GSK agrees to amend black-box warning on Avandia per FDA

WASHINGTON The Food and Drug Administration announced today that GlaxoSmithKline has agreed to add new information to the existing black-boxed warning on its Type 2 diabetes drug Avandia, warning of the drug’s potential for increased risk of heart attacks.

In August, the agency had added warnings that Avandia, Actos and drugs in combination with such medications as Avandamet and Actoplus Met would receive a new warning about a risk of heart failure.

Now, as then, the agency is stating that the medication will stay on the market, but should be closely monitored by a physician.

The FDA has also concluded that, as of now, there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and other Type 2 diabetes drugs. As a result, the FDA has asked GlaxoSmithKline to conduct a new long-term study, which the company has agreed to take part in, to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent.

The new warning will state the following:

“A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”

The FDA stated that it does plan on conducting these studies with other Type 2 diabetes medications such as Actos, which is manufactured by Takeda.