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Avandia News Grassley Questions FDA on Avandia Vote- FDA News 10/31/2007- Senate Finance Committee Ranking Member Chuck Grassley (R-Iowa) is questioning the FDA about an alleged vote by its Drug Safety Oversight Board (DSOB) to keep GlaxoSmithKline’s (GSK) Type 2 diabetes drug Avandia on the market. Committee investigators learned the FDA convened its DSOB Oct. 2 and the board voted 8–7 to keep Avandia (rosiglitazone maleate) on the market, Grassley wrote in a letter to FDA Commissioner Andrew von Eschenbach. However, he said, the FDA has not notified the public of the vote. Grassley is requesting information on the FDA’s internal policies and procedures regulating the DSOB and stipulating when information from the board can be released to the public. The Department of Veterans Affairs, whichrecently removed Avandia from its national formulary and restricted its availability over concerns with the drug’s safety, cast one of the votes to remove the drug from the market, Grassley said. GSK recently agreed to add a black box warning about the risk of heart failure to Avandia’s labeling. Grassley said, citing The Wall Street Journal, that the FDA is discussing adding a black box warning for heart attacks to the labeling. Grassley’s letter can be seen at grassley.senate.gov/public/index.cfm?FuseAction=PressReleases.Detail&
If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia lawyers of Ennis & Ennis, P.A. today about an Avandia lawsuit. Call us toll free for a free, confidential case evaluation or fill out our online Avandia case evaluation form. |
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