FDA confirms safety risk of Avandia

Although we already know why Avandia is still on the market, the FDA released the preliminary results of its evaluation of the GlaxoSmithKline drug. Here are the results via the Washington Post:

The government’s own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration “several months ago” recommended a “black box” on the drug’s label — the strongest possible warning…

Grassley complained that FDA higher-ups have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision. “That’s a long time from now when you have millions of Americans taking this drug,” said the statement by the Iowa Republican. “Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem.”

GSK, meanwhile, disputes the findings:

Company officials said that while their own similar analysis suggested a 31 percent greater risk — information it shared with the FDA as early as 2005 — more rigorous, albeit smaller, individual studies did not show that.

Please — this drug should have had a black-box warning on it the day it was released.

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