WITH AVANDIA, FDA JEOPARDIZES DIABETICS' HEALTH

September 28, 2010

Important FDA Decision on Avandia
Last week, the Food and Drug Administration (FDA) announced it will not ban the dangerous diabetes drug Avandia (generic name: rosiglitazone). Once again, the agency failed to protect public health and instead caved in to industry pressure.

Although the FDA made progress by severely restricting access to the drug, it did not go far enough. Too many people still will be exposed to this dangerous product, which is linked to increased risks of cardiovascular events such as heart attack and stroke.

The FDA should have acted with its European equivalent, the European Medicines Agency, which banned Avandia from the European market the same day the FDA announced it would merely restrict access to the drug.

FDA Fails to Protect Millions
It is outrageous that the FDA did not ban Avandia and took years to decide that this drug - with no evidence of any health advantages and abundant evidence of a variety of risks compared to other diabetes drugs - should be severely restricted.

In March 2000, Public Citizen petitioned the FDA to alert health professionals and the public of serious heart function and other safety issues with the glitazone drug class, which includes Avandia, Actos and Rezulin (Rezulin was removed from the market in 2000). At an FDA advisory committee meeting more than three years ago, we urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the U.S. This means that in the past three years alone, tens of thousands of patients have died or been hospitalized for heart failure as a result of taking this unsafe drug.

Not a single study finds Avandia safer or more effective than Actos, but numerous studies find Avandia to be more dangerous. The FDA and GlaxoSmithKline, the pharmaceutical giant that makes Avandia, acted recklessly in allowing Avandia to stay on the market for so long after its dangers have been known.

As a WorstPills.org subscriber, you knew about the unique risks of Avandia, because we warned consumers about this drug for years.

What You Should Do
If you are using Avandia, discuss the dangers of the drug with your health care provider. Please be aware that we list Actos, like Avandia, as a Do Not Use drug on WorstPills.org because the drug is linked to liver damage, weight gain, anemia and heart failure. On September 17, the FDA issued a warning concerning a possible risk of bladder cancer in patients taking Actos. But do not stop using Avandia or Actos without discussing this with your health care provider first.