Diabetes Drug Once Again under Scrutiny

A couple of weeks before the FDA meets to discuss the safety of the antidiabetic medication Avandia come (coincidentally) more reasons this agent should be withdrawn from the pharma marketplace. One study concludes that Avandia increased the risk of death, heart failure, stroke or heart attack by almost 20 percent compared with its main competitor, Actos. Another trial noting heart-attack risks associated with Avandia found that one of every 52 patients using the drug had an almost 33 percent increased risk of getting one.

Not to be outdone, the pharma manufacturer of Avandia — Glaxo Smith Kline — is standing by the troubled drug, releasing a statement saying that randomized trials show it is, indeed, safe; the American Diabetes Association agrees, saying there is no increase in overall mortality from the drug — independent of its effect on one’s risk of cardiovascular complications. Physicians have gone on record as being, at the very least, circumspect on the safety data trumpeted by GSK — noting flaws[1] every step of the way. | LINK

  1. Physician-critics have said the overall rate of cardiovascular problems among patients in the trial was suspiciously low. Many Avandia patients took statins — 10 percent more than the non-Avandia users — and those cholesterol-fighters are known to cut heart attack risk. Also, they say, a relatively high level of patients dropped out of the trial entirely, which could have compromised the results. []

29. June 2010 by Michael Douglas, MD, MBA
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