FDA approves new warnings on Avandia packaging

New warnings for the type 2 diabetes drug rosiglitazone, better known by the brand name Avandia, has been approved by the Food and Drug Administration (FDA). The warnings, including a black box warning, will be immediately added to the safety labeling and packaging for Avandia (rosiglitazone maleate), as well as other drugs with the same active ingredient, including Avandament (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepride).

A black box warning, or boxed warning, is the strongest warning the FDA can issue and is given to prescription drugs that may cause serious or life threatening health consequences. The boxed warning section describes the risk for congestive heart failure and myocardial infraction, or heart attack, as statistically significant based on clinical trials.

Also added to the warnings and precautions section of the safety information for rosiglitazone are warnings for cardiac failure, adverse cardiovascular events, and fractures. The adverse reactions section was also updated to include a possible increased risk for heart attack when Avandia is used in combination with insulin.

Last fall, the FDA voted to put tight restrictions on Avandia and other drugs in its class based on data from clinical trials that showed use of the drug put patients at risk for cardiovascular events such as heart attacks and strokes. The FDA also ordered makers of the drug to update the product’s safety label to include the warnings. Since the FDA’s ruling, in order for Americans to continue to receive the drug, their doctors must attest to and document their patients’ eligibility. Patients will also have to review statements describing the cardiovascular safety concerns associated with Avandia and acknowledge they understand the risks.