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Possible Black box warnings and medication guides for ADHD Drugs

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The FDA Advisory Committee published an alert today regarding possible black box warnings and medication guides for ADHD Drugs.

Attention deficit/hyperactivity drugs should be prescribed with a medication guide warning of potential cardiovascular risks with the class of stimulant agents, FDA’s Drug Safety & Risk Management Advisory Committee recommended Feb. 9.

FDA conducted an analysis of adverse event rates for the ADHD drugs amphetamine/dextroamphetamine (Shire’s Adderall, Adderall XR, and Dextrostat; GlaxoSmithKline’s Dexedrine and Dexedrine Spansules), methylphenidate (J&J’s Concerta; Novartis’ Ritalin, Ritalin SR, and Ritalin LA; Alliant’s Methylin and Methylin ER; UCB/Celltech’s Metadate ER and Metadate CD), methamphetamine (Ovation’s Desoxyn) and dexmethylphenidate (Novartis’ Focalin).

The committee’s concerns included higher rates of serious cardiovascular events and sudden death for amphetamine than for methylphenidate in both children and adults, and more events were seen in adults than children.

Read more about these dangerous drugs.