“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 an increased risk  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 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