JAMA: Actos, Avandia risky for 65-plus

And the studies keep coming [1]. An independent study of 159,000 older people with diabetes found that patients treated with GlaxoSmithKline's Avandia and Takeda Pharmaceuticals' Actos had a higher risk of heart attack and death. Published in the Journal of the American Medical Association, the study concluded that these patients had a 60 percent increase in the risk of heart failure, 40 percent increase in heart attack risk, and a 30 percent increase in the risk of death.

"At least in this high-risk population, the harms may outweigh the benefits," the study's lead author said. For every 100 people treated with Actos or Avandia over a four-year-period, she said, there would be five additional deaths, four additional heart attacks and three additional episodes of heart failure.

The FDA in November added a heart-attack warning [2] to Avandia's label, but said the evidence linking the diabetes drug to heart attacks was inconclusive. Actos' label is free of the heart-attack language. The new study won't change the agency's recommendations, the FDA said in a statement.

GlaxoSmithKline, Avandia's manufacturer, said the new data is flawed because the patients using the drug typically were those who'd failed other treatments, and so they were sicker to start with.

- check out GSK's release [3]
- read the Chicago Tribune report [4]
- see this report [5] The New York Times
- read the JAMA study abstract [6]

Related Articles:
Study: Avandia breaks down bones. Report [1]
New Avandia warning 'a muddle'. Report [2]
Avandia warning, comeback imminent? Report [7]
Avandia cleared FDA by one vote. Report [8]