Drug Guides Required For All Approved ADHD Medications

The FDA is requiring drug guides for all medications approved to treat ADHD. The guides are for use by patients, families and caregivers, and will carry information about the cardiovascular and psychiatric risks of the drugs. In May 2006, the FDA ordered revision of the labeling for ADHD drugs to address concerns about the risks of adverse cardiovascular and psychiatric symptoms. There have been reports of sudden death in patients taking ADHD drugs with underlying cardiac problems. Strokes and heart attacks have also been reported in adults with cardiac risk factors. The psychiatric adverse events associated with the use of ADHD drugs include paranoia, auditory hallucinations and manic episodes. The following products have revised labeling and will have the patient drug guides: Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate, Methylin, Ritalin, Ritalin SR, Ritalin LA and Strattera.