worldwide sales were more than $2 billion in 2004, and half of that was in the U.S., according to the J&J's Web site.

More than 5.7 million prescriptions were written in 2003 for the Duragesic patch, according to IMS Health.

Mark Wolfe, spokesman for PriCari, the J&J unit that oversees Duragesic, said the product comes with strong "black box" warnings about the dangers of abusing Duragesic.

One theory is that addicts are turning to the fentanyl patch because of a government crackdown on abuse of another powerful prescription painkiller, OxyContin, or oxycodone.

"The abuse of oxycodone and the fear of litigation is enough to scare doctors from prescribing it. Duragesic is in vogue, as we've seen over the last year and a half and two years," said Dr. John Brandt, a chronic-pain specialist at the University of Florida.

In Missouri, the man accused of illegally selling the fentanyl patch to Knox has been charged with murder.

"The awareness is just not out there. I had never heard of this patch," said Knox's mother, Rose Marler. "There's a new generation of drugs and people just need to be aware."

Transdermal Patches: An Innovative Drug Delivery System That Has Raised Serious Safety Concerns

Mon, 06 Mar 2006 00:00:00 -0800

Until recently, drugs were administered in three basic ways; orally, intravenously, and by injection. At home, patients were limited to oral medications except for those who were trained to inject themselves with insulin.

As drugs have become more sophisticated in terms of their applications and extended-release capabilities, it has become necessary to devise methods by which patients can administer these new medications.

Drug delivery systems are now one of hottest areas of pharmaceutical research and development. It is estimated that U.S. demand for drug delivery systems will grow 9% annually through 2007.

Controlled-release pills are expected to remain as the dominant form while implants, patches, syringes, and inhalers are gaining rapidly. While it is anticipated that respiratory, central nervous system, and cardiovascular agents will stay as the top uses, hormones, anticancer agents, and vaccines are expanding.

The U.S. drug delivery system is now a $54 billion industry. It comprises an ever-growing list of delivery platforms including; controlled-release tablets and capsules, chewable tablets, infusion/IV products, prefilled syringes, hypodermic needles, monoclonal antibodies, liposomes, inhalers, transdermal patches, and implants.

The following summary can be found at: http://www.marketresearch.com/map/prod/891760.html

There are oral delivery systems including:

Oral Controlled-Release
Coated-Bead
Diffusion
Reservoir
Chewable Tablets
Rapid Disintegration
Buccal
Effervescent
Polymer-Based

Parenteral drug delivery systems include:

Infusion devices
IV Administration Sets
IV Pumps & Controllers
IV Catheters
Premixed IV Solutions
Hypodermic Products
Prefilled Syringes
Hypodermic Syringes
Hypodermic Needles
Gene/Protein Delivery Systems
Hemodialysis
Peritoneal Dialysis
Enteral Feeding Products

There are inhalation delivery systems including:

Dosage Formulations
Metered Dose Inhalers
Dry Powder Inhalers
Nasal Spray Dispensers
Ventilators
Nebulizers

Transdermal and implantable systems include:

Transdermal Drug Delivery Systems
Implantable Drug Delivery Systems
Pulse Generators
Drug Inserts
Drug-Eluting Stents

End-Use applications include:

Respiratory Agents
Central Nervous System Agents
Cardiovascular Agents
Digestive & Genito-Urinary Agents
Hormones & Related Agents
Anti-Cancer Agents
Anti-Infective Agents
Vitamins & Related Preparations
Biologicals

The evolution of nanotechnology has expanded the drug-delivery-industry even further. Nano-enabled drug delivery systems are expected to be extended to compounds used in treating both infectious disease and cancer.

Six types of drug delivery systems in which nanotechnology is likely to have a significant impact include:

injectable drugs: nanotechnology promises to create new dosage forms that are easier to administer, more pleasant for the patient, and more competitive in the marketplace.
implantable delivery systems often preferable to the use of injectable drugs since injectables often display initial blood concentration that goes up rapidly (then may fall exponentially) thereby causing potential difficulties with toxicity, and diminished efficacy as the drug concentration falls below the targeted range.
oral drug delivery systems remain preferable (to patients) to implantables or injectables. Thus, development continues with respect to traditional oral delivery systems with nanoengineered improvements.
(rapid) topical delivery of active compounds. Given their very small size, nanoparticles are able to enter human tissues and cells quickly.
transdermal systems: Since the number of FDA-approved polymers available for use on skin is increasing rapidly, new opportunities are presented to create new designs with improved ‘on-skin’ properties and diffusion of active molecules compared to current transdermal patches.
toxin removal. Colloidal dispersions have been demonstrated to remove potentially lethal compounds from the bloodstream, including high concentrations of lipophilic therapeutics, illegal drugs, and chemical and biological agents.

All of these rapidly developing delivery systems have potential down-side risks, however. Their newness and potential unpredictability in any given application has lead some experts to suggest more caution be exercised in approving and monitoring any new delivery system even if it is being used to administer an already approved medication.

One particular delivery system, transdermal patches, has raised concern since several medications utilizing this method of administration have been linked to a number of serious adverse reactions.

The reasons for the problems being encountered are diverse. Absorption levels and rates, patient abuse, environmental factors, and other variables have made transdermal patches the subject of any number of scientific articles, FDA investigations, lawsuits, and even a bizarre criminal prosecution (discussed below).

The following is an up-to-date collection of the newsworthy stories involving a number of the more controversial transdermal patches and the medications that are currently associated with them.

ORTHO EVRA BIRTH-CONTROL PATCH

The FDA has acknowledged the finding of a new study that indicates women using the Ortho Evra birth-control patch have an elevated risk of developing blood clots.

Notwithstanding the fact that this is far from the first evidence linking this potentially fatal side-effect to the “patch,” the FDA has taken the position that the results are only preliminary and do not require immediate action other than to advise women to discuss this risk with their doctors.

According to Dr. Daniel Shames, who is director of the division of reproductive and urological drug products at the FDA, preliminary findings from a study by i3 Drug Safety found women using the patch had twice the risk of developing blood clots compared to women taking birth-control pills.

In November 2005, after years of debate over the safety of the Ortho Evra birth-control patch, the drug’s manufacturer Ortho-McNeil (a subsidiary of Johnson & Johnson the world’s 4th largest drugmaker) finally acknowledged the fact that women who use the product are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.

Ortho-McNeil has now admitted that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

Critics of both the ‘patch’ and the FDA’s approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety. There has been a constant chorus of warnings about the extremely serious side-effects associated with the patch from a number of experts as well as the consumer watchdog group, Public Citizen (www.worstpills.org) and the Associated Press.

Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch.

CBS News also presented a significant story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.

According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.

In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.

Finally, the evidence indicated, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.

An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request.

The Associated Press follow-up story is even more damning, however. In that article, the AP stated: “Documents released to attorneys as a result of that litigation show Ortho McNeil have been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”

The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).

In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive.

Public citizen first listed some third-generation oral contraceptives as “DO NOT USE” drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills. Thus, elevated blood levels of progestin as well as estrogen are possible with the Patch.

The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from 2004.

Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.

The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA’s Web site at: http://www.fda.gov/cder/foi/nda/2001/021-180_ORTHO.htm.

Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote:

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the group” [emphasis in the original].

The FDA medical officer also included the following statement in his comments:

The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”

In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds (90 kilograms).

