FDA Warning on AD/HD Medications "Premature";National AD/HD Advocacy Group Urges Further Research

Contact:
Bryan Goodman
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Fax: (301)306-7090

February 15, 2006 – CHADD, the nation's leading advocacy and family support organization representing people with attention-deficit/hyperactivity disorder (AD/HD), responded with concern to last week’s recommendation by an FDA Advisory committee that warning language be included on AD/HD medication labels.

The nation's largest patient education group, CHADD represents more than 15,000 people affected by AD/HD and provides consumer, patient, professional and organizational information and support and manages the National Resource Center on AD/HD, funded by the U.S. Centers for Disease Control and Prevention.

"The committee's recommendation to include warning language about rare and unproven cardiac health risks on medications used to treat AD/HD is premature, at best, and could unnecessarily alarm patients and clinicians," said E. Clarke Ross, D.P.A., CEO of CHADD, a Landover, MD based advocacy and support group.

"As an organization that relies on scientific research and evidence-based treatment for this disorder, CHADD views the committee’s recommendation as unwarranted and unnecessarily alarming for physicians and patients alike," he said.
On Thursday, February 9 the FDA Drug Safety and Risk Management Advisory Committee voted 8-7 with one abstention to recommend “black box” warnings about possible risk of heart attacks, strokes and sudden death.

No conclusive link between the medications and such health problems has been found, a point underscored by testimony offered by a medical officer in the FDA Office of Drug Safety. Kate Gelperin, M.D., M.P.H., testified that the agency's own studies found no definitive relationship between the medications and the reported incidents in children and adults.

The committee, directed by the FDA to decide how to move ahead with additional research on the medication's safety, endorsed future studies, trials and surveys for both pediatric and adult patients, and then approved the unsolicited recommendation to include warning language on patient inserts and labels.

"We absolutely support the need for further research," Dr. Ross said. "But by recommending warning language without first studying the issue, the committee has sent doctors and their patients an alarming message that is not supported by science."

The organization urged patients to consult with their prescribing clinicians if they had questions about the safety of their medications; people taking medications were advised not to discontinue those treatments without first communicating with their doctors.

The FDA's review of reports of sudden death or cardiovascular incidents in patients taking AD/HD medications found 25 reports of death between 1999 and 2005 and 54 incidents of serious cardiovascular problems. Some of these patients had pre-existing heart conditions or hypertension, the report noted.

For many persons, AD/HD medications are an important part of a comprehensive treatment program that may include patient education, behavior management techniques, medication and school programming and support, with treatment tailored to the unique needs of the individual. According to a December 1999 report from the Surgeon General, medication is effective for about 80 percent of people who have the disorder.

About 2.5 million children between the ages of 4 and 17 take AD/HD medications, according to CDC data. Millions of children and adults have successfully used these medications in recent years, and the many positive benefits, as demonstrated in dozens of studies, speak for themselves. All medications can cause side-effects, and CHADD encourages individuals to share concerns and preexisting conditions with their health care providers. A comprehensive medical examination should always be completed prior to a diagnosis of AD/HD and the selection of treatment options.

See what other mental health organizations are saying about this issue:

The American Psychiatric Association: http://www.psych.org/

The American Academy of Child & Adolescent Psychiatry: http://www.aacap.org/

FAQs about the FDA hearings