http://www.yourlawyer.com/topics/overview/darvocet Sat, 21 Nov 2009 02:42:43 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16718 Tue, 07 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16718 Darvon, Darvocet and other painkillers that contain propoxyphene are being required to strengthen the drugs' labels, including their boxed warning, to emphasize the potential for overdose.  However, the Food & Drug Administration (FDA) has rejected a petition from a  consumer advocacy group to remove Darvon and similar drugs from the market.

Propoxyphene has been on the market since 1957. It is a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain. The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.

Like certain other classes of pain medications, propoxyphene products can be addictive and have been linked to deaths in patients, especially when used with alcohol and other drugs.  The drug labels' currently warn of those risks. In February, an FDA advisory panel had voted  14-to-12 to withdrawal drugs like Darvon from the market, citing its overdose risks.   However, the FDA is not bound to follow the recommendations of its advisory panels.

In addition to the stronger label warnings, the FDA is requiring the manufacturers of these drugs to provide a medication guide to patients stressing the importance of using the drugs as directed.  

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes.  At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.

In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

However, the FDA also said today that it had rejected a petition from the advocacy group Public Citizen  requesting a phased withdrawal of propoxyphene. The agency said in its response that despite serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time.

The Public Citizen petition was filed in 2006.  In 2008, the group filed a federal lawsuit seeking to force the FDA to act on the petition.

]]> http://www.yourlawyer.com/articles/read/15967 Fri, 30 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15967 Darvon and Darvocet might be removed form the market.  The U.S. Food and Drug Administration (FDA) has convened an expert medical panel to make a recommendation regarding the fate of the two popular pain pills, reported Dow Jones.  Over 20 million prescriptions for the drugs have been written since 2007, said the FDA.

Eli Lilly & Company’s Darvon, contains the active ingredient propoxyphene and has been on the U.S. market for over 50 years, said Dow Jones.  When Lilly later added propoxyphene with the pain medication acetaminophen, it was sold as Darvocet.  Today, the medications are manufactured and marketing by private, generic drug makers such as Xanodyne Pharmaceuticals Inc. of Newport, Kentucky and Qualitest/Vintage Pharmaceuticals, of Huntsville, Alabama, said Dow Jones.

Approved for mild to moderate pain, the propoxyphene medications have been linked to death in patients—especially when used with alcohol and other drugs—and have also been found to be addictive.  According to FiercePharma, it is because of the potential abuse that the FDA advisory committee has been called in to help determine if the drugs should or should not remain on the market.  The WSJ reported that the FDA said the panel needs to look at the drugs’ pain-killing efficacy.

The Wall Street Journal (WSJ) reported that the move by the FDA followed a petition and subsequent lawsuit filed by the advocacy group, Public Citizen, which included information from the Drug Abuse Warning Network that revealed that propoxyphene was involved in 5.6 percent of all drug-related deaths from 1981 to 1999 as well as 2,110 accidental deaths.  Public Citizen is calling for the ban saying that the medications are “relatively weak” pain medications in which “"toxicity develops at only slightly above the recommended daily dose," reported the WSJ.  The Journal said that an FDA memo—part of the meeting documents—indicates that the FDA has insufficient information in its files to justify the ban.

The Public Citizen petition, which was filed against the FDA two years ago, followed the United Kingdom ban of propoxyphene pain killers over concerns of abuse and fatalities linked to the drugs, said the WSJ, which pointed out that Public Citizen has been asking for the drug ban since 1978 when the FDA was operating under the Department of Health, Education, and Welfare.  When the FDA did not act on the petition in 2006, Public Citizen filed suit against the agency, said the WSJ.

Dow Jones reported that an FDA review of its adverse-event reporting data base confirmed 3,028 serious and non-serious reports linked to propoxyphene from 1957 through September 24, 2008; 2,136 reports were considered serious and1,452 ended in death.  The FDA noted that much of the reports involved suicides, intentional and unintentional drug overdoses, and heart attacks; some reports indicted multiple drugs, said Dow Jones.

The two companies marketing the drugs generically said, according to Dow Jones, that over 600 million prescriptions for propoxyphene drugs have filled in the past five decades.