The professional product label warns that Ortho-Evra should not be used in the following circumstances:

A history of heart attack or stroke
Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
A history of blood clots in the deep veins of your legs
Chest pain (angina pectoris)
Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal
Contraceptives such as ORTHO EVRA, NORPLANT [levonorgestrel], or the birth control pill
Liver tumor (benign or cancerous)
Known or suspected pregnancy
Severe high blood pressure
Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
Headaches with neurological symptoms
Use of oral contraceptives (birth control pills)
Disease of heart valves with complications
Need for a prolonged period of bed rest following major surgery
An allergic reaction to any of the components of Ortho Evra
Women who may be using Ortho Evra should contact their physician if any of the following warning signals develop:
Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
Pain in the calf (indicating a possible clot in the leg)
Crushing chest pain or tightness in the chest (indicating a possible heart attack)
Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
Sudden partial or complete loss of vision (indicating a possible clot in the eye)
Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care professional to show you how to examine your breasts)
Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor) Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)

Since contraceptives are usually prescribed to young, healthy women they should be associated with the lowest possible risk of serious adverse drug reactions.

Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed).

There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills. As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); “Rarely do randomized pre-approval studies, the scientific ‘gold standard’ for proving safety or efficacy, present such strong evidence of a serious problem.”

As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.”

When reading the November 2005 Ortho-McNeil’s Press Release, the first thing that becomes obvious is that the company made a concerted effort to present the information in a way that was difficult (if not impossible) for anyone but an expert to understand.

For example, the acronym AUC is used without definition thereby making the references to estrogen concentrations difficult to extrapolate. AUC, however, is a measure of how much of a drug reaches the bloodstream in a set period of time, usually 24 hours. AUC is calculated by plotting drug blood concentration at various times during a 24-hour or longer period and then measuring the area under the curve between 0 and 24 hours.

When the implications of AUC are considered with respect to the amount of estrogen that can be released in a given period of time, the result is shocking since that amount can easily exceed 50 mg which is well beyond the level already determined to be unsafe.

A previous study conducted with respect to another contraceptive product (the “vaginal ring”) documented these excessively high levels of estrogen associated with the patch almost a year ago in the journal Contraception.

In addition to the risks already discussed cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including Ortho Evra, should not smoke.

Finally, litigation involving Ortho Evra has been gaining momentum in recent months and especially in light of the Associated Press investigation. The litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug.

A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea.

The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25-year- old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch.

The youngest woman to die, as reported in a recent study, had been an 18-year-old college student who collapsed in the New York subway. Ten other women ranging in age from 18 to 27 have also sued Ortho-McNeil.

In mid-November, however, another high-profile wrongful death case was commenced against Ortho-McNeil and Johnson & Johnson. It involves Alycia Brown, an eighth-grader in La Crosse, Wisconsin, who died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.

The federal law suit filed in Madison by her parents claims the patch was the cause of their daughter’s tragic death. The La Crosse County medical examiner has found that Ortho Evra was a likely contributing factor in Alycia’s death.

Although many lawsuits have already been commenced against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch, the 14-year-old is now the youngest known victim.

In September 2005, Parker & Waichman, a major New York based plaintiffs’ personal injury law firm that is heavily involved in pharmaceutical litigation announced that it had filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. The suit was filed U.S. District Court for the District of New Jersey.

According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch.

This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003.

Ortho-McNeil has routinely denied the allegations that these deaths and injuries were the result of Ortho Evra risk factors. It claimed that the “unsolicited reports” it received were not reliable evidence of a problem with the drug.

The company also claimed its own investigation had not found any causal factor linking these deaths to Ortho Evra and relied on the absence of any reports of fatal adverse side-effects during the clinical trials as proof of the drug’s safety.

Ortho-McNeil’s reluctance to accept even the possibility that the patch could be at fault has lead to the drug being kept on the market without adequate warnings. Even the company’s press release and FDA advisory regarding new labeling requirements do not satisfy the patch’s many critics.

In the eyes of those critics, the fact that Ortho-McNeil notified the FDA that it has undertaken a “much larger study” with respect to the potential problem of blood clots, strokes, and death associated with the patch merely prolongs the time in which millions of women are exposed to an unacceptable risk of catastrophic injuries and death.

In addition to the rather cryptic press release issued by Ortho-McNeil in November 2005 concerning the serious risks associated with its Ortho Evra birth control patch, the FDA published its own information for consumers wishing to learn more about those potentially fatal side-effects (http://www.fda.gov/bbs/topics/news/2005/NEW01262.html) as well as a series of questions and answers.

(http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm)

Some of the more telling remarks in the FDA material follow:

“FDA is announcing a revision to the label for the drug Ortho Evra. This change includes a new bolded warning about higher exposure to estrogen. Higher levels of estrogen may put some women at increased risk for getting blood clots.”

“A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks.”
“In general, a woman may be at higher risk for getting side effects if she takes higher doses of estrogen. Women should discuss with their health care professional whether the Ortho Evra patch is a good method of contraception for them.”

Following the November 2005 Ortho-McNeil Press Release and FDA Advisory, there have been several reports of doctors and other healthcare providers curtailing or even suspending the prescribing of the patch.

The Wall Street Journal (WSJ) reported that: “Many doctors have stopped writing prescriptions for a popular form of birth control after the Food and Drug Administration warned earlier this month of increased hormone exposure to women who use it.”

(http://online.wsj.com/article/0,,SB113262165542103693,00.html?mod=djemHL).

According to the WSJ: “[A] number of individual practitioners and major health-care providers say they don't want to take any chances. In Memphis, Tenn., obstetrician and gynecologist Henry Sullivant says he has stopped writing new patch prescriptions and suggests that his roughly two dozen patch users try other forms of prescription contraceptives, such as the pill or a monthly vaginal ring. Pennsylvania State University, which provides health services for 42,000 students, is no longer issuing prescriptions and says it is considering whether to contact all students who have been given prescriptions for Ortho Evra, even if they are no longer at the university.”

In a effort to exercise caution, similar actions are being taken by many other university health officials including those at the University of Texas at Austin, Stanford University, the University of California, Berkeley, and Connecticut College in New London, Connecticut where one patch user experienced a blood clot in her lung last spring.

In addition “Lee Shulman, incoming board chairman of the Association of Reproductive Health Professionals, says he expects that ‘there will be a decrease in use’ of Ortho Evra, at least over the next several months. He adds that he has been inundated with doctor and patient phone calls asking whether the patch is safe to use.”

A number of litigation attorneys we spoke with, who are familiar with pharmaceutical litigation, agreed that it is becoming more difficult for doctors and major healthcare providers like colleges and universities to ignore the mounting evidence and warnings and simply write thousands of prescriptions for the patch. The percentages indicate that when that many prescriptions are written some of the women will suffer serious or fatal adverse reactions.

There are also many well-publicized law suits alleging deaths and catastrophic injuries from the very side-effects contained in the November 2005 warning. Thus, any doctor writing a prescription for the patch from that point on is doing so at his or her peril. Given the potentially fatal side-effects of the drug, writing a prescription now could be considered irresponsible in terms of good and accepted medical practice especially if an otherwise healthy woman is paralyzed or dies from a stroke caused by blood clots after using the patch.

Thus, it is not surprising that so many healthcare providers are rethinking their policies and recommending alternative medications to their patients. The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).

As Lorie Brown, Alycia’s grieving mother, told reporters: "I'm out to let people know: get off (Ortho Evra). That's my biggest goal here. I didn't save her life, but maybe I can save somebody else's." It seems that many responsible doctors and major healthcare providers are trying to do the very thing.

Many experts, consumer watchdog groups, and critics of the FDA drug approval process in general, and Ortho Evra in particular, believe the dangers presented by the patch should have been obvious to the FDA before the drugs approval. They are also concerned by the FDA’s position that it intends to do nothing at present because it considers the information regarding the risks posed by Ortho Evra merely “preliminary.”

