http://www.yourlawyer.com/topics/overview/metadate Sat, 21 Nov 2009 03:25:08 -0800 pixel-app en http://www.yourlawyer.com/articles/read/12595 Fri, 23 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12595
The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and chewable versions.

The panels made the recommendation after reviewing reports of young children hearing voices or having hallucinations while on the medications, some reporting they could see snakes or bugs or worms, and there were other reports of heart complications, including sudden death.

An agency review found a slightly increased risk, about one per 1,000 patients for adverse psychiatric reactions. A separate review of reports of serious cardiovascular adverse events found reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

The new patient guides would supplement the information already included on the drugs' labeling and would be given out in booklet or pamphlet form with each prescription.

Dr. Mark Epstein, a specialist in the treatment of ADHD and medical director of the Miami Children's Hospital Dan Marino Center in Weston, Fla., said the concerns first surfaced about two years ago and that he got calls from many parents of his patients who take the drugs.

"Parents are very scared when they hear about a risk for sudden death," Epstein said. But after he explained that the risk is no higher for children on the drugs than for the general population, and that the deaths occurred in patients with known heart problems or a family history of such problems, only one or two parents insisted their children be taken off the drugs, he said.

"When the appropriate diagnosis is made and the medications are prescribed properly, they are exceedingly safe," Epstein said, but he recommended that patients and parents talk with their own doctors if they have concerns.

ADHD affects an estimated 3 percent to 7 percent of school-age children and about 4 percent of adults. The three main symptoms are inattention, hyperactivity and impulsivity.]]> http://www.yourlawyer.com/articles/read/12584 Thu, 22 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12584
Patients would receive with their prescriptions two-page "medication guides" that warn about possible side effects and urge them to notify doctors immediately after any sign of heart or psychiatric problems, such as chest pain, shortness of breath, fainting or hallucinations.

Dr. Thomas Laughren of the Food and Drug Administration emphasized that the move was precautionary and should not frighten patients away from taking the drugs, which he said were safe. He expected the manufacturers of the 15 drugs to comply with the request within 30 days.

An estimated 3.3 million children and 1.5 million adults take ADHD drugs, whose sales exceed $3.5 billion a year. Their use has been dogged by concerns about overuse in children and side effects, prompted by scattered reports of children dying suddenly. Some of the children were later determined to have had heart defects.

The latest action expands upon a move the government made last year, when the FDA asked manufacturers to revise ADHD drug labels to alert prospective patients with heart problems and warn of hallucinations in one out of 1,000 children.

Dr. Richard L. Gorman, a pediatrician who served on an FDA advisory panel that recommended the ADHD drug warnings, said the medication guides were "in line with" what the committee recommended. Gorman said parents must pay close attention to their children's reactions to the drugs because children might take them for years.

Laughren said it took until now to work out the wording of the medication guides, which are more simply worded than drug labels. Companies may tweak the language that the FDA proposed, he added.

More than 2,500 children who took ADHD drugs went to emergency rooms in 2004, and about a quarter of them had serious heart or blood pressure problems, the Centers for Disease Control and Prevention reported last year. Twenty-five deaths, 19 involving children, linked to the drugs were reported to the FDA from 1999 to 2003. Fifty-four strokes, heart attacks and other heart issues were also reported; some of those patients had previous heart conditions.]]> http://www.yourlawyer.com/articles/read/12580 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12580
The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday's announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.]]> http://www.yourlawyer.com/articles/read/12581 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12581
The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.]]> http://www.yourlawyer.com/articles/read/12582 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12582
“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research (CDER). “In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns.”

According to the agency, “An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.”

In May of 2006, the FDA’s Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee directed the drug makers to revise their label warnings, and the new directive for Patient Medication Guides is the next step in that process. There are 15 medications subject to the new warnings: Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin Oral Solution, Methylin Chewable Tablets, Ritalin, Ritalin SR, Ritalin LA, and Strattera.

The FDA says that approximately 3 percent to 7 percent of children and 4 percent of adults suffer from ADHD, which has three main symptoms: inattention, hyperactivity, and impulsivity. They recommend that any patient considering using any of these drugs “develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).”

According to drafts of the medication guides posted on the FDA’s website, the warnings include information about adverse events including “heart-related problems” and “mental (psychiatric) problems.” The heart-related problems cited include sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; and increased blood pressure and heart rate. The psychiatric problems facing all patients include new or worse behavior and thought problems; new or worse bipolar illness; and new or worse aggressive behavior or hostility. For children and teenagers, there are added warnings about new psychotic symptoms (such as hearing voices, believing things that are not true, unfounded suspicion) or new manic symptoms.]]> http://www.yourlawyer.com/articles/read/12585 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12585
Tom Laughren, director of the FDA's Division of Psychiatry Products, said makers of the 15 products approved to treat ADHD have 30 days to finalize the language in the medication guides. Meanwhile, drafts written by the FDA are posted online at www.fda.gov/cder/drug/ infopage/ADHD/default.htm.

About 3% to 7% of school-age children and about 4% of adults have attention disorders, the FDA says. In 2006, U.S. sales of ADHD drugs totaled about $3.5 billion, according to IMS Health, a health care information company.

Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.

From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.

In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.

Also, a pooled analysis of trials that compared an ADHD drug with a placebo found a higher rate of hallucinations, delusions and mania in patients who were given the medication, Laughren said, putting the risk for such problems at one in 1,000 patients.

