Influential U.S. Senator Charles Grassley ripped into the FDA yesterday, saying the agency's own data analysis demonstrated that the diabetes drug Avandia raised the risk of cardiovascular incidents and that up to 100,000 heart attacks could be linked to the drug since it was approved eight years ago. But agency officials held off putting a "black box" warning on the drug, which earned $2.2 billion last year, as it waited for new data from an ongoing study that won't be available for two more years.
"That's a long time from now when you have millions of Americans taking this drug," said a statement from Grassley. "Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem."
- here's the AP report on Avandia
Déjà vu: In an editorial, The New York Times says the FDA and Glaxo will both have a lot of explaining to do if the experts confirm that Avandia presents unacceptable risks. Editorial
Glaxo shares tumble (again) on Avandia risks. Report