The Food and Drug Administration has sent letters to all manufacturers of medications approved for treating attention-deficit hyperactivity disorder, instructing them to develop patient medication guides within 30 days to address possible cardiovascular risks and adverse psychiatric symptoms associated with their use.
The ruling builds on regulatory action the FDA took last May when it directed manufacturers to revise product labeling for physicians to reflect concerns about adverse cardiovascular and psychiatric events. The concerns came from an FDA review of reports of sudden unexplained death in patients taking usual doses of ADHD products, said Dr. Tom Laughren, director of the division of psychiatry products at the FDA Center for Drug Evaluation and Research, during a teleconference.
Concern about adverse psychiatric events, principally psychotic symptoms, comes from another FDA review, including spontaneous reports and pooled analyses of placebo-controlled trials.
“The causal link is stronger for this event than it is for cardiovascular events,” Dr. Laughren said, noting that adverse psychiatric events occur in about 1 of every 1,000 patients treated.
The ruling applies to 15 products: Adderall tablets, Adderall XR extended-release capsules, Concerta extended-release tablets, Daytrana transdermal system, Desoxyn tablets, Dexedrine Spansule capsules and tablets, Focalin tablets, Focalin XR extended-release capsules, Metadate CD extended-release capsules, Methylin oral solution, Methylin chewable tablets, Ritalin tablets, Ritalin SR sustained-release tablets, Ritalin LA extended-release capsules, and Strattera capsules.
Draft medication guides for these products can be found at www.fda.gov/cder/drug/infopage/ADHD/default.htm