And the studies keep coming. 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 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
- read the Chicago Tribune report
- see this report The New York Times
- read the JAMA study abstract