]]> http://www.yourlawyer.com/articles/read/14622 Fri, 20 Jun 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14622 Darvon and Darvocet is too risky to stay on the market, says Public Citizen, a consumer advocacy group suing the US Food and Drug Administration (FDA).

Pubic Citizen petitioned the FDA two years ago to ban Propoxyphene saying it was not any more effective than other, safer painkillers and pointing to at least 2,110 accidental deaths between 1981 and 1999.  Several hundred more accidental deaths have been linked to Darvon/Darvocet every year since, according to Public Citizen’s Health Research Group in its petition, which is planned for submission to FDA acting Commissioner Dr. Andrew von Eschenbach. Public Citizen first sought to ban Propoxyphene in 1978.

The lawsuit was filed in US District Court in Washington and argued that the FDA was in legal violation by not ruling on its petition within the required six months.  The lawsuit states that Propoxyphen is an addictive narcotic that, even when used properly, can cause slowed heartbeat and other serious cardiac side effects.  This February, Public Citizen’s Health Research Group asked the FDA to ban Darvon and Darvocet, two popular painkillers.  Dr. Sidney Wolfe, the group’s director, said Propoxyphene, the drugs’ main active ingredient, is a relatively weak painkiller that presents an unacceptable toxic risk to millions of patients taking it annually. “This a black-and-white example of a drug where its risks far outweigh its benefits … there’s no excuse for this drug to be around” said Wolfe.

Prescriptions for the drug—which has been sold since 1957—have decreased, but 23 million prescriptions were still written for propoxyphene-containing drugs last year.  Darvocet combines propoxyphene with acetaminophen and is the most popular of these types of painkillers.

An analysis of 26 studies comparing propoxyphene and acetaminophen with just acetaminophen or a placebo found the “narcotic combination offered little benefit over acetaminophen alone” in treating pain.  “Thus, propoxyphene provides minimal if any additional analgesia to acetaminophen alone and is associated with significant adverse effects.  It cannot be recommended for routine use,” Dr. Carolyn Sachs of the University of California, Los Angeles, wrote in her analysis, published in March 2005 in American Family Physician.

Wolfe said a “phase-out,” meant to wean users from the drug would be followed by a ban, similar to a move in 2005 by the United Kingdom over Co-proxamol, Britain’s most frequently used drug.  Co-proxamol was banned over concerns about the high risk of accidental death from slight overdose and its frequent use in suicides.  Co-proxamol, is sold under the brand names Distalgesic, Cosalgesic, and Dolgesic in the UK and under the names Darvocet and Darvon in the US.

The body transforms propoxyphene—or codeine—Into norpropoxyphene, which can build up in the body and is associated with a variety of heart problems, including arrhythmia.  Propoxyphene is among the nation’s most widely abused painkillers, Substance Abuse and Mental Health Services Administration spokeswoman Leah Young said, adding that a 2004 survey found 21 million people had made “non-medical” use of products containing propoxyphene.

]]> http://www.yourlawyer.com/articles/read/11419 Wed, 01 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11419
(http://www.citizen.org/publications/release.cfm?ID=7420) with the Food and Drug Administration “pursuant to the Federal Food, Drug and Cosmetic Act 21, U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30 to immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products such as Darvocet (propoxyphene and acetaminophen).”

The petition to ban the popular pain reliever propoxyphene, known as Darvon, Darvocet and other generic versions, stems from the drug having “been linked with more than two thousand accidental deaths” and because it “is physically addictive and has not been shown to be any more effective than safer alternatives.”

The petition states that 5.6% of all drug related deaths during the past 19 years were related to propoxyphene, according to data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the US.

Yet despite this alarming rate of deaths, the drug remains widely prescribed, with 23 million prescriptions filled in 2004, making propoxyphene the 12th most commonly prescribed generic drug in the US. 

According to Public Citizen, since 1981, propoxyphene has been associated with 2,110 reported accidental deaths in the US. Many of these deaths occur because most of the drug converts into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression.

Negative heart problems associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a disabling of the heart to contract properly.

"The number of deaths involving propoxyphene in the U.S. alone is striking," says the petition, filed by Public Citizen and two Swedish experts on propoxyphene, Drs. Ulf and Birgitta Jonasson.

Last year Britain announced a phased withdrawal of the drug because of the high risk of overdose and death and the drug's negligible effectiveness. "It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive," the British government stated.

