13 July, 2010
Some questions faced by a panel of experts at a joint FDA drug advisory committee meeting taking place today and tomorrow…
If Avandia use causes increased cardiovascular risks compared to rival diabetes drug Actos, should the FDA recall Avandia? Would adding a new warning label and package insert be sufficient? What should doctors and diabetes patients think about Avandia in light of the controversy surrounding its safety? Continue reading FDA opens hearings to evaluate Avandia safety, vote on recall
Category: Uncategorized11 July, 2010
Advisory Committee Briefing Document: Cardiovascular Safety of Rosiglitazone
Prepared by GlaxoSmithKline for the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
Meeting on July 13-14, 2010 Continue reading FDA Advisory Committee Briefing Document: Cardiovascular Safety of Avandia
11 July, 2010
Avandia FDA Advisory Committee Briefing Document Abbreviations
AE Adverse event ACR Albumin creatinine ratio ACS Acute Coronary Syndrome BARI 2D Bypass Angioplasty Revascularization Investigation 2 DiabetesCategory: Avandia FDA | Avandia News
8 July, 2010
The FDA’s staff report on Avandia safety and all supporting data will be made public tomorrow. An Avandia recall may not be far behind
A report on Avandia safety risks is expected to be released tomorrow by the Food and Drug Administration. The future of the diabetes drug hangs in the balance. Critics claim Avandia heart risks outweigh its benefits and long have demanded an Avandia recall. Several scientific studies, including two released last week, have linked the drug to higher heart risks than other diabetes drugs. Continue reading Avandia safety risks FDA staff report, data to be released July 9, 2010
Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety1 July, 2010
Three new studies about Avandia side effects and heart risks were released this week. Two link the diabetes drug to an increased risk of heart attack, stroke or heart failure. The third suggests that taking Avandia may be associated with a lower risk of heart attack, stroke or death than not taking Avandia or Actos, its rival TZD. As the July FDA drug safety meeting approaches and Avandia lawsuit settlements are reported, demands for an Avandia recall are intensifying. Continue reading Cardiac researcher predicts new heart risks warning, but no Avandia recall by FDA
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Recall | Avandia Safety