GSK revises Avandia labeling

The existing boxed warning has been revised to add the FDA’s conclusion that, while an FDA meta-analysis of short-term studies, mostly against placebo, showed an association between Avandia and an increase in myocardial ischemic events, that risk was not confirmed or excluded in three long-term clinical trials comparing Avandia against both placebo and other oral anti-diabetes medicines. The box will state that the available data on the risk of myocardial ischemia are inconclusive.

The FDA has also concluded there is insufficient information available to determine whether any oral anti-diabetic medicine reduces cardiovascular risk. The FDA has directed that the sentence, “there have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral antidiabetic drugs” will be added as a warning on the labels of all oral anti-diabetic medicines.

The Avandia label has also been updated to add that the medicine is not recommended, though not contraindicated, for use with patients who are taking insulin or nitrates. The label summarizes the data on myocardial ischemia to help doctors continue to evaluate which patients could benefit from taking Avandia, and those for whom alternative treatment should be considered.