It's time to add insult to injury in Avandia-land. It wasn't enough that a new study in the Journal of the American Medical Association find that the diabetes drug doubles the risk of heart failure and boosted heart-attack risk by 42 percent. Another JAMA study showed that Actos, a rival drug, actually lowered the risk of heart attacks, strokes and death (though risk of heart failure did rise).
GlaxoSmithKline defended Avandia, saying that the new studies are "flawed" and that they offer "no new information." The company says the drug is still safe and effective when used appropriately. Still, inspired by all the bad publicity, patients have switched drugs and docs have put the brakes on new prescriptions--meaning, of course, that sales have plunged.
Could further regulatory action be far behind? An FDA advisory panel voted in July to leave Avandia on the market; since then, the drug was slapped with a "black box" warning. Now, a JAMA editorial claims that, had the FDA known now what it did when Avandia came up for approval, the drug would never have hit the market. The authors of these new studies say it should be withdrawn. No question: The pressure on the FDA to act again has intensified. All the agency will say now is that it's continuing to monitor the situation.
- see Glaxo's defense of Avandia
- here's the article from The New York Times
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