|Source: Bloomberg News|
The Department of Veterans Affairs (VA) today announced its decision to severely limit the use of Avandia, the once-popular drug for Type 2 diabetes, delivering a blow to the product’s maker, GlaxoSmithKline, according to The New York Times (NYT).
The NYT predicted that the VA’s decision will likely further reduce sales of Avandia, once a $2.2 billion U.S. franchise. U.S. sales of the drug have declined by an estimated 60 percent since May, when the New England Journal of Medicine published a study suggesting that Avandia can increase the risk of a heart attack by more than 40 percent.
In June, the FDA placed warnings concerning heart failure risks on the labels of Avandia, but in July, a federal advisory panel voted overwhelmingly to keep Avandia on the market. Currently, the FDA is conducting a full-scale review of the safety and efficacy of the drug.
The VA decided to remove Avandia, and its generic version, rosiglitazone, from its formulary on Oct. 5, according to a statement yesterday. The agency, which treated more than five million veterans last year, issued more than 161,000 Avandia prescriptions from September 2006 to August 2007, Terry Jemison, a VA spokesman told The NYT.
“The Department of Veterans Affairs conducted its own review and has concluded that, for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies,” according to the statement published in The NYT.
The VA statement indicated that Avandia would be available for patients already using it, if they chose to continue, but the agency is urging doctors to inform patients about the drug’s risks and benefits. “The VA will not provide it to patients for whom it is not currently prescribed,” the agency noted.
Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, told The NYT it was too soon to gauge the impact of the decision, because it was not clear how many of the VA patients currently using Avandia would choose to keep taking it.