Class Action Claims Avandia Harmed Diabetes Patients

New restrictions on the sale of Avandia may protect diabetes patients from future complications but they're doing nothing to stem the flow of individual and class action lawsuits against GlaxoSmithKline from consumers who say they've already been harmed by the drug.

The U.S. Food and Drug Administration (FDA) last month imposed strict new measures to limit the use of Avandia (rosiglitazone) after years of consumer complaints, petitions and public appeals that it take action against the drug which many consumers say made their conditions worse rather than better.

Thousands of individual injury suits have already been filed and a new class action was filed recently on behalf of 43 plaintiffs in Illinois' St. Clair County Circuit Court.

The plaintiffs in that suit allege that GlaxoSmithKline knew that Avandia increased the risk of heart problems as early as 2005, but failed to adequately warn patients.

The lawsuit seeks damages in excess of $650,000 and charges GlaxoSmithKline, SmithKline Beecham Corporation and McKesson Corporation with breach of warranty, fraud, misrepresentation and negligence.

No more retail

Beginning in November, Avandia will no longer be sold at retail pharmacies. It will only be available to patients who have been using it without complications, patients who have had no luck with drugs and those who choose to continue taking the drug after being informed of the risks.

"Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program," the FDA said. "The drug manufacturer, GlaxoSmithKline, will withdraw rosiglitazone medicines from the current supply chain and will provide pharmacies with instructions on returning the medicines."

Rosiglitazone is also sold under the names Avandamet and Avandaryl when it is combined with other drugs. The new rules apply to those combination drugs as well.

The consumer group Public Citizen petitioned the FDA in 2008 to ban the drug, saying it is dangerous and can cause death from liver failure and many other life-threatening risks.  

Sharp drop-off

Avandia prescriptions fell sharply following a May 2007 study published in The New England Journal of Medicine connecting the drug with increased heart attack risk. In 2006, the number of people taking the drug peaked at 13.2 million. Since then, that number has dropped to 4.6 million for the last full year. This means that about 10,000 prescriptions a day are still being filled for this dangerous drug.

"The scientific consensus against Avandia is overwhelming," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a statement issued in October 2008. "The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug."