CHICAGO - A new study led by a federal drug safety expert ties the controversial diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults, and says it is more dangerous than a rival drug, Actos.
The study, a huge review of Medicare records, comes two weeks ahead of a Food and Drug Administration hearing on Avandia's safety. The lead author, Dr. David Graham, is an FDA scientist who wants the pill banned.
As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, Graham told The Associated Press. Harms from Avandia are great enough to "put you in a hospital or in a cemetery," he said.
Editors at the Journal of the American Medical Association rushed to release the study online yesterday, so the information would be available before the July 13-14 hearing, a spokeswoman said.
Avandia is a once-blockbuster drug for Type 2 diabetes, the most common form of the disease and the kind often tied to obesity. Avandia and Actos are pills that help the body make better use of insulin, a key digestive hormone.
The American Heart Association issued a statement reminding patients not to stop taking any medicine without talking with their doctors first. The new study is not definitive enough to prove harm but "deserves serious consideration," the statement says. - AP