Updated: The diabetes drug Avandia has been the subject of several lawsuits, claiming that the drug can cause heart attacks and strokes. Manufacturer GlaxoSmithKline Plc. Is the biggest drug maker in the U.K. has agreed to settle nearly 10,000 lawsuits, paying an average of $46,000 to each plaintiff. With more than 13,000 lawsuits facing the company Glaxo is making these settlements before facing its first federal Avandia trial in October.
While these claims are being settled the United States is waiting for the decision of an FDA advisory panel concerning the drug Avandia as well. The meeting is to determine whether the ability of the drug to control blood sugar levels outweighs the possibility of heart attacks, stroke and death from heart complications.
In 2007 after being on the market for more than 5 years an FDA panel was called to review the risks of the drug and if it should remain on the market. At that time warnings were issued for the drug. Over the past 3 years more than a dozen clinical trials and studies have been performed causing the FDA to take another look at the dangers of Avandia.
The panel which is meeting this week could recommend removing Avandia from the market entirely, limiting the ability to prescribe the drug or simply issuing stronger warnings. These panel committee meetings are often what the FDA uses to make their ruling on drugs. The FDA does not have to abide by the decision of the committee, but they usually do.
When considering the future of Avandia it doesn’t look good even if the FDA agrees to keep it on the market. At the time of the first advisory committee meeting in 2007 Avandia was GSK’s 2nd best selling
drug, afterwards it dropped to 8th. Now that lawsuits are being settled and coming to trial along with the new advisory panel the popularity of Avandia as a diabetic medication of choice is likely to drop even more. There are other diabetes medicines on the market that are undergoing studies to see if they are adequate to step in and take Avandia’s place.
The future of diabetes medications is up in the air, leaving physicians, patients and the FDA at a loss as to what to do. These advisory panels take into account all studies submitted and hear presentations by company representatives, advocates and naysayers as well. The results of the current committee meeting will affect the future of the drug Avandia as well as the future of all diabetes drugs.