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.42