Reactions 1095 - 1 Apr 2006
The US FDAs Pediatric Advisory Committee hasrecommended that attention-deficit hyperactivitydisorder (ADHD) drug labels do not need a black boxwarning for potential psychiatric and cardiovascular(CV) events, following potential episodes ofaggression, psychosis and cardiac events in children.Instead, the committee has recommended that thepsychiatric risks be described in the Warnings sectionsof ADHD drug labels and that the current language onamphetamine labels about CV risks in patients withstructural cardiac abnormalities should be extended toall ADHD drug labels. The committee alsorecommends that a medication guide describing thesepotential risks be issued, and that the warnings andMedGuide should apply to all ADHD drugs, includingRitalin [methylphenidate], Adderall, Concerta[methylphenidate], Strattera [atomoxetine] and Sparlon[modafinil].US FDA Advisory Committee. ADHD Black Box Warning On Psychiatric/Cardiac Events Is Unnecessary, Pediatric Committee Says. Media Release : 23Mar 2006. Available from: URL: http://www.fdaadvisorycommittee.com 809061666
Editorial comment: Earlier this year, the FDAs DrugSafety & Risk Management Advisory Committeerecommended the addition of black box warnings to ADHDdrugs for CV risks in adults [see Reactions 1089 p3;800999850].
Reactions 1 Apr 2006 No. 10950114-9954/10/1095-0001/$14.95 Adis 2010 Springer International Publishing AG. All rights reserved