NICOTINE REPLACEMENT THERAPY

One of the most popular NRTs (nicotine replacement therapies) is the nicotine transdermal patch. The patch was first marketed in the U.S. by prescription only in 1992. By 1996 it could be purchased OTC (over-the-counter). Available brands include Habitrol, NicoDerm CQ, and Nicotrol.

The patch comes in several different strengths and is applied once a day in the morning. It is supposed to be removed just before going to bed. Wearing the nicotine patch to bed can disrupt sleep and cause vivid dreams.

A patient should not change brands without consulting a doctor and should not attempt to adjust dosages by cutting a patch in pieces. If the patch does not work in 4 to 10 weeks, it is unlikely that the patch will be successful.

Patients are cautioned to never use 2 patches at once. Patches should not be removed from their wrappers until ready for use and should never be stored at temperatures higher than 86 degrees Fahrenheit.

Side effects cannot be anticipated with respect to this patch. Thus, users are cautioned to monitor their reactions and to consult a doctor immediately if any occur or change in degree.

Common side-effects include; dizziness, high blood pressure, itching and burning at the application site, nausea, redness of the skin. Less common, but more serious side-effects may include; abnormal dreaming, allergic reactions, back pain, chest pain, constipation, cough, diarrhea, drowsiness, dry mouth, headache, impaired concentration, indigestion, inflammation of sinuses, menstrual irregularities, numbness, pain, pins and needles sensation, rash, sleeplessness, sore throat, stomach pain, sweating, taste changes, tingling, vomiting, and weakness.

NRT patches should not be used by people who are sensitive to or have ever had an allergic reaction to nicotine. Also, users are cautioned to monitor their condition if they have ever had a bad reaction to a different brand of nicotine patch or to adhesive tape or other adhesive material.
Patch users are warned not to smoke, chew, or sniff any form of tobacco while wearing a patch since doing so can produce a nicotine overdose. Moreover, for several hours after a patch is removed, nicotine is still in a user’s skin and passing into the bloodstream. Thus, users should not smoke even when the patch is removed.

Users are also warned that nicotine patches may aggravate certain medical conditions. Before you use any brand of nicotine patch, make sure your doctor knows if you have, or have ever had, any of the following conditions:

Allergies to drugs, adhesive tape, or bandages
Chest pain from a heart condition (angina)
Diabetes requiring insulin injections
Heart attack or heart disease
High blood pressure (severe)
Irregular heartbeat (heart arrhythmia)
Kidney disease
Liver disease
Overactive thyroid
Skin disease
Stomach ulcer

Users are cautioned that if their heartbeat becomes irregular or if they experience heart palpitations, they should stop using the patch immediately and contact a doctor. The patch should be discontinued until a doctor is consulted if redness caused by the patch doesn't go away in 4 days or if the skin swells or develops a rash.

Since the safety and effectiveness of nicotine patches have not been tested in children. OTC Nicotrol is not for use by children under age 18. Moreover, because a used nicotine patch still contains enough nicotine to poison a child or a pet, used patches must be disposed of with special care. There is a risk that if nicotine patches are used with certain other drugs, the effects of either could be increased, decreased, or altered. Thus, users are warned that it is especially important to check with a doctor before combining nicotine patches with any of the following:

Acetaminophen-containing drugs such as Tylenol
Caffeine-containing drugs such as No Doz
Certain airway-opening drugs such as Isuprel, Dristan, and Neo-Synephrine
Certain blood pressure medicines such as Minipress, Trandate, and Normodyne
Cimetidine (Tagamet)
Haloperidol (Haldol)
Imipramine (Tofranil)
Insulin
Lithium (Eskalith, Lithobid)
Non-nicotine quit-smoking drugs such as Zyban
Oxazepam
Pentazocine (Talwin)
Propranolol (Inderal)
Theophylline (Theo-Dur)

Finally, woman who are pregnant or plan to become pregnant, are advised to inform their doctor immediately if they intend to use the patch. Ideally, a pregnant woman should not take nicotine in any form since injury to the unborn fetus may occur.

Although the patch is used to stop smoking, it is a source of significant amount of nicotine and, thus, may also be harmful to an unborn baby.
Since nicotine passes easily into breast milk, the patch should not be used during breastfeeding. Smoking while wearing a patch gives the user a "double dose" of nicotine; if the user is pregnant or breastfeeding, the baby will also get a "double dose" of nicotine.

EMSAM (SELEGILINE) TRANSDERMAL PATCH FOR DEPRESSION

Only last week, the Food and Drug Administration (FDA) approved selegiline, which will be the first transdermal (skin) patch for use in the treatment of major depression in adults.

In its press release on the subject, the FDA stated: “Major depressive disorder is a common psychiatric condition in the U.S. population. Symptoms of depression include general emotional dejection, withdrawal and restlessness that interfere with daily functioning, such as loss of interest in usual activities; significant change in weight and/or appetite; insomnia; increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; and a suicide attempt or suicidal ideation.”

The new patch, which will be sold under the brand name Emsam, was developed by Somerset Pharmaceuticals, Inc. In December 2004, Bristol-Myers Squibb (BMS) and Somerset entered into an agreement that gives BMS (the world’s 8th largest drug company) distribution rights to market Emsam in the United States. Selegiline was initially approved in capsule form for use in the treatment of Parkinson's disease. The patch is only approved for adults, and will not be used to treat depression in children 17 and younger.

In a statement from BMS, its CEO, Peter R. Dolan stated: “We are pleased to be able to provide this important treatment to people with major depressive disorder. We believe Emsam will help physicians treat their patients living with this illness through a new and unique delivery system." Emsam interacts with three neurotransmitters in the brain that are believed to be involved with depression.

According to Dr. Steven Galson, Director of the Center for Drug Evaluation and Research, "Emsam provides a significant advance because at least in its lowest dose patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors.”

The FDA action comes about two years after the agency first said the patch was "approvable." The delay was caused by concerns that users of the patch may suffer potential interactions with certain foods.

The main concern is whether patients could have an adverse reaction if they consume foods high in tyramine, like aged cheese, salami and, to a lesser extent, beer and wine, while wearing the patch. The active ingredient in the patch, selegiline, could interact with tyramine a substance formed from the breakdown of protein as food ages causing a sharp and sudden surge in blood pressure.

In general, “MAO inhibitors usually require specific dietary restrictions because when combined with certain foods they can cause a sudden, large increase in blood pressure, or ‘hypertensive crisis.’ A hypertensive crisis can lead to a stroke and death. Symptoms of a hypertensive crisis include sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats (palpitations), sweating, and confusion. Patients who have these symptoms should get medical care right away.” (FDA Release)

The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline per 24 hours. “The patch is a matrix containing three layers consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.”

Patients using the patch at the lowest dose (6 mg per 24 hours) will not have any special dietary restrictions. Patients using the higher 9-mg and 12-mg patches, however, will be advised to avoid foods high in tyramine. Last year an FDA panel of independent medical experts said that at the lowest dose, the patch would be safely marketed, without any dietary restrictions, but recommended restrictions be made at the two higher doses.

Other issues mentioned in the FDA press release included the following potential side affects: “The only common side effect of Emsam detected in placebo-controlled trials was a mild skin reaction where the patch is placed. There may be mild redness at the site when a patch is removed. If the redness does not go away within several hours after removing the patch or if irritation or itching continues, patients are advised to contact their doctor.

“Another side effect that was seen less commonly was light-headedness related to a drop in blood pressure.” Also, the FDA noted that, like all approved antidepressants, the patch will carry a warning of increased suicidality in children and adolescents.

According to the FDA, the “manufacturer and distributor of this new product have planned an educational campaign for patients and prescribers to ensure that advice on dietary modifications for the higher patch strengths is adhered to. They plan to conduct both patient and health care provider surveys to assess the effectiveness of the educational campaign.

