FDA Wants Avandia to Carry Heart Attack Warning - WSJ

The FDA wants GlaxoSmithKline to add a black box warning about heart-attack risk to its diabetes drug Avandia, a move that could further hurt sales of the once-popular drug, the Wall Street Journal reported Wednesday, citing unnamed sources. Avandia already carries a black box warning about heart failure, but a heart-attack warning is even more serious, and is not carried by Avandia's main rival drug, Takeda's Actos. Avandia's global sales of $3.38 billion account for a full 7% of Glaxo's total sales. Prescriptions for the drug took a hit in May when cardiologist Steven Nissen published an article in the New England Journal of Medicine outlining its heart risks (full story). The idea of attaching a heart-attack risk warning arose after FDA tests found the drug appeared to carry a 38% higher risk of ischemic events; Glaxo disputes the analysis. Some FDA officials have pushed for Avandia sales to be ceased in the U.S. due to its potential danger (full story), so the new warning may be something of a compromise. Any Avandia woes, the Journal writes, should benefit Actos, and potentially older drugs like Merck's Januvia. Glaxo shares are down 1.3% YTD and 7.3% over the past year.

Sources: Wall Street Journal
Commentary: New Studies: Actos Lowers Heart Risk; Avandia Increases It • Merck, Amilyn Should Profit From Avandia's and Actos' Problems
Stocks to watch: GSK, TKPHF.PK, MRK

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