Cardiovascular and Psychiatric Risks with ADHD Drugs

Patients with Attention Deficit Hyperactivity Disorder(ADHD) who are taking stimulant drugs such as Adderall (amphetamine-dextroamphetamine), Ritalin (methylphenidate) and Strattera (atomoxetine hydrochloride) will soon be given a Patient Medication Guide each time the prescription is filled. The medication guide will warn that there have been reports of sudden death in children and adolescents with pre-existing structural cardiac abnormalities or other serious heart problems who were taking stimulant drugs to treat their ADHD. Sudden death, stroke and MI have also been reported in adults with underlying risk factors for these events who took ADHD drugs. The causative role of the stimulants is not clear because pre-existing heart problems themselves carry an increased risk of sudden death. Nevertheless, patients with known serious cardiac problems should generally not use stimulant drugs. The medication guide will also warn about a slight increased risk for drug-related psychiatric adverse events, such as hearing voices, paranoia or mania, even in patients who did not have previous psychiatric problems. FDA recommends that patients who may be treated with these drugs work with their health care provider to develop a treatment plan that includes a careful health and family history, and an evaluation of current health status, especially for cardiovascular and psychiatric conditions. Patients should contact a doctor promptly if symptoms develop that are suggestive of heart disease, or of new or worsening psychiatric problems. ADHD Drugs: • Adderall (mixed salts of a single entity amphetamine product) Tablets • Adderall XR (mixed salts of a single entity amphetamine product) • 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) • Metadate CD(methylphenidate hydrochloride) • 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 FDA Patient Safety News: May 2007 For more information, please see our website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=63#5

Google Video | May 7, 2007

Tags:. .abnormalities. .adhd. .adolescents. .adverse. .amphetamine