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April 2006 Medications to treat attention-deficit/hyperactivity disorder (ADHD) do not need a black box warning against potential cardiovascular and psychiatric adverse events, but the FDA’s Pediatric Advisory Committee wants to see the risks outlined in the medications’ labeling. Common pharmacotherapy treatments for ADHD include atomoxetine (Strattera, Lilly) and stimulants, such as methylphenidate (Concerta, Johnson and Johnson; Methylin, Alliant; Metadate, UCB/Celltech), amphetamine-dextroamphetamine (Adderall, Shire; Dextrostat, GlaxoSmithKline), methamphetamine (Desoxyn, Ovation) and dexmethylphenidate (Focalin, Novartis). In February, the FDA’s Drug Safety and Risk Management Advisory Committee members were split (8-7) over a decision to recommend a black box warning on ADHD drugs used by adults. Twenty-five people who were taking the drugs died between 1999 and 2003, prompting that meeting. Many of those patients had heart conditions. The pediatric committee felt that the cardiovascular risks of the medications were different for children than for adults. Members suggested labeling that outlines the potential risks for children with structural cardiovascular abnormalities. The committee also suggested pediatricians discontinue use of an ADHD drug if it causes psychiatric events in their patients. The committee members were most concerned with reports of hallucinations. Both committees want to see a MedGuide that describes both cardiovascular and psychiatric risks. The day after the pediatric committee held its discussion, the Psychopharmacologic Drugs Advisory Committee recommended further study of Cephalon’s modafinil (Sparlon) for treatment of ADHD in children and adolescents. Although that committee unanimously agreed that the drug was efficacious, members did not feel the available data demonstrated an acceptable safety profile. Safety concerns surrounded one possible case of Stevens-Johnson syndrome in 933 clinical trial participants. |