The manufacturer and distributor will also closely track reports of adverse events, and follow-up on those that might represent hypertensive crises, to further ensure the safe use of this product.” Although the effects of heat on the patch are not known, the drug labeling advises health care professionals and patients about the possible effects of direct heat applied to the Emsam patch.

“Direct heat may result in an increased amount of the drug absorbed from the patch. Patients should avoid exposing the patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, or prolonged sunlight.”

DURAGESIC (FENTANYL) PAIN PATCHES

One of the most problematic transdermal patches has been the one containing the powerful painkiller fentanyl. In fact, in July 2005, the FDA announced that it was investigating claims that the patch was responsible for some 120 deaths up to that point.

The Duragesic patch (Johnson & Johnson) was designed to provide up to 72 hours of relief from severe chronic pain associated with such conditions as bone cancer. Fentanyl, however, is a dangerous drug and an overdose of the narcotic (100 times more potent than morphine) can induce a coma and shut down breathing. Thus, improper administration of the drug or problems with the patch itself can have fatal consequences if either cause too rapid a release of the medication into the bloodstream.

Healthcare professionals and patients should be aware of the signs of fentanyl overdose, which include; troubled or shallow breathing, tiredness, extreme sleepiness, inability to think, talk or walk normally, and feeling faint, dizzy or confused. Patients experiencing these symptoms should get medical attention immediately.

Because of the extremely serious risks associated with this patch, Duragesic and its generic equivalent already carry a "black box" warning from the FDA. The FDA advised doctors to prescribe the lowest effective dose of the medication and not use fentanyl patches to treat short-term pain, or pain after an operation.

Patients were also warned not to use any patches that are damaged or broken and to not drink alcoholic beverages or bask in the sun while taking the drug because alcohol and a rise in body temperature can accentuate its effects.

In a strange story from October 2005, a West Virginia woman, who had been working as a nursing home aide, pleaded guilty to “neglect of a vulnerable adult” after admitting she removed a patient’s time-release pain patch in order to suck out the medication.

The former aide, 21-year-old Megan Oglesbee, was sentenced to 18 months in jail (suspended) and three years supervised probation. She must, however, complete substance abuse treatment and has been barred from caring for “vulnerable adults” in the future. A fine of $1,000 was also suspended by the judge.

The Attorney General’s office claimed that on October 15, 2004, while Oglesbee was a nursing assistant at Moran Manor Nursing Home in Westernport, West Virginia, a patient in her care had been prescribed a 72-hour transdermal pain patch.

The day after the patch had been applied; Oglesbee removed it, stuck a pin in the patch, and sucked out the medication. She then asked another nursing assistant to help her reapply the patch to the patient. When the second assistant became suspicious, Oglesbee admitted what she had done.

METHYLPHENIDATE TRANSDERMAL SYSTEM FOR ADHD

Late last year, FDA reviewers have concluded that an experimental skin patch designed to treat ADHD in children is not safe enough to be approved. The patch, known as the methylphenidate transdermal system (MTS) delivers a generic version of Ritalin through the skin. In 2003, FDA officials rejected the patch because induced high rates of anorexia, insomnia and weight loss in children when used for 12 hours.

The drug makers, Britain’s Shire Pharmaceuticals Group Plc, and U.S. Noven Pharmaceuticals Inc., have since conducted further tests, hoping to prove that MTS was safe and effective when used for 9 hours. The companies plan to market the patch as Daytrana, for use in children 6-12 years old.

But FDA officials said that the patch still causes too many dangerous side-effects. In addition to the problems cited on the initial clinical trials, the patch also poses a high risk of skin irritation and muscle tic.

According to the FDA staff: "The safety and tolerability profile of MTS treatment in these two new studies does not appear to be significantly more acceptable than that in the previous MTS submission."

The companies claim that the problems cited are no worse than ones that arise from pill versions of the medication. Experts say that while some of these side-effects do occur with the pills, the problems were more prevalent with the patch.

One serious drawback to this patch is that up to 22% of those who used the patch became so sensitive to it that they could never take the drug methylphenidate again, in any form.

FDA scientists also fear that abuse of the drug will occur with the patch, as it does with the tablet version. Studies show that Ritalin and other ADD and ADHD drugs are currently some of the most abused pills among youth and teens.

The biggest threat, experts say, would be children sharing the patch. But since the patch takes two to three hours to take effect, drug abusers would not get the same rush or high as they would get from taking a tablet.

All of the documents can be accessed online at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4195B-index -with-disclaimer.htm/.
Thus, despite the manufacturer’s claims that the ADHD patch is no more dangerous than existing pill versions of the medication, it would seem that the FDA cautious approach is fully justified. While the advisory committee recommended approval, it did so only in the case of children who could not swallow pills.

FDA TO INVESTIGATE THE TRANSDERMAL PATCH ISSUE

Since the safety of medications delivered by way of transdermal patches seem to present common problems, the FDA has decided to investigate the matter.

The agency will look at a number of factors that may affect absorption rates including the introduction of heat to the products themselves. Many experts claim that increasing the temperature of any transdermal patch will increase the absorption rate of the drug involved.

Several studies have shown that heat has a marked effect on absorption. For example, a1986 study found that 20 minutes of bicycling with a nitroglycerin heart medication patch increased concentration of the drug 200% to 300%. Similar results were found after half an hour in a sauna.

There is also the fact that the concerns associated with some of the more inherently dangerous drugs, or drugs that may become dangerous when taken in higher than recommended dosages, may not apply to medications where an increase in the absorption rate is less problematic.

Clearly, transdermal patches are convenient, ensure compliance with a drug regimen in people with problems remembering their medication schedule, and are particularly useful with drugs that require only lose dosages.

Before transdermal patches can be regarded as an acceptable and safe “delivery system,” however, much more research appears to be necessary. It may very well turn out that “patches” simply cannot be used for certain drugs that pose unacceptable risks when absorption rates may vary to the point of causing a dangerous overdose or other adverse reaction.

(Sources: Public Citizen – Worst Pills Best Pills; CBS News; Associated Press; Food and Drug Administration Web Site; Los Angeles Times; San Francisco Inquirer; Wall Street Journal; Newsinferno.com Archives)

Experts: Patches + heat = danger

Sun, 05 Mar 2006 00:00:00 -0800

Medical experts say medicated patches, used by 12 million people for a range of ailments, can become unsafe when heated by exercise, soaking in a hot tub, or even a high fever. And they think patients should be warned.

"Most people don't realize that heat is going to increase absorption rates, even to toxic levels," said Michael Cohen, director of the Institute for Safe Medication Practices, an industry watchdog in Huntingdon Valley.

Last week, the Food and Drug Administration said it was launching an "exhaustive review" of the safety of the patches themselves. Part of the review specifically studies how heat affects the products.

The FDA investigation comes eight months after the agency announced a probe into 120 deaths linked to fentanyl patches, which are used for chronic pain. In November, the agency issued a warning about birth-control patches after a study showed that women who wore the patch had 60 percent more estrogen in their blood than those on the pill.

In the last 25 years, patch medications have morphed from a simple motion-sickness drug to more than 30 prescription patches used by 12 million people worldwide for ailments ranging from bladder control to heart disease. Companies are marketing more and more versions - the first antidepressant patch was approved Monday.

Experts say that heat increases the absorption rate on all of them.

That's because all patches work the same way: The drug seeps through the skin into the bloodstream, and increased blood flow causes the body to absorb the drug faster, said Bozena B. Michniak, who studies transdermal patch delivery at the Center for Biomaterials at Rutgers University's Piscataway campus.

But not all hot patches will necessarily cause harm.

