The FDA today directed manufacturers of all drugs approved to treat attention deficit hyperactivity disorder (ADHD) to develop patient medication guides to warn patients about cardiovascular and psychiatric risks associated with the medicines, including sudden death.
The directive follows an FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products. The review also revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors, the FDA said in a news release issued today.
Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.
The FDA recommended that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).
The medicines that are the focus of the revised labeling and new patient medication guides include the following 15 products:
*Adderall (mixed salts of a single entity amphetamine product) tablets
*Adderall XR (mixed salts of a single entity amphetamine product) extended-release capsules
*Concerta (methylphenidate hydrochloride) extended-release tablets
*Daytrana (methylphenidate) transdermal system
*Desoxyn (methamphetamine HCl) tablets
*Dexedrine (dextroamphetamine sulfate) spansule capsules and tablets
*Focalin (dexmethylphenidate hydrochloride) tablets
*Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules
*Metadate CD (methylphenidate hydrochloride) extended-release capsules
*Methylin (methylphenidate hydrochloride) oral solution
*Methylin (methylphenidate hydrochloride) chewable tablets
*Ritalin (methylphenidate hydrochloride) tablets
*Ritalin SR (methylphenidate hydrochloride) sustained-release tablets
*Ritalin LA (methylphenidate hydrochloride) extended-release capsules
*Strattera (atomoxetine HCl) capsules
ADHD affects approximately 3% to 7% of school-aged children and approximately 4% of adults, according to the FDA.
Sales of ADHD drugs in 2005 hit $3.04 billion.
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