GlaxoSmithKline has finalized an update for the warning label and medication guide of their diabetes drug Avandia, which includes information on new FDA required restrictions on use and concerns about potential heart problems with Avandia.
In a press release issued Monday, the company said that the changes will affect all rosiglitazone-based drugs; including Avandia, Avandamet and Avandaryl.
The labels and guides will note that Avandia is only available to patients who are already taking the drug or who have failed to control their diabetes with other medications. It also includes an updated black box warning that notes that clinical trials show a “statistically significant” increased risk of myocardial infarction and notes that trials have indicated that Takeda Pharmaceuticals’ Actos, a competing drug, does not appear to carry the same risks.
Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales plummeted following the concerns about potential Avandia heart risks.
In September 2010, the FDA determined that the black box warning added in 2007 was not enough and issued stronger warnings about Avandia and restricted use. The agency determined that only patients who have failed to control their diabetes through every other available medication should be given access to the medication, and ordered the drug’s maker, GlaxoSmithKline, to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted. The decision came after an FDA advisory committee narrowly voted this summer not to issue an Avandia recall.
GlaxoSmithKline said in its press release that it continues to work with the FDA on developing a REMS program.
The drug maker faces thousands of Avandia suits filed by people who allege that they suffered an injury as a result of the drug maker’s failure to adequately warn about the risk of heart problems.
A number of Avandia settlements have reportedly been reached by GlaxoSmithKline in an effort to resolve the Avandia litigation.