In addition to heart toxicity, popoxyphene is dangerous if prescribed to the elderly because the adverse events related to the central nervous system can increase the likelihood of falls and fall-related fractures in the elderly.

According to previous studies, propoxyphene prescribed widely in the institutionalized population, in emergency rooms and in community-dwelling older people. These populations are particularly vulnerable to the negative effects of propoxyphene.

"The Food the Drug Administration should immediately begin phasing out the use of propoxyphene," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "Millions of people, many of them elderly, are being put at risk when using this drug when there are safer, more effective alternatives available. We agree with the British government's conclusion that the efficacy of this product 'is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable."]]> http://www.yourlawyer.com/articles/read/11417 Tue, 28 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11417
Several hundred more people have died accidentally after taking the drugs each year since then, Public Citizen’s Health Research Group said in a petition it planned to submit to Food and Drug Administration acting Commissioner Dr. Andrew von Eschenbach.

Dr. Sidney Wolfe, the group’s director, said the main active ingredient in the drugs, propoxyphene, is a relatively weak painkiller and poses an unacceptable toxic risk to the millions of patients prescribed it each year. It’s been sold since 1957.

“This a black-and-white example of a drug where its risks far outweigh its benefits,” Wolfe said. “There’s no excuse for this drug to be around.”

The drug’s popularity has waned, but still doctors wrote 23 million prescriptions for propoxyphene-containing drugs last year. Darvocet, which combines propoxyphene with acetaminophen, is among the best known.

An analysis of 26 studies that compared propoxyphene and acetaminophen with just acetaminophen or a dummy pill found the “narcotic combination offered little benefit over acetaminophen alone” in treating pain.

“Thus, propoxyphene provides minimal if any additional analgesia to acetaminophen alone and is associated with significant adverse effects. It cannot be recommended for routine use,” Dr. Carolyn Sachs of the University of California, Los Angeles, wrote in her analysis, published in March 2005 in American Family Physician.

Heart problems

A phase-out, meant to wean users from the drug, and eventual ban would follow a similar decision made in January 2005 by the United Kingdom, Wolfe said. Public Citizen first sought to ban propoxyphene in 1978.

The FDA does not comment on petitions, spokeswoman Laura Alvey said. The regulatory agency has 180 days to respond to petitioners.

Wolfe said Public Citizen may not wait before undertaking legal action to get the drug off the market.

The body transforms propoxyphene into norpropoxyphene, which can build up in the body and is associated with a variety of heart problems, including arrhythmia.

Eli Lilly and Co. developed the drug but later sold it to aaiPharma Inc. of Wilmington, N.C. That company sold Darvon and Darvocet last year to Xanodyne Pharmaceuticals Inc. The Newport, Ky., company did not return a call seeking comment.

Mylan Pharmaceuticals Inc., one of the larger of the dozen-plus manufacturers of generic drugs containing propoxyphene, declined to comment without having seen the petition, spokesman Patrick Fitzgerald said. Two others: Teva Pharmaceuticals USA and Tyco Healthcare/Mallinckrodt did not return calls seeking comment.

Propoxyphene is among the nation’s most widely abused painkillers, Substance Abuse and Mental Health Services Administration spokeswoman Leah Young said. A 2004 survey found 21 million people had made “non-medical” use of products containing propoxyphene or codeine, Young said.]]> http://www.yourlawyer.com/articles/read/9258 Mon, 31 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9258 Co-proxamol, prescribed to hundreds of thousands of Britons every year, is to be the subject of a staggered withdrawal because of evidence that it can cause death if patients exceed the maximum recommended dosage by as little as two tablets.


Up to 400 deaths a year are linked to either accidental or intentional overdoses of co-proxamol, which is normally taken for mild to moderate pain and is similar to paracetamol. A recent study found that the medication, whose effects are increased by alcohol, was responsible for 18 per cent of all drug-related deaths and 5 per cent of all suicides. David Kelly, the Governments weapons adviser, is believed to have taken up to three packets of co-proxamol shortly before his death in 2003.

Last year eight million prescriptions were issued in England and Wales for co-proxamol, which has been a mainstay in British healthcare for more than 40 years.

As recently as 1997 it was the second most prescribed drug, after the antibiotic amoxycilin. It is currently marketed by several pharmaceutical companies as co-proxamol and it is also sold under the brand names Distalgesic, Cosalgesic and Dolgesic.

