Endocrine Insider
November 21, 2007

The U.S. Food and Drug Administration (FDA) and GlaxoSmithKline (GSK) have agreed that the black box warning on Avandia (rosiglitazone) should be revised to include results from a meta-analysis of 42 clinical studies. The revised warning will indicate that the meta-analysis revealed an increased risk of myocardial ischemic events in patients taking Avandia when compared to placebo. The label will also reveal, however, that three other studies neither confirmed nor excluded that Avandia increased such risks when compared with other drugs, therefore rendering all available evidence on the cardiovascular risks of Avandia inconclusive.

The Endocrine Society promptly responded to the initial release of the meta-analysis through a statement to healthcare providers. The statement urged the continuation of ongoing studies on the safety of rosiglitazone and encouraged providers to council each of their Avandia patients to determine the risks and benefits of changing therapies. Furthermore, the Society stressed the need for strict and transparent post-marketing surveillance of all new drugs. To read the entire statement, go to http://www.endo-society.org/publicpolicy/policy/avandia.cfm.

As it stands, FDA has concluded that evidence is lacking in regard to whether the cardiovascular risks of Avandia are different from those of other type 2 diabetes oral treatments. GSK has agreed to conduct a long-term study comparing the cardiovascular risks of Avandia with other diabetes drugs. The FDA news release can be viewed at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01743.html.