"It depends on the drug and the patch," Michniak said. "We could all say there will be an effect and absorption rate will increase, but how much? Many factors play a role."

The problem is most evident with the fentanyl patch, which is 100 times more potent than morphine. Since it was introduced in 1990, the drug has been linked to 120 deaths, the FDA reported.

FDA officials say that as few as 1 percent of all serious side effects are reported to the agency. Its database does not give details about the cause of death. The agency has been criticized, most recently in the recall on the arthritis pill Vioxx, for not paying attention to problems early on.

Whether a drug comes in a patch or not, the FDA does not say how many deaths should trigger an investigation or a recall. In 2000, the agency pulled the diabetes drug Rezulin after it was tied to 63 liver-failure deaths. Lotronex, a drug for irritable bowel syndrome, was recalled after it was linked to five deaths.

In 2004, patches overall were cited as the primary cause of death in eight cases, including two teens on birth-control patches, according to an Inquirer analysis of an FDA database.

In 2003, three people died, including a 45-year-old man and a 58-year-old woman on fentanyl pain patches.

Both years, the patch was a primary suspect in at least 30 cases in which patients were hospitalized, disabled or left with a life-threatening complication.

"The problems are real, they're happening and they're underreported," said Cohen, who sits on the FDA's Drug Safety and Risk Management Advisory Committee. "It's possible for people to get hurt."

The FDA database, the Adverse Event Reporting System, is based on mandatory reports of all kinds of drug reactions from pharmaceutical companies and voluntary data from doctors and hospitals. The data do not include whether heat was a factor in the problem, but mention the name of the drug, and whether it was a primary, secondary or concomitant factor in the incident.

The FDA database does not indicate with certainty that the suspected drug caused a reaction and does not include final investigation results.

Studies as early as 1986 showed that heat can double the rate at which the body absorbs medication, but there were no public warnings until 1994.

That came after the death of a 36-year-old Montgomery County man.

Kurt Hophan was given a fentanyl pain patch after a back injury. He went to his bedroom at his mother's house in Glenside and fell asleep with a heating pad and an electric blanket.

"When the heat from the pad and the electric blanket came into contact with the patch, the amount of fentanyl released into Mr. Hophan's bloodstream was approximately one hundred (100) times greater than the amount prescribed," according to the judge's ruling in a lawsuit filed against the drug's manufacturer by his mother, Elaine Hophan.

He never woke up. He died on March 4, 1994.

In 2001, a jury awarded his mother $5 million in compensatory damages. After an appeal, the case was settled under a confidential agreement, said Stephen Raynes, who represented Elaine Hophan.

The warning appeared three months after Hophan's death. Johnson & Johnson declined further comment.

There's no question that there are benefits to patch medication, and that millions of consumers use patches safely.

They are easier on the body because medicine is absorbed through the skin into the bloodstream, without a "first pass" through the liver and the stomach. That often means a smaller dose is required.

Plus, it's convenient.

"Patches improve compliance, particularly for people who have to take medication several times a day or for people who forget," said Sean Hennessy, pharmacology professor at the University of Pennsylvania and another member of the FDA's drug safety committee.

And they are popular. In 2004, patch sales totaled about $3.4 billion, according to Greystone Associates, a medical market-research firm in New Hampshire.

The patch comes in two main forms: the liquid reservoir and the matrix.

In the liquid-reservoir version, such as the fentanyl patch, the medicine is embedded into a gel-like substance in the center, and released through a membrane into the skin.

The matrix patches contain the medication within the adhesive that adheres to the skin, often using the flesh as the rate control - because the skin can absorb only so much, so fast.

The patch is not for every drug, said John Urquhart, professor of biopharmaceutical sciences at the University of California at San Francisco and one of the creators of the original motion-sickness patch.

"A lot of morons out there think you can put a drug in a patch and it will sell like hotcakes," Urquhart said.

To work well in a patch-delivery system, he said, the drug has to be effective in small doses. The medicine should not cause irritation (which increases absorption), and should have a wide safety margin to prevent accidental overdose, which can occur when it is heated.

Multiple studies have shown that heat has a sharp effect. A 1986 study found that just 20 minutes of bicycling with a nitroglycerin heart medication patch increased concentration of the drug twofold to threefold. Similar results were found after 30 minutes in a sauna.

"In chemistry, if we want to speed up a reaction, you apply heat," said Robert Middleberg, laboratory director of National Medical Services in Willow Grove. "It's silly for us to believe that heat wouldn't play a factor in a drug-delivery device that works with the skin."

The independent lab receives thousands of unexplained-death cases from medical examiner's offices nationwide. Of the 100 or so patch-related deaths he gets each year, about 70 percent are caused by patient misuse and 15 percent more are due to drug abuse. The rest, Middleberg said, cannot be explained, and he thinks they are likely due to a problem with the patch.

"The dynamics of the patches are not really completely understood," he said.

Most of the patch-related deaths that Middleberg sees involve fentanyl.

"You find reports of death with other patches, most notably nitroglycerin patches," he said. "But they are really hard to prove because nitro just falls apart in the body and you're left wondering what really happened."

One company, ZARS Pharma, based in Salt Lake City, specifically uses heat with its patch products, including an anesthetic one approved by the FDA in June and marketed by a Chadds Ford company, Endo Pharmaceuticals Holdings Inc.

Their two patch products work differently. The pain patch, under development, comes with a separate device, similar to a heating pad, that is placed over it. The anesthetic patch heats up when exposed to air, much like over-the-counter hand warmers.

Skin temperature is usually about 89.6 degrees Fahrenheit, but increasing that temperature up to about 102 degrees can quadruple the absorption rate, said Michael Ashburn, ZARS vice president for clinical and regulatory affairs. That can happen in as little as 20 minutes, he said.

"You have to be able to control the temperature so we know what's getting through," Ashburn said.

Although uncontrolled amounts of narcotics, such as fentanyl, could have fatal results, it's unclear what higher doses of other drugs could do.

"I don't think you can kill yourself with a nitro patch; you'll just make yourself feel dizzy," said Gordon Flynn, professor of pharmaceutics at the University of Michigan and a consultant for Mylan Pharmaceuticals Inc. "You're not supposed to be on it continuously."

In December, the FDA began to study how heat affects the absorption rates of all patches under various circumstances, said Lucinda Buhse, director of the FDA's Division of Pharmaceutical Analysis.

"We would like to develop a method that's applicable across the board with different drugs and different patches," she said.

The investigation will focus on fentanyl and birth-control patches first, to see how they react to hot tub and sauna heat, among other scenarios.

Douglas Stokke, a spokesman for Johnson & Johnson, which makes the fentanyl patch and Ortho Evra birth-control patch, said the company did not have clear information about the FDA study. When asked whether doctors should warn patients about exposure to heat while wearing a patch, he said: "Physicians should be knowledgeable about the prescribing information for these products and should be prescribing them according to labeling."

But, says Michniak, of Rutgers, those who use patches should be careful about sitting in the sun, using heating pads, or doing anything else that might increase the skin temperature for a long time.

"If it's not in the patient insert, they may not be as aware as they should be," she said.

One patch whose safety is being questioned is the Ortho Evra birth-control patch. Last year, doctors wrote more than 9.4 million prescriptions for it, according to IMS Health, an industry monitoring firm based in Plymouth Meeting.

In November, the FDA released a study saying that women who wore the patch had far more estrogen in their bloodstream than those who took the pill. Researchers aren't sure why. Four months later, Johnson & Johnson released a study stating that women who wore the patch had twice the number of blood clots, which can cause strokes and heart attacks.

On the same day, another study, published in the journal Contraception, said there was no additional risk compared with the pill's risks.

