Reports of Avandia-Related Heart Attacks Jumps
The side effects noted by patients taking diabetes drug Avandia tripled in the months after a study linked the drug to increased rates of heart attacks. A report from the U.S. Food and Drug Administration says: "In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped... Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."
Reports of Avandia-Related Heart Attacks Jump, Highlight Flawed FDA Monitoring
The reports may indicate that doctors who were previously unfamiliar with the side effects of Avandia began to report side effects that they had believed to be unrelated to Avandia. However, it is not possible to determine much more than that from the report, though the report is suggestive of the fact that the FDA needs to change its post-approval drug monitoring process.
Related Links:
Legal View: Avandia
FDA Internal Memo: Early "Black Box" Recommendation Ignored
Side Effect Reports Triple After Study Ties Diabetes Drug Avandia to Heart Risks
Don't Panic on Avandia