THURSDAY, Feb. 9, 2006 (HealthDay News) -- A U.S. advisory panel recommended on Thursday the strongest possible label warning for Ritalin and other stimulants used to treat attention-deficit hyperactivity disorder because of potential cardiac risks.
The Food and Drug Administration advisory committee voted 8-7, with one abstention, to add a "black box" warning to the drugs, which include methylphenidates such as Ritalin, Concerta, Methylin and Metadate. Amphetamines, including Adderall, are also commonly used for the disorder. In August 2004, the FDA added a warning to Adderall, telling patients with heart conditions not to use the drug.
The recommendation came after reports of the deaths of 25 people, 19 of them children, among people using both types of medications.
The FDA usually, but not always, follows the recommendations of its advisory committees. This instance was unusual, however, because the committee was originally charged only with discussing whether further studies were feasible and necessary.
"It doesn't astonish me that the committee wanted to weigh in on the virtues of revising the labeling, but that is not the primary matter we went to them for," said Dr. Robert Temple, director of the FDA's Office of Medical Policy. "We're going to consider what this committee said."
"You don't want to overscare people with data that isn't very solid," he continued. "We're going to be weighing all those things, and I can't give you an answer yet."
About 2 million children and 1 million adults are prescribed medications for attention-deficit hyperactivity disorder (ADHD) each month. Adult use of the drugs grew 90 percent between March 2002 and June 2005, according to the FDA.
Committee member Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, characterized this explosion in adult use as "out of control growth," the Associated Press reported. Nissen was in favor of a black-box warning.
The spiraling growth in use of the medicines has spurred both scrutiny and controversy. One drug, Strattera, is now required to carry a black-box warning that it may prompt suicidal thoughts in children. Last year, Health Canada briefly pulled Adderall from the market. And, in July 2005, an FDA advisory committee considered, but rejected, labeling changes for Ritalin, Metadate and other methylphenidates, a class of stimulants. The panel also suggested that changes to Adderall and Strattera be delayed until more safety data was collected.
Thursday's meeting was prompted by reports of 25 deaths and 54 cases of serious cardiovascular problems in adults and children between 1999 and 2003.
An earlier FDA review found less than one death or serious injury per 1 million ADHD drug prescriptions filled. In the case of nonfatal cardiovascular or cerebrovascular problem, the number was 1.79 cases per 1 million in adults treated with amphetamines.
The agency said it found an additional 26 deaths between 1969 and 2003.
At a news conference held late Thursday, FDA officials seemed reluctant to embrace the committee's recommendations.
"I think it's important not to minimize the benefits of these drugs," said Dr. Thomas Laughren, director of the division of psychiatry products at the FDA's Center for Drug Evaluation and Research. "We put a black box on antidepressants for adolescents, but it did have an impact on prescribing and there's been a lot of negative feedback from the clinical community. It's important to recognize that something as dramatic as a black box can have a dramatic effect on prescribing."
"It's clear that we are going to tell people about things at a lower degree of uncertainty than we have in the past, but there's still a threshold," Temple added. "We still believe what we tell people should reflect data... We didn't find the sudden death data very persuasive. Having said that, other things are reasonably persuasive."
One reasonably persuasive finding was the affect of the drugs on people with heart failure, Temple noted.
Clinicians seemed to agree with the FDA official's assessment.
"You have to look at the cost-benefit ratio," said Dr. Jon A. Shaw, director of child and adolescent psychiatry at the University of Miami School of Medicine. "ADHD is probably the most common psychiatric diagnosis in school-aged children. It's a real medical condition, and it's associated with neurobiological chemical aberrations. Hundreds of studies have shown that psychosocial stimulants improve academic performance, social behavior, relationships."
"Nothing is chicken soup except chicken soup," added Dr. Karen Ballaban-Gil, a professor of clinical neurology and clinical pediatrics at Albert Einstein College of Medicine and Montefiore Medical Center in New York City. "We use medication because, at times, we have no choice. There is a low, but not zero, risk to these drugs and it's felt that, in the majority of the cases, the benefit outweighs the risk. If we had an alternative to medication that did not have side effects and had an equally good outcome that would be wonderful, but it doesn't exist."
Many of the issues will be revisited when another advisory committee meets in March.
More information
Visit the U.S. Food and Drug Administration for more on this advisory committee meeting.
