Quoted from http://www.bloomberg.com/news/2013-06-03/glaxo-findings-on-avandia-safety-supported-in-reanalysis.html
Glaxo Findings on Avandia Safety Supported in ReanalysisBy Anna Edney - Jun 3, 2013 10:21 AM ET
A second look at GlaxoSmithKline Plc (GSK)’s once-best-selling diabetes pill found it doesn’t increase overall cardiac death risk, U.S. regulators said.
Findings by London-based Glaxo that Avandia doesn’t raise the overall risk of death, heart attack or stroke appear to be supported in a reanalysis by independent researchers, some Food and Drug Administration staff said in a report today. FDA advisers will reconsider restrictions imposed on Avandia in 2010 at a meeting June 5-6, according to the report.
“It is important to note that FDA has not reached any final updated conclusions” on the cardiovascular safety of Avandia based on the reassessment, said Mary H. Parks, director of the FDA’s division of metabolism and endocrinology products.