FDA Pulls Diabetes Drug Avandia from Retail Sales

The U.S. Food and Drug Administration (FDA) is putting new restrictions on the sale of the diabetes drug Avandia (rosiglitazone), used to treat Type 2 diabetes in millions of Americans, 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.

"During its use there was chest pain, shortness in breathing, itching, muscular weakness, fatigue and yellow color of skin and bone pain," said Sharma of Foley, Ala., who said the drug amounted to "[waste] of money to buy an early death."  David of Ft. Myers, Fla., said he had a stress test after he stopped taking the drug and "the doctor pointed out had I still been on the drug I would have died! Wonderful eh?"

Beginning in November, the controversial drug 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.  

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."

Cover-up?

In an article published in April 2010, The New York Times said it had obtained documents that show SmithKlineBeecham -- the firm's name in 1999 -- buried a disastrous study that suggested Avandia posed greater heart risks than a competing drug.

As evidence of a smoking gun, the Times points to this 2001 email from Dr. Martin I. Freed, a GSK executive: "This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK," the email states. 

The Times report said the documents it uncovered demonstrated the company was sitting on incriminating data that surfaced soon after Avandia's introduction. In one document cited by the newspaper, GSK tried to add up the lost sales that would result if Avandia's heart safety risk became established. The document put the cost at $600 million over a two-year period.