Risks from Avandia are great enough to "put you in a hospital or in a cemetery.” That’s a direct quote from Dr. David Graham, the lead author of a study, that ultimately led the Food and Drug Administration to hold a hearing on the safety of the popular diabetes drug.
On June 28, the study was released connecting the controversial drug to a higher risk of heart problems, strokes and deaths in older adults, and said it was more dangerous than a rival drug, Actos.
Graham said the study, which was a huge review of Medicare records, warrants enough information for the pill to be banned and pointed out that 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999.
"The evidence is overwhelming," Graham said. "There is not a single study where those two drugs are compared where Avandia doesn't look worse than Actos. How many studies do you have to do before you come to your senses?"
Avandia's maker, the British company GlaxoSmithKline PLC, maintains that its drug is safe. A spokeswoman said the new study has limitations, and that the company looks forward to a full discussion of evidence at the FDA hearing.
This is not the first time Avandia has been under suspicion. In May 2007, when a review of dozens of studies suggested it may raise the risk of heart-related deaths, warnings were added to its label.
Since then, the FDA and Congress have held meetings on the drug, but it has remained on the market, and is still used by hundreds of thousands of Americans.
In response to the trials, 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" and should be discussed between patients and their doctors.
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 both pills that help the body make better use of insulin, a key digestive hormone.
The study by the FDA that put GlaxoSmithKilne under fire involved 227,571 Medicare patients, average age 74, who started on Actos or Avandia from July 2006 through June 2009 and were followed for three years on average.
Avandia patients were 27 percent more likely to suffer strokes, 25 percent more likely to develop heart failure and 14 percent more likely to die than those on Actos, researchers found.
There were 2,593 heart attacks, heart failure cases, strokes and deaths among the 67,593 Avandia users, and 5,386 of those problems among the 159,978 people taking Actos. Just dividing these numbers to compare side effect rates can't be done, though, because people were on the drugs for differing lengths of time.
The findings suggest that if 60 people were treated with Avandia for one year, one extra case of heart failure, stroke or death would occur that could have been avoided if they'd taken Actos instead, Graham said.
At its hearing Tuesday, the FDA plans to examine the latest safety data and air internal disagreement among its scientists over what should be done.
Options regulators can consider include adding more warning labels, limit which doctors can prescribe Avandia or pull it from the market completely.
The Associated Press contributed to this article.