The FDA disclosed Wednesday during a Congressional hearing it has asked GlaxoSmithKline and Takeda Pharmaceutical to add a "black box" label warning about heart failure to their diabetes drugs, Avandia and Actos. The request was made on May 23, two days after a New England Journal of Medicine article authored by cardiologist Steven Nissen tied the drug to a potential risk of heart attacks. Both companies said they were discussing the warnings with the FDA. House Rep. Henry Waxman (Dem-CA) said the FDA "dropped the ball" in its oversight of Avandia: "FDA needs the will, the resources and the authority to be a more effective watchdog of drug safety." Dr. John Buse, incoming president of the American Diabetes Association, said that when he voiced his fears that Avandia might increase heart risk in 1999, he was threatened in phone calls from Glaxo. Other House Representatives were less convinced. Darrell Issa (Rep-CA) said the House committee was close to "politicizing science" and questioned Dr. Nissen. On Tuesday, Glaxo published an interim study that suggests its drug does not increase the risk of heart attack or death. The labels of both drugs already warn about heart failure, but not with black boxes. In a May 21 note, Bear Stearns said Avandia's headline risk could benefit Merck's Januvia and Eli Lilly's/Amylin Pharmaceuticals' Byetta. Novartis' Galvus and Bristol-Myers'/AstraZeneca's saxagliptin, which also compete, are due out in late-2008 or 2009. Glaxo shares dropped 0.8% Wednesday to $51.46; they are down 11% since May 19.
Sources: Glaxo statement, Wall Street Journal, New York Times, Seeking Alpha
Commentary: Glaxosmithkline: The Cheapest Large Cap Pharma Stock? • GlaxoSmithKline Defends Avandia Against Charges of Cardiovascular Risks • GlaxoSmithKline's Avandia: Trouble or Not?
Stocks/ETFs to watch: GlaxoSmithKline plc (GSK), Eli Lilly and Company (LLY) [co-manufacturer of Actos], Merck & Co. Inc. (MRK), Amylin Pharmaceuticals Inc. (AMLN), Bristol-Myers Squibb Co. (BMY), Novartis AG (NVS), AstraZeneca plc (AZN)
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