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Glaxo: Avandia's safe as other diabetes drugs

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New England Journal of Medicine
Food and Drug Administration (FDA)
GlaxoSmithKline

Since a New England Journal of Medicine article came out strongly questioning the cardiac safety of its diabetes drug Avandia, GlaxoSmithKline has taken a beating, with its stock declining a substantial 11 percent over eight days. Now Glaxo has come back swinging, arguing that the furor is overblown. Glaxo's chief medical officer, Ronald Krall, has just published a letter in The Lancet arguing that Avandia is as safe as other diabetes drugs. In the letter, Krall notes that the actual number of heart attacks among Avandia patients is less than 1 percent, and was the same for both Avandia users and the control group. Krall also says that analyses of two long-term prospective clinical trails show that the incidence of ischemic cardiac events is comparable to two well-established diabetes drugs, metformin and sulfonylureas.

To check out the Glaxo position:
- read this letter from Krall (.pdf)

Related Articles:
Avandia controversy sparks FDA criticism. Report
Avandia risks exposed under deal to post data. Report

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