Testing has definitively indicated that the benefits of diabetes drugs containing rosiglitazone outweigh the risks -- as such, the U.S. Food and Drug Administration (FDA) has lifted mandates requiring the labeling on these medications to include risk warnings.
Drugs affected under the change include Avandia, Avandamet, Avandaryl and several generics.
Rosiglitazone is indicated for use in combination with diet and exercise regimens. The therapy aids in the control of blood sugar in patients living with type 2 diabetes.
In 2013, FDA officials ordered the removal of labeling indicating medications containing rosiglitazone could lead to an increased risk of heart attack; also that year manufacturers of the drugs were mandated to provide educational materials and training regarding rosiglitazone to health care providers.
After more than two years of monitoring, FDA officials determined benefit and risk information was no longer necessary on rosiglitazone labeling.
