http://www.newsinferno.com/archives/823
FDA Advisory Committee Recommends Black Box Warning for Ritalin, Adderall, Concerta, and Other ADHD Drugs for Potential Risk of Heart Attacks, Strokes, and Sudden Death
In what many experts are viewing as an unusual turn of events, an FDA advisory panel has voted 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.
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 panels 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 panels 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 panels 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 FDAs 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.
This entry was posted on Friday, February 10th, 2006 at 8:36 am and is filed under Legal News, Drug Side Effects, Health Concerns.
http://www.suntimes.com/output/health/cst-nws-rit10.html
FDA advisers: Beef up Ritalin warning label
February 10, 2006
WASHINGTON -- Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said Thursday.
The Food and Drug Administration advisory panel voted for the warning on cardiovascular risks after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention. The FDA isn't required to follow panel recommendations but usually does.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month.
AP
http://www.nytimes.com/2006/02/09/health/09cnd-drug.html
.D.A. Panel Urges Warnings on Ritalin and Other Stimulants
By GARDINER HARRIS Published: February 9, 2006
GAITHERSBURG, Md., Feb. 9 Stimulants like Ritalin could have dangerous effects on the heart, and federal drug regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal drug advisory panel voted today.
The votes could have profound effects on the nearly four million patients taking the drugs, and they promise to intensify a long-running debate about whether the drugs are being overused. Members of the Food and Drug Administration advisory committee said that they wanted to stop the explosive growth in the use of the drugs, particularly in adults.
"I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who is a panel member.
F.D.A. officials said that they would do nothing immediately to change the drugs' labels and suggested that they are unlikely to follow the committee's advice any time soon.
"We don't think anything different needs to be done right now," Dr. Thomas Laughren, director of the F.D.A.'s division of psychiatric drugs, said at a hastily arranged news conference after the meeting. "We think the labeling right now is adequate."
The advisory committee voted unanimously to recommend patient guides, and it voted 8-to-7 to suggest that stimulant labels carry the most serious of the Food and Drug Administration's drug-risk warnings something called a "black box."
Arthur Levin, director of the Center for Medical Consumers in New York City and a member of the panel, said patients assume that stimulants are safe. That confidence is misplaced, he said.
"For us to sit around and talk about it and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks would be unethical," Mr. Levin said.
Dr. Thomas Fleming, a professor of biostatics at the University of Washington and another panel member, said stimulants may be far more dangerous to the heart than Vioxx or Bextra, two drugs that were withdrawn because of their ill effects on the heart.
Another advisory committee, this one packed with pediatricians and psychiatrists, will be asked next month to weigh the same issues, and that committee is likely to come to a very different conclusion.
Today's committee was made up largely of drug-safety specialists, who tend to focus on drug risks. Clinicians, like those who make up next month's panel, tend to focus on drug benefits and oppose increased warnings that might limit access to medicines.
The vote by the drug-risk panel also grew out of changing ideas about what to do in the face of uncertainty. For decades, the F.D.A. generally refused to warn doctors about what is unknown about medicines, even when there were hints of dangers. Today's committee said that such silence when millions take the drugs is a mistake.
"Put yourself in our shoes," said Dr. Peter A. Gross, the panel's chairman and chairman of the department of internal medicine at Hackensack University Medical Center. "Most of us see our role as protecting the public health. As often happens, the data we would like to see is not clear. In that setting, what we would like to see is a clearer warning."
Top F.D.A. officials said that warning patients about a theoretical risk might scare many away from needed treatment.
"We still believe that what you tell people should reflect the available data," said Dr. Robert Temple, director of the agency's office of medical policy. "We didn't find the sudden death data very persuasive."
The Food and Drug Administration had brought the committee to a hotel just outside of Washington solely to discuss ways to research the possible heart risks of the drugs. But after reviewing a preliminary analysis of millions of health records that found that stimulants may significantly increase the risks of strokes and serious arrhythmias in children and adults, committee members said the F.D.A. needed to warn patients and clinicians immediately about the potential risks of the drugs.
"I want to cause people's hands to tremble a little bit before they write that prescriptions," Dr. Nissen said.
The study is not definitive, said Dr. David Graham, a medical officer in the Food and Drug Administration's office of drug safety. But combined with reports of at least 25 deaths among children and adults taking the drugs from 1999 to 2003, agency officials told a panel of independent experts today that they were increasingly concerned about the safety of stimulants.
"The number of arrhythmia hospitalizations really struck us as surprising," Dr. Graham said. "Arrhythmia is believed to be the pathway for sudden unexplained death."
In an interview after his presentation, Dr. Graham said, "There's smoke. Does that represent a fire? We want to answer that question."
Stimulants are now the most widely prescribed medicine for childhood behavioral problems. Dr. Andrew Mosholder, an F.D.A. medical officer in the agency's office of drug safety, told the committee that somewhere from twp million to four million children in the United States are taking stimulants in any given month.
Of perhaps even greater concern is the drugs' growing use in adults, F.D.A. officials said. Adults already have high rates of heart disease, so even a small increase in heart risks from stimulant use could lead to huge numbers of additional deaths, Dr. Graham said.