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Possible cardiac, psychiatric risks prompt FDA to mandate ADHD medication guides.

The Food and Drug Administration has sent letters to all manufacturers of medications approved for the treatment of attention-deficit hyperactivity disorder, instructing them to develop patient medication guides within 30 days as a way to notify patients of the possible cardiovascular risks and adverse psychiatric symptoms associated with their use.

The ruling builds on regulatory action the FDA took last May, when it directed manufacturers to revise product labeling for physicians to reflect concerns about adverse cardiovascular and psychiatric events based on a review of data by the FDA's Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

"The main reason for having these medication guides is to remind patients and their families of the same things that we're reminding clinicians of," Dr. Tom Laughren, director of the division of psychiatry products at the FDA Center for Drug Evaluation and Research, said during a teleconference. That is, "if you are going to make a decision to use the medication, you need to get a careful history because it's important to know whether or not a patient has some underlying risk factors."

It's also important for patients to let physicians "know about any new symptoms that are emerging during treatment," he said.

Concern about cardiovascular risk comes from an FDA review of spontaneous reports of sudden unexplained death in patients taking usual doses of ADHD products, "many of those occurring in patients who turned out to have underlying cardiac defects," Dr. Laughren said.

"There were also reports of strokes and heart attacks, again generally in patients with underlying risk factors for those events," he added.

Concern about adverse psychiatric events, principally psychotic symptoms, comes from another FDA review, including spontaneous reports and pooled analyses of placebo-controlled trials.

"The causal link is stronger for this event than it is for cardiovascular events," Dr. Laughren said, noting that that adverse psychiatric events occur in about in 1 of every 1,000 patients treated.

He emphasized that despite a call for new warning language in the patient medication guides, he and his associates at the FDA "continue to view ADHD as an important illness that benefits from treatment from this class of medications. We are not in any way discouraging appropriate treatment of patients with these medications. Rather, we want prescribers and patients to be aware of certain risks that might be associated with these treatments in some patients, so that appropriate information can be collected and patients can be safely treated."

The ruling will require the following 15 products to be dispensed with new patient medication guides: Adderall tablets, Adderall XR extended-release capsules, Concerta extended-release tablets, Daytrana transdermal system, Desoxyn tablets, Dexedrine Spansule capsules and tablets, Focalin tablets, Fo-calin XR extended-release capsules, Metadate CD extended-release capsules, Methylin oral solution, Methylin chew-able tablets, Ritalin tablets, Ritalin SR sustained-release tablets, Ritalin LA extended-release capsules, and Strattera capsules.

Draft medication guides for each ADHD product can be found at


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Author:Brunk, Doug
Publication:Clinical Psychiatry News
Geographic Code:1USA
Date:Mar 1, 2007
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