"Despite this new warning language in the medication guides; we continue to view ADHD as an important illness that benefits from treatment," Laughren said.]]> http://www.yourlawyer.com/articles/read/12594 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12594
"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

• Adderall (mixed salts of a single entity amphetamine product) Tablets
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine HCl) Tablets
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine HCl) Capsules

]]> http://www.yourlawyer.com/articles/read/11374 Tue, 21 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11374
On September 28, 2005 for example, Lilly declared it was adding a black-box warning to Strattera. That warning advises that the drug may increase suicidal thoughts among youths. 

FDA officials said Eli Lilly must also create a medication guide for patients and healthcare providers pertaining to the new black box warning. Black box warnings are the most prominent and serious of medication warnings.

The FDA said Lilly submitted results from a Strattera clinical trial of 1,357 youths taking the medication that found five of them had increased suicidal thoughts, while none of 851 youths taking a placebo showed such changes. Lilly said one youth attempted suicide during its Strattera trials, but that researchers saw no signs of increased suicidal thoughts among adults.

Strattera has also been linked to liver problems. In 2004, Lilly warned doctors to stop prescribing Strattera in patients with jaundice or who show signs of liver damage.

Lilly warned that Strattera can cause severe drug related liver injury that can progress to acute liver failure resulting in death or the need for a liver transplant. In December 2004 the FDA updated Strattera's label to include the serious liver side effects.

In December of last year, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said the federal government requested Lilly to assess 13 clinical trials conducted on children to measure a suicide risk.

"The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four (case) per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug," Laughren said.

In June 2005, the FDA announced it will be investigating all attention deficit hyperactivity disorder drugs including Strattera, Ritalin, Concerta, and Adderall in response to reports of serious psychiatric side effects in patients taking Concerta and Ritalin. Some ADHD drugs are also associated with cardiovascular side effects.

In what many experts are viewing as an unusual turn of events, an FDA advisory panel, in January of this year, voted (8-7-1) to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and sudden death. The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin, and Metadate.

The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents.
This new controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children.

In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency on how to design studies to assess possible risks associated with stimulant ADHD medications. (Adderall is the only non-stimulant ADD drug).

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.
The FDA has attempted to back off from the unexpected action by the panel by issuing a statement that it would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research. He stated: "The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm."

Thus, Temple indicated the full FDA would wait for the recommendation of a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks. 

Now comes word that Strattera is faring no better in the UK in light of these safety concerns well as the possibility that the drug is also associated with seizures and a potentially dangerous lengthening of the interval between heartbeats.

According to IndyStar.com, the Tacoma (Washington) News Tribune, and Reuters, the “warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency. The report, which has not been made readily available to the public, was obtained by The News Tribune after a Swedish court ordered it released in that country.

“Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and it warned doctors and consumers that the drug should be used with caution in people prone to such problems.

“In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.”
Although British authorities still believe the drug’s benefits outweigh its risks, they are updating the drug's label in that country to warn of the possible problems. Presently, no warnings regarding the seizure risk are contained in the U.S. labeling. The heart problem risk, however, was inserted in the 25-page U.S. label in January at the request of the FDA.]]> http://www.yourlawyer.com/articles/read/11331 Fri, 10 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11331
What makes this action (by an 8-7-1) vote surprising to critics of what they see as an influence-riddled agency beholden to the pharmaceutical industry and a system that “rubber stamps” the fully-expected recommendations of supposedly independent panels is that the FDA is now faced with a vote that is clearly against the best interests of the drug companies.

Thus, rather than having a “safe” vote that the agency can simply endorse as its position on a drug, the FDA is already expressing its view of the vote in terms that strongly suggest it may not adopt the panel’s carefully considered recommendation. This has done little more than throw fuel on an already blazing fire.

The panel also voted 15-0-1 to recommend that the FDA require  that the drugs include a medication guide for patients and parents. All of this controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children. In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency  on how to design studies to assess possible risks associated with stimulant ADHD medications.

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.

In attempting to lay the foundation for ignoring the panel’s vote, officials said they would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research. He stated: "The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm."

Thus, Temple indicated the full FDA would wait for the recommendation a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks.]]> http://www.yourlawyer.com/topics/overview/metadate Fri, 10 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/metadate Injured by Metadate? Black Box Warning Recommended
On February 9, 2006, an FDA panel voted to recommend a black box warning for Metadate and other drugs prescribed to treat attention deficit hyperactivity disorder (ADHD or ADD).  The Food and Drug Administration scientific committee voted 8-7 to add a black box warning, the agency's strongest, to the labels of five drugs in the class including Metadate, Methylin, Ritalin, Concerta and Adderall.

Deaths Reported to the FDA
The FDA had requested a review by the panel to evaluate ways of studying the ADHD drugs because of its data suggesting a link between the drugs and the risk of sudden death and serious cardiovascular problems including heart attacks, stroke, hypertension, palpitations and arrhythmia.  The agency reported 25 deaths between 1999 and 2003 which may be related to the ADHD drugs included in the warning.  Nineteen of the 25 deaths were children.  There were 54 cases of serious cardiovascular problems reported in children and adults.

About Metadate
Metadate CD is a reformulation of Ritalin for extended delivery over several hours.  It comes in 10 and 20 mg tablets and delivers a small, steady dose throughout the day. The active ingredient, methylphenidate, is reported to have serious cardiovascular side effects including cardiac arrhythmia, tachycardia, chest pain and hypertension.  Reported psychiatric side effects of methylphenidate include suicidal thoughts, aggression, psychotic behavior and hallucinations.

Legal Help for Metadate Victims
If you or a loved one took Metadate and experienced cardiovascular side effects, sudden death, or psychiatric side effects, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney.]]>