ADHD Stimulant medications increase stroke and heart attack risks and risks of adverse mental symptoms. On February 21, 2007, the FDA directed the manufacturers of all ADHD stimulant medications approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.
An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious health problems or defects, and reports of stroke and heart attack in adults with certain risk factors.
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 recommends 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).
As part of the Agencyâ€™s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events.
These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.
The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:
â€¢ Adderall (mixed salts of a single entity amphetamine product) Tablets
â€¢ Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
â€¢ Concerta (methylphenidate hydrochloride) Extended-Release Tablets
â€¢ Daytrana (methylphenidate) Transdermal System
â€¢ Desoxyn (methamphetamine HCl) Tablets
â€¢ Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
â€¢ Focalin (dexmethylphenidate hydrochloride) Tablets
â€¢ Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
â€¢ Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
â€¢ Methylin (methylphenidate hydrochloride) Oral Solution
â€¢ Methylin (methylphenidate hydrochloride) Chewable Tablets
â€¢ Ritalin (methylphenidate hydrochloride) Tablets
â€¢ Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
â€¢ Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
â€¢ Strattera (atomoxetine HCl) Capsules
FDA News – ADHD Medications and Cardiovascular, Psychiatric Adverse Events – Accessed 1 March 2008.
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