VA Restricts Availability of GSK’s Avandia

The Department of Veterans Affairs (VA) has removed GlaxoSmithKline’s (GSK) Type 2 diabetes drug Avandia from its national formulary and is restricting the drug’s availability.

GSK recently agreed to add a boxed warning about the risk of heart failure to Avandia’s (rosiglitazone maleate) label. After reviewing postmarketing adverse event reports and finding warning signs of heart failure, the FDA determined all Type 2 diabetes drugs in the thiazolidinedione class, such as Avandia, required the warnings.

The VA also conducted a safety review and determined Avandia “may not afford the same margin of safety as alternative drug therapies.” The VA will not provide Avandia to patients who do not have a prescription for it. However, the VA will allow patients already using the drug to continue using it.

The decision could serve as another blow to GSK as Avandia sales have slipped. From September 2006 to August, the VA issued more than 1.38 million Avandia prescriptions. A GSK spokesman could not say what percentage of domestic prescriptions that figure represents.

Avandia sales fell 22 percent in the second quarter to $715 million after a meta-analysis appeared in the New England Journal of Medicine showing that the drug increased the risk of death from cardiovascular causes by 64 percent.