August 2007 Issues

FDA Highlights Value of Genetics in Dosing of Warfarin and Codeine

Summary: In two separate advisories in one week, the FDA, as part of its Critical Path Initiative, flagged genetics as a potential factor when it comes to prescribing the correct dose of two drugs − warfarin (Coumadin) and codeine. Both will get new labels describing the genetic factors involved and tests available to determine whether a patient may need a lower dose.

FDA Approves Risperdal for Children and Adolescents

Summary: On August 22, 2007 , the FDA approved the first atypical antipsychotic – Johnson & Johnson’s Risperdal (risperidone) – for use in children and adolescents with two psychiatric disorders.

FDA Advisory Panel Says Avandia Risky but Should Stay on Market -- Quick Pulse

Summary: On July 30, 2007 , two FDA advisory committees, meeting jointly, voted overwhelmingly to keep GlaxoSmithKline’s controversial diabetes drug Avandia (rosiglitazone) on the market, despite determining that it increases the risk of a heart attack. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 20 to 3 that Avandia increases cardiac ischemic risk in Type 2 diabetics, but they voted 22 to 1 that, instead of pulling the drug, the FDA should require strong, new warnings, or black boxes, in the label.

FDA Advisory Panel Recommeds Restricted Approval of Tysabri for Crohn's Disease -- Quick Pulse

Summary: The FDA’s Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended approval of Biogen Idec/Elan Pharmaceuticals’ Tysabri (natalizumab), a multiple sclerosis drug, for moderate-to-severe Crohn’s disease (CD), an inflammatory bowel disorder. The panel voted 12-3, with two abstentions. Two committee members left before the final vote. The panel said that Tysabri’s use should be limited to patients for whom other therapies have failed, and it also said that Biogen Idec and Elan must implement strict post-marketing surveillance to monitor for possible deadly side effects.