FDA Directs ADHD Drug Manufacturers to Notify Patients About Cardiovascular and Mental Dangers
The U.S. Food and Drug Administration (FDA) has directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients that possible cardiovascular risks and adverse mental symptoms are associated with the medicines. The Guides are intended 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 heart 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.
ADHD is an alleged condition that is said to affect 3 to 7 percent of school-aged children and approximately 4 percent of adults. There is no scientific research actually proving the existence of ADHD as an actual disease or condition. The three main symptoms are inattention, hyperactivity, and impulsivity. People labeled as suffering from ADHD may have difficulty in school, troubled relationships and low self-esteem.
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.
The medicines that are the focus of the directive 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) 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