On May 22, 2007, consumer advocacy group Public Citizen said the Food and Drug Administration (FDA) knew about the dangers of diabetes drug Avandia in 2002. The group sent a letter to the FDA about an internal memo from July 2002 written by FDA scientists. The memo included recommendations from scientists about changing Avandia’s label to include a warning about reports of heart failure for patients using the drug.

In 2002, the FDA Division of Drug Risk Evaluation found 25 patients taking Avandia who had cases of heart failure serious enough to require hospitalization. In most cases, the heart failure improved when the patient was taken off Avandia.

The memo also cites data that Avandia “may be associated with [congestive heart failure to an extent not clearly defined in the product labels.” The product labels have still not been changed.

“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said. “As a result, millions of people - to the detriment of their health - are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.”

Public Citizen has called on the FDA to ban Avandia or require a black-box warning on its labels.

On May 21, 2007, a review published in the New England Journal of Medicine revealed patients who take Avandia are at a 43 percent higher risk of heart attackand a 64 percent greater risk of cardiovascular death.

In response, the FDA issued a safety alert about the drug’s potential risks but did not issue a recall because other studies of Avandia did not necessarily confirm the risks.

Sources: Sidney M. Wolfe, “Letter demonstrating that the FDA knew about Avandia dangers, urging action (HRG Publications #1820),” Public Citizen, May 22, 2007; “FDA knew of Avandia’s dangers nearly five years ago, memo shows,” Public Citizen, May 22, 2007 (http://www.citizen.org/pressroom/release.cfm?ID=2442); “Memo Re: Adverse Event - Congestive heart failure requiring hospitalization,” FDA Department of Health and Human Service, July 16, 2002 (http://www.citizen.org/documents/AvandiaMemo.pdf); “Did FDA know of Avandia dangers in 2002?” CBS News, May 22, 2007.