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Avandia Removed from Veteran Affairs Drug Formulary

Oct 18, 2007 | Parker Waichman LLP Avandia will no longer be a drug of choice for The Department of Veterans Affairs (VA).  The decision to remove rosiglitazone, known by the brand name Avandia, from the VA drug formulary comes after months of debate over the diabetes medication’s safety.   The VA’s decision is a blow to GlaxoSmithKline, the maker of the drug, because the department makes up about 8% of Avandia’s sales.

In a statement announcing the move, the VA said yesterday that “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.”  The VA said that it would still make Avandia available for patients who were taking it now and wanted to continue. However, the VA has urged doctors to discuss Avandia’s safety issues with these patients.   But the decision means that patients not currently prescribed Avandia will not be able to get it through the VA in the future.

The decision by the VA is not a good one for GlaxoSmithKline, which has already seen sales of Avandia drop by 60% since concerns over its safety were first raised.  While removing the drug from the VA formulary will have an impact on Avandia sales, the effect could be far worse if many VA patients currently taking Avandia decide to switch to something else.   Between September 2006 and August 2007, the VA had issued more than 160,000 Avandia prescriptions.  

Avandia has been a subject of debate since May 21, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack.  Following the publication of that study, it was revealed that in 2005, GlaxoSmithKline, Avandia’s manufacturer, had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. As a result, the cardiac problems were not made public until the Cleveland Clinic published its analysis in May.

In July, the FDA convened a panel to discuss the issues surrounding Avandia’s heart attack risk.  The panel voted 20-3 that the drug did in fact raise the chance of heart attacks, yet the panel still voted 22-1 to allow it to remain on the market.  As a result of that meeting, new warnings were added to Avandia’s label.  The advisory panel recommendations are not binding, and the FDA could still take more drastic action.   The FDA safety review is ongoing, and there are many at the agency pushing to have Avandia removed from the market.

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