adhd drugs
Posted: Fri Feb 10, 2006 9:55 pm
FDA panel: Put most serious 'black box' warnings on some ADHD drugs
04:44 PM PST on Thursday, February 9, 2006
Associated Press
KING
Ritalin is one of the commonly prescribed drugs for ADHD.
WASHINGTON - A black box label on a medication is the most severe warning of potential safety risks. The stimulants that millions of children and adults in the U.S. now take for attention deficit hyperactivity disorder may soon carry one.
After hearing about 25 deaths among people taking the drugs, federal health advisers recommended Thursday that such a warning be added to labels on Ritalin and other methylphenidates, which include Concerta, Methylin and Metadate.
The stimulant Adderall, an amphetamine, has included the warning since 2004.
The Food and Drug Administration is not required to follow the recommendations of its advisers but usually does.
The FDA said it had evidence suggesting the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks. But, officials said, they wanted to see the results of further studies before taking regulatory action.
The FDA originally asked its Drug Safety and Risk Management advisory committee to examine ways of designing those studies. The committee, in a quick and unexpected move, decided to examine the issue of warning labels.
One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to warn people that there was uncertainty about the safety of the drugs.
An 8-7 vote to recommend requiring the warnings soon followed, on the heels of a 15-0 vote to recommend the drugs include a medication guide for patients and parents. There was one abstention on each vote.
Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, introduced the two motions. Nissen said they were meant partly to slow what he characterized as the "out of control growth" use of the increasingly popular drugs.
Dr. Robert Temple, director of the FDA's Office of Medical Policy, said the agency would consider the panel's recommendation.
"The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Temple said.
A different advisory committee is scheduled to take up the labeling issue next month, he said.
The FDA convened the meeting after it uncovered reports of deaths of 25 people, including 19 children, who had taken the ADHD drugs in its databases.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month. The reports of death or injury amounted, with one exception, to fewer than one case per million prescriptions written.
"The decision has been apparently made, and if it's been made, I agree with it, that the reports are not enough to warrant regulatory action," committee member Sean Hennessy said.
Hennessy, an assistant professor of epidemiology and pharmacology at the University of Pennsylvania School of Medicine, ended up voting against recommending the black box warning.
Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Various other companies make generic versions of Ritalin.
Novartis said Ritalin, approved by the FDA in 1955, is safe and effective. A company review of more than 50 years of records shows no apparent increase in cardiovascular problems associated with the drug's use, according to Novartis' medical safety director, Dr. Todd Gruber.
The black box warning would not apply to Strattera, made by Eli Lilly and Co. That drug is not a stimulant.
Dr. Gerald Dal Pan, a division director in the FDA's Center for Drug Evaluation and Research, said the drugs already carry warnings related to the possible risk they could pose to patients with heart defects.
"We feel this warning is appropriate given our current knowledge of these drugs," Dal Pan said before the votes.
The FDA review also uncovered 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia. Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension.
"There's smoke. Does that mean there's fire?" asked Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research.
"We wouldn't be going through this exercise if we didn't think there was a real possibility of increased risk," Graham told reporters.
The FDA said the few studies that have looked at longer-term use of ADHD drugs provide little information on those risks.
Also, the agency's analysis of the reports of death and injury only suggests a possible link between the drugs and cardiovascular problems, said Dr. Kate Gelperin, a medical officer in the agency's Office of Drug Safety.
Sales of ADHD drugs rose to $3.1 billion in 2004 from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.
Adult use of the drugs alone grew 90 percent between March 2002 and June 2005, according to the FDA.
"Because adults have a higher risk of heart disease and stroke to begin with, any increase in risk caused by these drugs could affect a large number of people," the FDA's Graham said.
Committee member Robyn Shapiro, a professor of bioethics at the Medical College of Wisconsin, said any discussion of the drugs should include talk of their benefits as well.
