Healthy Skepticism Library item: 12262

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Publication type: news

Rubin R.
Year in Health: Here's to your safety
USA Today 2007 Dec 23
http://www.usatoday.com/news/health/2007-12-23-yearend-diabetes_N.htm?POE=click-refer

Full text:

Persistent questions about the safety of both prescription and over-the-counter drugs, a menacing microbe spreading throughout the U.S. and a globe-trotting TB patient garnered headlines this past year. A look back at the top health stories of 2007:
Avandia gets ‘black box’ treatment

Yet another blockbuster drug lost some of its luster in 2007. But unlike Vioxx, the arthritis drug pulled off the market in 2004 because of safety concerns, Avandia is still around.

Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, got everyone’s attention in May when he reported that diabetics who took Avandia were 43% more likely to have a heart attack or be hospitalized for blocked coronary arteries than other patients in clinical trials.

In July, a Food and Drug Administration advisory panel voted 20-3 that Avandia, used to treat type 2 diabetes, increases heart risks. But they voted 22-1 that its risk/benefit profile merits it staying on drugstore shelves. Maker GlaxoSmithKline says Avandia sales have fallen since Nissen’s findings appeared in The New England Journal of Medicine.

It’s long been known that Avandia and Actos, the other drug in its class, raise the risk of congestive heart failure. In August, the FDA announced a stronger warning, a “black box,” on both drugs’ labels against their use in patients with advanced congestive heart failure.

Based on Nissen’s study and others, the FDA added information to Avandia’s black box last month about a potential increased heart attack risk. The FDA has asked Glaxo to compare Avandia’s heart attack risk with that of other diabetes pills, but you won’t be reading about those findings until 2014.