Avandia Update: GlaxoSmithKline Faces Investigation for Withholding Data
Deputy FDA Commissioner Josh Sharfstein reported that the agency is investigating whether or not Glaxo broke the law by withholding data indicating Avandia may carry an increase risk of heart attacks. The Wall Street Journal reports that the FDA is currently reviewing documents that Glaxo released to the Senate Finance Committee as part of the committee’s two year investigation of the drug.
Time magazine reports that FDA reviewer Robert Misbin became concerned about Avandia in 2006 after he saw data suggesting a 31% increase in heart attack risk associated with use of the drug. Senator Charles Grassley, a ranking member of the Senate Finance Committee has already stated that the makers of Avandia shouldn’t have waited so long to alert doctors and patients about Avandia’s potential risks.
The Deputy Commissioner’s statements are the most recent bad news for GlaxoSmithKline. The pharmaceutical company already faces multiple lawsuits and has faced increasing federal scrutiny of Avandia for over three years. The New York Times also referenced potentially uncounted adverse events associated with Avandia in a recent article regarding the potential bribery or FDA and other government officials.
If you or someone you know suspects they have suffered a heart attack or other injury due to Avandia, you should consider discussing the issue with a products liability attorney. The attorneys of Bahe Cook Cantley & Jones are actively litigating Avandia cases. To consult with Shawn Cantley about these issues: Shawn's Mail
