Panel Tells FDA to Postpone ADHD Drug Labeling Changes

Members of the Pediatric AdvisoryCommittee recently informed theFDA that it was hesitant to recommenda label change for a class ofstimulants used to treat attentiondeficit/hyperactivity disorder (ADHD),according to a press release posted onthe FDA Web site. The committeereported that it did not come acrossany new concerns about psychiatricside effects with Concerta and othermethylphenidates, such as Ritalin andMetadate. The panel also recommendedthat the FDA wait until more safetydata have been collected on 2 othertypes of drugs for ADHD—methamphetamines, such as Adderall,and the nonstimulant atomoxetineHCl (Strattera).

Reports of psychiatric events andpossible cardiovascular side effectsprompted the FDA to consider labelingchanges to all methylphenidates. Areview found 36 psychiatric events forConcerta, compared with 16 for Ritalinand other methylphenidates. Concertahad 20 cardiovascular events,compared with 4 reports with othermethylphenidates.

Although the committee recommendeddelaying labeling changes,Dianne Murphy, MD, director of theOffice of Pediatric Therapeutics, saidthe FDA may still move forward withthe change regarding psychiatric sideeffects to "try and make it clearer whatthe situation is with regard to certainadverse events."