A Food and Drug Administration (FDA) committee decided last week to leave the diabetes drug Avandia on the market, but recommended changes to existing warnings and restrictions on how the drug is prescribed. This decision came just a few days after the drug’s maker, GlaxoSmithKline, agreed to pay $460 million to resolve more than 13,000 existing products liability lawsuits related to Avandia.
The FDA committee met to discuss potentially pulling the drug off the market in the wake of several studies that have linked it to increased risk of heart failure and other health problems for those patients taking the drug to treat their type 2 diabetes.
Of the 33 committee members, 12 voted to take the drug off the market, three supported leaving it on the market with existing warnings, seven recommended the inclusion of additional warnings, 10 suggested both the inclusion of additional warnings and greater restrictions on prescriptions, and one committee member abstained from voting.
It is not clear at this time what exactly the FDA will do in the way of adding new warnings or attempting to restrict the sale of the drug. At this time, the drug remains on the market and is still available to those that have prescriptions.
GlaxoSmithKline insists that several studies have shown Avandia is safe for its intended use despite the numerous studies linking the drug to heart failure and other health problems. However, others have claimed that some of the studies GlaxoSmithKline relies on appear to be biased or sloppy and fail to fully report health problems and deaths associated with the drug.
Sales of Avandia amounted to about $1 billion dollars last year, but that total was down from almost $3 billion in 2006. Avandia had been the best selling diabetes pill in the world until studies appeared in 2007 linking the drug to heart problems.
Split Decision from FDA panel on Avandia (CNN.com)