GSK Diabetes Drug Avandia May be Unsafe, Near Recall

Two more studies weighing the risks of the GlaxoSmithKline drug Avandia were released on Monday, June 28. These studies showed a link between use of the diabetes drug Avandia and heart attacks in patients. The studies may be a factor to be considered in decisions about whether to place Avandia under FDA recall.

The first study, reports The Washington Post, was published in the Journal of the American Medical Association. The researchers were led by David Graham of the Food and Drug Administration and analyzed Medicare records of more than 227,000 people who took either Avandia or another diabetes drug, Actos. They found that those patients using Avandia had an increased risk of stroke, heart failure and death.

According to Salient News, the second study updated an original work from 2007. The findings were based on analysis of 56 clinical trials showing that Avandia increases the chance of a heart attack by 28 to 39 percent. Cleveland Clinic’s head of cardiology, Dr. Steven Nissen, is the lead author of the studies and a critic of Avandia. “A drug that increases the risk of heart attack by a third or more in diabetics represents a huge public health burden,” said Dr. Nissen.

The Post further reports that according to internal reports released by the Senate Finance Committee earlier this year, FDA officials speculate that if patients on Avandia were switched to another diabetes drug, Actos, 500 heart attacks and 300 cases of heart failure could be prevented every month.

As also noted in a prior post on FindLaw's Injured Blog, the FDA documents were discovered in a two-year investigation into Avandia by the committee. Its report charged that the manufacturer, GlaxoSmithKline, knew of the heart risks associated with Avandia for years before the danger was made known to the public.

Salient News says GSK defends the medication, saying that six randomized clinical trials, considered the gold standard for medical studies, showed that Avandia did not increase the overall risk of heart attack, stroke or death.

An advisory panel meeting is scheduled to be held in two weeks to make a decision about Avandia. In the event that Avandia is pulled off the market, diabetics have as many as 12 different options for medications approved to lower blood sugar.

Related Resources:

• Avandia studies place medication on edge of recall (Salient News)
• Consumer Reports Insights: Doubts surface about the safety of a diabetes drug (Washington Post)
• California County Sues GSK over Diabetes Drug Avandia (FindLaw's Injured Blog)
• Why Drugs Get Pulled from the Market (FindLaw)
• GSK Settles More Avandia Lawsuits (FindLaw's Decided Blog)
• Personal Injuries from Dangerous or Defective Products (provided by Koles, Burke & Bustillo, L.L.P)