Diabetes Meds Avandia and Januvia Under Renewed Scrutiny by FDA

Washington, DCType 2 diabetes medications Avandia, Januvia, and Byetta are making the news right now, for all the wrong reasons. Reports out of London and Washington this week state that in June, the Food and Drug Administration (FDA) will be re-reviewing results of a re-analysis of a 2009 study called Record, which showed a more than doubling of the risk for heart failure associated with Avandia (GlaxoSmithKline[GSK]). Bloomberg reports the re-analysis was requested by a previous advisory panel that found the drug should remain available in the US, despite its having been taken off the market in Europe.

The GSK-funded study was done by the Duke Clinical Research Institute in Durham, North Carolina, and involves 4,500 patients enrolled in the trial from 2001 through 2009, FDA spokesperson Morgan Liscinsky, said, adding that the findings could change the way Avandia is handled.

Merck’s Januvia and Janumet, Bristol-Myers Squibb’s Byetta and Bydureon, and Novo Nordisk’s Victoza are is also coming under renewed scrutiny by the FDA resulting from reports of pancreatitis associated with the type 2 diabetes medications.

In our recent diabetes drug lawsuit update published this week, attorney Ben Steward discusses the status of lawsuits pending against the manufacturers of these diabetes medications.