Vanessa Cullins, an ob/gyn and vice president for medical affairs for Planned Parenthood, said the patch came under fire unfairly.

In the J&J study, Cullins noted that rates for blood clots were as high as four per 10,000 on the pill and eight per 10,000 on the patch.

Cullins said that, even if the increase was real, "it's still a very rare event."

Women should weigh the risks and benefits of the patch, she said, noting that it may not be appropriate for those with a family history of blood clots or strokes.

Since July, more than 40 lawsuits have been filed nationwide, claiming that blood clots caused by the patch killed or injured women.

While studies into patch safety continue, more proposals for new transdermal medications are appearing before the FDA.

Next up is Daytrana, a controversial methylphenidate patch specifically for children with attention deficit hyperactivity disorder. In June, FDA medical officer Robert Levin said the patch resulted in "excessive drug exposure at inappropriate times," vomiting, and a high risk of causing a tic. He suggested that it not be approved.

Seven months later, Levin changed his mind. In December, he told an FDA advisory committee that the patch, aimed at 6- to 12-year-old children, did not cause significantly different problems than Concerta, an ADHD pill. With one exception: Up to 22 percent of those who used the patch became so sensitive to it that they could never take the drug methylphenidate again, in any form.

The ADHD patch lasts nine hours, and members worried that children would be responsible for their removal and not take it off in time. "Theoretically, it is possible that continued exposure could increase the risk of insomnia and other adverse events," Levin said.

The FDA did not respond to multiple requests to interview Levin and to questions about the database.

The committee unanimously recommended the patch, but only for children who cannot swallow pills. It is now under FDA review.

Painkiller overdose links four deaths

Thu, 23 Feb 2006 00:00:00 -0800

Aiken County Coroner Tim Carlton couldn't help but notice the trend.

When the toxicology reports came back on Shawn Noe recently, it was the fourth time in just a few months that someone in Aiken County had died from overdosing on the popular painkiller fentanyl.

It set off some alarm bells, Mr. Carlton said, especially since he normally handles just six to 10 deaths caused by drug overdose a year, with no common fatal potion in all of them.

The coroner is at a loss to explain why fentanyl, which the Drug Enforcement Agency says is virtually "indistinguishable" from heroin in its effects on the user, is suddenly killing people in Aiken County.

"I don't know if it's easier to get, or if it's being used more widely for chronic pain," he said.

The recent string of deaths in Aiken County began with 43-year-old Aiken resident Donna Parker on Sept. 8.

Since then:

Mary Deel, 34, of Aiken, died Dec. 25;

Josie Douglas, 55, of Aiken, died Jan. 4;

And Shawn Noe, 40, of Warrenville, died Jan. 20.

Authorities said two of the overdose victims: Ms. Douglas and Ms. Parker likely obtained the drug illegally because they did not have a prescription.

Fentanyl is commonly prescribed in the form of an adhesive patch and is used for chronic pain. Mr. Carlton said it has a street value of about $100 per patch.

Not only does fentanyl have similar effects as heroin, it is taken virtually the same way when misused.

Mr. Carlton said he believes that the four people who overdosed on the drug scraped the fentanyl off the inside of the patch, heated it up and then injected or inhaled it.

Mr. Carlton said he can't recall any previous overdose deaths in Aiken County linked to fentanyl since he has been coroner.

Overdosing on the drug, he said, causes respiratory failure and then cardiac arrest.

Aiken County Sheriff's Investigator Charles Barranco said the department's narcotics division hasn't found fentanyl to be a widespread problem.

But with the recent deaths, he said, narcotics investigators are now really "looking for it."

Family sues over Rx drug

Thu, 15 Dec 2005 00:00:00 -0800

The family of a Salt Lake area woman who died two years ago of multiple organ failure has filed a lawsuit against the maker of a pharmaceutical skin patch she was using to control pain.

Duragesic distributor, ALZA Corp., is being sued by the family of Marilyn Titus, who died Dec. 14, 2003, at age 72, two months after she began having serious side-effects from the pain medication fentanyl she was receiving through a skin patch, the lawsuit states.

She had sought help managing her chronic pain from two doctors, one of whom prescribed 50 micrograms of fentanyl dispensed timed-release through the patch, according to the suit.

Titus' first prescription 10 patches was filled at a local pharmacy in October 2003. On Nov. 22, she began to have difficulty breathing and lost consciousness while talking to a 911 dispatcher. She was taken to Pioneer Valley Hospital and airlifted to University Hospital, the lawsuit contends.

The Food and Drug Administration said earlier this year that it is investigating the patch, which it said is linked to deaths and poses risks that users might not understand.

In a suit filed in 3rd District Court on Tuesday, the family alleges that ALZA and a partner company, Janssen Pharmaceutica Products, sold defective and leaking patches to Titus and others in Utah and elsewhere. Officials with those companies could not be reached for comment late Wednesday.

Titus was diagnosed with Paget's disease, which caused her to experience episodes of extreme back pain, the complaint states.

The complaint against the two companies states they negligently and carelessly researched, tested and distributed the patches and failed to warn users of the patch's risks.

The FDA on its Web site issued a public health advisory in July stating the patches may cause death from overdose. "Patients who are using the fentanyl skin patch and their caregivers should be told about the directions for safe use of the patch and should follow the directions exactly," the advisory states.

Symptoms of fentanyl overdose are troubled or shallow breathing, tiredness, extreme sleepiness or sedation, inability to think, talk or walk normally and feeling faint, dizzy or confused.

A Los Angeles Times story in November stated that the county coroner's office there had investigated more than 230 deaths involving fentanyl in the past six years. More than 100 of those deaths were classified as accidental. From 2000 to 2004, sales of Duragesic more than tripled and the number of prescriptions more than doubled, the paper reported. In 2004 alone, 4.1 million prescriptions for Duragesic were filled. While initially developed for cancer patients, the patch has become increasingly common for sufferers of other types of pain that may not be as closely monitored.

The complaint states package labeling lacked adequate information about the use of fentanyl patches and warnings of potential side effects.

The suit alleges the companies knew of injuries and deaths the patches caused and failed to recall them.

Marilyn Titus' husband, Robert, and daughter, Robyn Hastings, are suing the two companies and any others that may be found linked to the sale and marketing of Duragesic for damages that include medical expenses, funeral costs, out-of-pocket expenses, loss of love, companionship and economic support, punitive damages and attorney fees all to be determined at trial.

Pain patch required special monitoring

Sun, 27 Nov 2005 00:00:00 -0800

Dory Bauler prides herself on staying active despite painful back problems. But earlier this year, she was getting so short of breath that she could barely walk. Doctors could find nothing wrong.

It never occurred to them that the medicinal patch she was using to deliver pain relief might also be poisoning her.

''I was just shutting down,'' said Bauler, 76, a retired paralegal from Laguna Woods, Calif., who suffers from a severe curvature of the spine.

Bauler's patch was delivering fentanyl, a narcotic many times more powerful than morphine. Like morphine and other opioid drugs, fentanyl controls pain but also reduces respiratory function. Luckily, Bauler figured out what was happening in time to stop using the drug. Too much fentanyl can shut down the respiratory system.

The leading brand of the fentanyl patch is Johnson & Johnson's Duragesic; last year, pharmacists filled more than 4 million prescriptions for it.

The drug was developed to help people in extreme, constant pain. Misuse can be lethal.

The fentanyl patch illustrates a broad and still-unresolved problem with the nation's system for protecting patients against drug risks: Neither the FDA nor the pharmaceutical industry has a comprehensive system for monitoring what happens after a new drug is approved for market.