A number of pharmaceutical giants including Eli Lilly, which produced Distalgesic through its subsidiary company Dista, will be affected by the announcement, which will signal the end of a market worth tens of millions of pounds. However, as the patent on co-proxamol has expired and it is now produced in many cheap generic forms, no single company is likely to suffer crippling financial losses.

Patients on co-proxamol, which is used to treat conditions such as mild back pain and arthitis, are recommended not to take more than eight tablets over a 24-hour period. But the ingestion of as few as ten tablets has been linked to overdose and death, often caused by slowing of the respiratory system, abnormal heart rhythms and cardiac arrest.

Co-proxamol is a combination of paracetamol and dextropropoxyphene (DXP), a narcotic related to methadone. Studies have shown that while it is no more effective as pain relief than paracetamol, the odds of dying after a co-proxamol overdose are 28 times higher.

The Times understands that an announcement on the withdrawal of co-proxamol will be made tomorrow by the Medicines and Healthcare products Regulatory Agency (MHRA), the drugs regulator. It has been the subject of an MHRA risk and benefit review since last June. The MHRA is expected to advise that doctors no longer initiate new prescriptions of the drug. Those patients taking co-proxamol should not stop taking it without consulting their doctor. Instead, the MHRA is likely to advise that they should have their prescription changed at their next doctors appointment.

While the withdrawal is likely to encounter opposition from some doctors whose patients have enjoyed the benefits of co-proxamol for many years, the MHRAs decisive move will have strong support from health professionals concerned at the unnecessary risk.

The action is the latest to be taken against high-profile medicines in recent months, after the withdrawal of the antiarthritis drug Vioxx, which had been shown to double the risk of heart attack and stroke.]]> http://www.yourlawyer.com/topics/overview/darvocet Mon, 31 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/darvocet Injured by Darvocet? Public Citizen’s Health Research Group asked the FDA on February 28, 2006 to ban Darvon and Darvocet, two popular painkillers. Darvon and Darvocet have been associated with the deaths of at least 2,110 people between 1981 and 1999. Additionally, Public Citizen’s Health Research Group said several hundred more people have died accidentally after taking the drugs each year since then. Dr. Sidney Wolfe, the group’s director, said the main active ingredient in the drugs, propoxyphene, is a relatively weak painkiller and poses an unacceptable toxic risk to the millions of patients prescribed it each year. It’s been sold since 1957.  The drug’s popularity has waned, but still doctors wrote 23 million prescriptions for propoxyphene-containing drugs last year.  Darvocet, which combines propoxyphene with acetaminophen, is among the best known of these types of painkillers.

An analysis of 26 studies that compared propoxyphene and acetaminophen with just acetaminophen or a dummy pill found the “narcotic combination offered little benefit over acetaminophen alone” in treating pain.  “Thus, propoxyphene provides minimal if any additional analgesia to acetaminophen alone and is associated with significant adverse effects. It cannot be recommended for routine use,” Dr. Carolyn Sachs of the University of California, Los Angeles, wrote in her analysis, published in March 2005 in American Family Physician.

Co-proxamol, Britain’s most frequently used drug, has been taken off the market due to concerns about the high risk of accidental death from slight overdose and its frequent use in suicides. Co-proxamol is prescribed to hundreds of thousands of people every year has been the subject of a staggered withdrawal because of evidence that it can cause death if patients exceed the maximum recommended dosage by as little as two tablets. As many as 400 deaths a year are linked to either accidental or intentional overdoses of co-proxamol.

A recent study found that the medication, whose effects are increased by alcohol, was responsible for 18 percent of all drug-related deaths and 5 percent of all suicides. As late 1997, it was the second most prescribed drug after the antibiotic amoxycilin. It is currently marketed by several pharmaceutical companies as co-proxamol and it is also sold under the brand names Distalgesic, Cosalgesic and Dolgesic. In the United States the drug is sold under the names Darvocet and Darvon.

If you or a loved one has taken Darvocet and experienced suicidal thoughts or committed suicide, contact us for a free case evaluation about your case today. Please fill out the short form at the right, or call our lawyers at 1-800-LAW-INFO (1-800-529-4636).]]>