New Rosiglitazone Label Includes Restrictions on Use


February 08, 2011

February 8, 2011 (London, United Kingdom) — The US label for rosiglitazone (Avandia, GlaxoSmithKline) and all rosiglitazone-containing medications (Avandamet and Avandaryl) now includes the additional safety information and restrictions requested by the Food and Drug Administration and reflects the cardiovascular concerns about the drug used in the treatment of patients with type 2 diabetes [1].

The new label is the result of the FDA decision that allowed rosiglitazone to remain on the market, but only under a very rigorous restricted-access program. Under the new label, rosiglitazone-containing medications are restricted to patients already taking rosiglitazone or to those unable to achieve adequate glycemic control with other diabetes medications and who have decided, along with their physician, not to take pioglitazone (Actos, Takeda Pharmaceuticals).

The new label has been changed to highlight the increased cardiovascular risks with the drug, noting in a boxed warning that in a meta-analysis of 52 studies, most of which compared rosiglitazone with placebo, the drug was associated with a significantly increased risk of MI. The new label highlights the lack of comparative clinical trials between rosiglitazone and pioglitazone but notes that pioglitazone, in a study compared with placebo, was not associated with an increased risk of death or MI.

The boxed warning also includes previous caveats that rosiglitazone is not recommended in patients with symptomatic heart failure and that it can exacerbate congestive heart failure in some patients.

GlaxoSmithKline is currently working with the FDA to finalize the risk evaluation and mitigation strategy (REMS) program that will restrict the availability of the rosiglitazone-containing medications, a program that was required as a result of the FDA decision to allow the drug to remain available in the US. The company is also working on reanalyzing data from the RECORD trial, with an independent adjudication of cardiovascular outcomes.

The European Medicines Agency (EMA) suspended the marketing authorizations for all rosiglitazone-containing antidiabetes medications licensed in the European Union (Avandia, Avandamet, and Avaglim).