Sometimes, as with the highly publicized discovery of heart and stroke risks associated with the painkiller Vioxx, the problem is that dangers show up only after millions of people begin using a drug. At other times, as with fentanyl, the problem is that a drug approved for one purpose can be prescribed and used for other purposes. Known as off-label use, the risks are not always understood.

Cancer patients, for whom the fentanyl patch was developed, are usually monitored closely by a physician. Often, however, the patches are being prescribed for other conditions, sometimes without close monitoring.

The FDA says it is investigating about 130 fatalities that occurred over a 15-year period. Results of autopsies in Los Angeles and Florida suggest the number of fentanyl-related deaths may be much higher.

''There are hundreds more cases not evaluated by the FDA,'' said Bruce Goldberger, director of toxicology at the University of Florida Medical School.

In Los Angeles County, criminalist Daniel Anderson of the coroner's office said the ''vast majority'' of the 237 people whose deaths involved fentanyl had used the patch. The deaths occurred over a 5 ½-year period.

Of those, 127 were classified as accidental, suggesting that patients misunderstood how to avoid the drug's risks.

In Florida, state authorities reported 115 deaths from fentanyl poisoning in 2004, records show. Goldberger, whose office handles about one-fourth of the autopsies in the state, said the majority involved the patch.

Drug abuse involving fentanyl also is on the rise. Emergency room mentions of the drug rose from 28 in 1994 to 1,506 last year, according to the federal Substance Abuse and Mental Health Services Administration.

Duragesic sales more than doubled from 2000 to 2004 as manufacturer Johnson & Johnson touted its safety in advertising to doctors that the FDA called ''misleading.'' Yet as early as 2001, a drug safety group had publicly warned that patients on the patch were dying of overdoses.

It took another four years for the FDA to issue its own nationwide alert, on July 15.

Dr. Robert Meyer, head of the FDA office that oversees painkillers, said that earlier this year safety officers noticed a trend of adverse reactions involving the drug.

''The system in place, though never ideal, does work well,'' Meyer said. ``The FDA did the right thing in [issuing] its communication. One of the things we need to think about in the future is continuing communications in terms of drugs like this that have some safety concerns.''

Public Advisory Health Canada Endorsed Important Safety Information DURAGESIC* (fentanyl transdermal system)

Fri, 16 Sep 2005 00:00:00 -0700

Janssen-Ortho Inc., in collaboration with Health Canada, wishes to highlight important safety information about the safe use of DURAGESIC.

The Canadian Product Monograph for DURAGESIC has been revised to emphasize this safety information, and contains a section with Consumer Information to ensure that patients and their caregivers are aware of the guidelines for the safe use of DURAGESIC.

DURAGESIC contains a high concentration of a potent and long-acting narcotic agent called fentanyl, which is administered through the skin by a patch system to relieve pain.

Fentanyl, similar to other strong opioid pain medications, has demonstrated a risk of fatal overdose. The most serious effect of fentanyl overdose is hypoventilation (slowed breathing). Serious or life-threatening cases of hypoventilation (including deaths) have been reported in association with the use of DURAGESIC.

Other symptoms of fentanyl overdose include difficult or shallow breathing, tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.

Patients and their caregivers should be aware of the signs and symptoms of fentanyl overdose, and should seek medical attention immediately if any of these symptoms are noted.

DURAGESIC is used in adults for the management of persistent, moderate to severe chronic pain that cannot be managed by lesser means. It should not be used for short-term, intermittent or post-operative pain, or in patients who are not already using some form of strong opioid pain medication.

The use of DURAGESIC in children under 18 years of age is not recommended, as dosage requirements for the safe and effective use of DURAGESIC have not been established for children. There have been reports of deaths in children using DURAGESIC in Canada.

The potential for serious adverse events may be increased in patients who use DURAGESIC along with some other prescription medications that affect how fentanyl is broken down in the body.

Patients should tell their doctors if they are taking any other prescription medications; use DURAGESIC in combination with alcohol and any other medications: such as sleeping pills, muscle relaxants, antihistamines or any other over-the-counter medications that affect brain functions; have fever; are exposed to direct external heat sources.

All patients who use DURAGESIC should be advised to avoid external heat sources such as heating pads, electric blankets, heated water beds, heat lamps, hot water bottles, saunas and hot whirlpool spa baths, intensive sunbathing, etc. do not follow exactly the directions for safe use or the approved labeling.

The potential exists for misuse and abuse of DURAGESIC patches. There have been reports of deaths in Canada involving misuse and abuse. Consumers should be aware of the importance of safe storage and proper disposal instructions for DURAGESIC.

Patients, family members and caregivers should protect DURAGESIC from theft or misuse in the work or home environment.

The Canadian Product Monograph currently recommends to fold the patch such that the adhesive side sticks to itself and to flush it down the toilet immediately after removing it from the skin. Any unused patches should be disposed of in the same manner.

Janssen-Ortho Inc. has provided this information to physicians and pharmacists across Canada. This advisory and letters issued to physicians and pharmacists can be accessed at Health Canada's website.

Pain Relief Patch Studied In 120 Deaths

Sat, 16 Jul 2005 00:00:00 -0700

Federal regulators are investigating about 120 reported deaths that may be linked to overdoses from a pain relief patch that administers a potent narcotic through the skin, the Food and Drug Administration said Friday.

Johnson & Johnson's Duragesic patch can provide up to three days' relief from severe chronic pain, such as that experienced by bone cancer patients. But fentanyl, its active ingredient, is highly dangerous. An overdose of the morphine-like drug can put a patient into a coma and shut down breathing.

Fentanyl gained international notoriety in 2002, when Russian authorities trying to end a hostage crisis at a Moscow theater pumped in a gas reportedly containing the drug, intending to put the hostages and their Chechen captors to sleep. Of the 750 hostages, about 120 died, nearly all from breathing the gas.

FDA officials said they are investigating whether the deaths among U.S. patients could be the result of unintentional fentanyl overdoses. Such overdoses could come about if patients and doctors do not faithfully follow a series of precautions contained in the prescribing literature, or label, for the drug.

Other possible explanations include rare problems or defects with the patches themselves that would cause too much of the drug to be released into the body too quickly.

Doctors and patients should be aware of the signs of fentanyl overdose, which include trouble breathing or shallow breathing, tiredness, extreme sleepiness, inability to think, talk or walk normally and feeling faint, dizzy or confused, the FDA said. Patients experiencing these symptoms should get medical attention right away, the FDA said.

FDA officials said the agency announced the investigation in keeping with its new commitment to give the public warning of possible problems with prescription drugs. The FDA has been strongly criticized for taking too long to respond to evidence of heart attack risks with Vioxx and other arthritis drugs, and to evidence of suicide risks for teenagers taking anti-depressants.

The fentanyl investigation is in its early stages, FDA officials said, and the agency has reached no decision on whether the patches should be recalled, or their use limited. But the FDA did issue a new public health advisory Friday underscoring the need for patients to follow precautions for using the drug scrupulously.

Because of its risks, Duragesic and its generic equivalent already carry a so-called "black box" warning, the FDA's most emphatic.

On Friday, the agency underscored those warnings.

Doctors should prescribe the lowest effective dose of the medication, said the agency. And fentanyl patches should not be used to treat short-term pain, or pain after an operation. Patients should not attempt to use any patches that are damaged or broken. And they should not drink alcoholic beverages or bask in the sun while taking the drug because alcohol and a rise in body temperature can accentuate the effects.

FDA Issues Public Health Advisory on the Fentanyl Patch

Fri, 15 Jul 2005 00:00:00 -0700

The FDA today issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches.

These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.

The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.

Family Files Lawsuit Over Recalled Drug Patch

Wed, 21 Apr 2004 00:00:00 -0700

A lawsuit claims a pain medication patch contributed to the death of a Maryland woman, who drowned in her bathtub.