--------------------------------------------------------------------------------
Online at: http://www.king5.com/health/stories/NW_ ... 48a3b.html
04:44 PM PST on Thursday, February 9, 2006
Associated Press
KING
Ritalin is one of the commonly prescribed drugs for ADHD.
WASHINGTON - A black box label on a medication is the most severe warning of potential safety risks. The stimulants that millions of children and adults in the U.S. now take for attention deficit hyperactivity disorder may soon carry one.
After hearing about 25 deaths among people taking the drugs, federal health advisers recommended Thursday that such a warning be added to labels on Ritalin and other methylphenidates, which include Concerta, Methylin and Metadate.
The stimulant Adderall, an amphetamine, has included the warning since 2004.
The Food and Drug Administration is not required to follow the recommendations of its advisers but usually does.
The FDA said it had evidence suggesting the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks. But, officials said, they wanted to see the results of further studies before taking regulatory action.
The FDA originally asked its Drug Safety and Risk Management advisory committee to examine ways of designing those studies. The committee, in a quick and unexpected move, decided to examine the issue of warning labels.
One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to warn people that there was uncertainty about the safety of the drugs.
An 8-7 vote to recommend requiring the warnings soon followed, on the heels of a 15-0 vote to recommend the drugs include a medication guide for patients and parents. There was one abstention on each vote.
Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, introduced the two motions. Nissen said they were meant partly to slow what he characterized as the "out of control growth" use of the increasingly popular drugs.
Dr. Robert Temple, director of the FDA's Office of Medical Policy, said the agency would consider the panel's recommendation.
"The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Temple said.
A different advisory committee is scheduled to take up the labeling issue next month, he said.
The FDA convened the meeting after it uncovered reports of deaths of 25 people, including 19 children, who had taken the ADHD drugs in its databases.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month. The reports of death or injury amounted, with one exception, to fewer than one case per million prescriptions written.
"The decision has been apparently made, and if it's been made, I agree with it, that the reports are not enough to warrant regulatory action," committee member Sean Hennessy said.
Hennessy, an assistant professor of epidemiology and pharmacology at the University of Pennsylvania School of Medicine, ended up voting against recommending the black box warning.
Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Various other companies make generic versions of Ritalin.
Novartis said Ritalin, approved by the FDA in 1955, is safe and effective. A company review of more than 50 years of records shows no apparent increase in cardiovascular problems associated with the drug's use, according to Novartis' medical safety director, Dr. Todd Gruber.
The black box warning would not apply to Strattera, made by Eli Lilly and Co. That drug is not a stimulant.
Dr. Gerald Dal Pan, a division director in the FDA's Center for Drug Evaluation and Research, said the drugs already carry warnings related to the possible risk they could pose to patients with heart defects.
"We feel this warning is appropriate given our current knowledge of these drugs," Dal Pan said before the votes.
The FDA review also uncovered 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia. Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension.
"There's smoke. Does that mean there's fire?" asked Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research.
"We wouldn't be going through this exercise if we didn't think there was a real possibility of increased risk," Graham told reporters.
The FDA said the few studies that have looked at longer-term use of ADHD drugs provide little information on those risks.
Also, the agency's analysis of the reports of death and injury only suggests a possible link between the drugs and cardiovascular problems, said Dr. Kate Gelperin, a medical officer in the agency's Office of Drug Safety.
Sales of ADHD drugs rose to $3.1 billion in 2004 from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.
Adult use of the drugs alone grew 90 percent between March 2002 and June 2005, according to the FDA.
"Because adults have a higher risk of heart disease and stroke to begin with, any increase in risk caused by these drugs could affect a large number of people," the FDA's Graham said.
Committee member Robyn Shapiro, a professor of bioethics at the Medical College of Wisconsin, said any discussion of the drugs should include talk of their benefits as well.
--------------------------------------------------------------------------------
Online at: http://www.king5.com/health/stories/NW_ ... 48a3b.html