The family of 51-year-old Patricia Wroten is suing Johnson and Johnson and a subsidiary that makes the Duragesic patch. The suit seeks $25-million.

The suit claims the patch leaked dangerous levels of opiates into the woman's body in February. They say she was washing her hair in the tub when the effects of the drug hit her, causing her to pass out and drown.

The Johnson and Johnson subsidiary had recalled a batch of the patches that same month after finding that some of them leaked medication along one edge.

The lawsuit says the patch worn by Wroten when she died was from the recalled lot but that a warning of the problem came only after her death.

Company Recalling Its Pain Skin Patch

Fri, 09 Apr 2004 00:00:00 -0700

The maker of a skin patch used to treat pain is voluntarily recalling its product.

Janssen Pharmaceutica Products, L.P., is expanding its U.S. recall of the Duragesic pain patch to include five lots of the product.

The patches are coated with an opiate gel, and the manufacturer says some of the patches may leak, causing patients to get too much or too little medication.

The leak could lead to an overdose or withdrawal symptoms.

Anyone who has 75 mcg/hour DURAGESIC patches should examine the control number that appears on the bottom flap of the outer carton or back of the foil pouch. Those who have patches from lots with control numbers 0327192, 0327193, 0327294, 0327295, and 0330362 must contact their physician or pharmacist immediately for specific instructions on returning patches from recalled lots and obtaining a new supply.

Patients wearing other dosage strengths or Duragesic patches that are not from the recalled lots can continue to wear them. Sudden discontinuation of Duragesic can cause serious health problems.

Recall of Painkiller Patch Widened

Thu, 08 Apr 2004 00:00:00 -0700

Janssen Pharmaceutica has announced what the company called an "urgent" expansion of its recall of its painkiller patch Duragesic because of a leak that could cause life-threatening complications.

Janssen originally announced the recall of one batch in February, but now the recall has widened to four more batches.

The transdermal patches contain the opioid fentanyl in gel form. The company discovered that a seal along one edge allowed the drug to leak onto the skin. As a result, users could either be not getting enough, which can lead to withdrawal systems, or too much, which can lead to dangerous overdoses.

The recall applies to Duragesic patches releasing 75 micrograms per hour. The control numbers listed on the package are: 0327192, 0327193, 0327294, 0327295, and 0330362. Patients and caregivers who are exposed to the gel are urged to wash their hands with water only; soap should not be used.

Janssen Pharmaceutica Expands Nationwide Recall Of 75 mcg/Hour DURAGESIC (Fentanyl Transdermal System) CII Patches

Mon, 05 Apr 2004 00:00:00 -0700

Janssen Pharmaceutica Products, L.P., is expanding its U.S. recall of DURAGESIC (fentanyl transdermal system) CII 75 mcg/hour patches to include five manufacturing lots (control numbers 0327192, 0327193, 0327294, 0327295 and 0330362). No other dosage strengths or control numbers are affected. Available by prescription only, DURAGESIC patches contain a potent opiate medication.

The company recalled one lot of DURAGESIC 75 mcg/hour patches (control number 0327192) in February 2004 after determining that some patches in this lot might leak medication along one edge. Since then, patches with the same problem have been identified in one additional lot. As a precaution, the company is recalling four additional lots of 75 mcg/hour patches that were produced on the same manufacturing line during the same period.

DURAGESIC patches contain a strong opiate in the form of a gel. If the gel leaks from the patch, patients can get either too much or too little medication. Exposure to too much medication can occur if the gel leaks directly onto the skin and the body absorbs a higher than intended amount or if any of the medication is swallowed accidentally. This overexposure may cause potentially life-threatening complications. If the drug leaks out, there may not be enough medicine to achieve the desired effect and the patient may experience withdrawal symptoms.

The gel should not be touched if it leaks from a DURAGESIC patch. If a patient or caregiver has unintended contact with the gel, they should immediately wash the affected area with large amounts of water only; soap should not be used. Patients should speak with their pharmacist or physician for further instructions.

Anyone who has 75 mcg/hour DURAGESIC patches should examine the control number that appears on the bottom flap of the outer carton or back of the foil pouch. Those who have patches from lots with control numbers 0327192, 0327193, 0327294, 0327295 and 0330362 must contact their physician or pharmacist immediately for specific instructions on returning patches from recalled lots and obtaining a new supply. Patients wearing other dosage strengths or DURAGESIC patches that are not from the recalled lots can continue to wear them. Sudden discontinuation of DURAGESIC can cause serious health problems.

The affected lots were shipped only to distributors in the U.S. between mid-December 2003 and early March 2004. Based on historic usage rates, the company estimates that the majority of patches in these lots already have been used. The company has consulted closely with the U.S. Food and Drug Administration on this expanded recall as well as the initial recall of DURAGESIC 75 mcg/hour patches in February 2004.

DURAGESIC patches are available in four dosage strengths 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour. Only DURAGESIC 75 mcg/hour patches from lots with control numbers 0327192, 0327193, 0327294, 0327295 and 0330362 are affected by this expanded recall. No other lots of the 75 mcg/hour patches are affected. No other dosage strengths are affected.

Drug Company Expanding Recall of Pain Patches

Sun, 04 Apr 2004 00:00:00 -0800

Janssen Pharmaceutica Products is expanding a recall of 75 microgram-per-hour prescription Duragesic patches, which are used to treat moderate to severe chronic pain.

Janssen recalled a single manufacturing lot of 440,000 patches in February after determining that some of them were leaking medication along one edge.

The Johnson & Johnson subsidiary said Monday that it is adding patches from four additional manufacturing lots to the initial lot included in the original recall.

A total 2.2 million patches from five lots with the control numbers 0327192, 0327193, 0327194, 0327195 and 0330362 are now affected.

About 21 percent of those patches may still be in distribution, said Janssen spokeswoman Carol Goodrich. No other dosage levels are affected, the company said.

If the medication leaks from the patch, patients can get either too much or too little medication.

It's possible for a person to absorb a higher than intended amount if the medicine leaks directly onto the skin. Overexposure may cause nausea, sedation, drowsiness or potentially life-threatening complications.

If too little medication is left, it may not be enough to provide adequate pain control, and the patient may experience withdrawal symptoms.

Duragesic Patch Lawyer Side Effects Lawsuit Overdose Attorney

Sun, 04 Apr 2004 00:00:00 -0800

DOWNLOAD OUR INFORMATION PACKAGE

Injured by the Duragesic Patch?

Keywords: Duragesic | Lawyer | Death | Attorney | Injury | Overdose | Lawsuit

On July 15, 2005 the FDA issued a Public Health Advisory concerning the use of Duragesic Patches (Fentanyl transdermal) in response to reports of deaths in patients using the patch. The FDA is conducting an investigation into the deaths associated with these patches.

Our Dedicated Lawyers and Attorneys Have Years of Experience
Handling Defective Drug Lawsuits Such as Duragesic!

The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.

There has been an expanded recall of Duragesic Patches due to possible leaks. Janssen Pharmaceutica, the manufacturer of the Duragesic Patch notified healthcare professionals of an expanded recall of the Duragesic 75 mcg/h, in February 2004. Four additional lots have been subject to the present expanded recall. Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.

Once You Fill Out The Duragesic Case Review Form, One of Our
Lawyers Skilled In Defective Drug Litigation Will Contact You.

If the medication leaks out of the patch, exposure to the medication can result in inadvertent ingestion or increased transdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of the medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.

The Duragesic Patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics.

Moreover, only patients who are already on and tolerant to opioid therapy, and require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, the Duragesic patch releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription.

If you or a loved one used a Duragesic Patch and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects lawyer / attorney.