A drug that is commonly prescribed to patients who have Type II diabetes may markedly increase their risk of heart attacks and even death, according to a new review study published in the online edition of this week's New England Journal of Medicine.
The study on the drug's side effects was rushed into circulation Monday by the journal. The new revelations are likely to leave the million or so patients taking the drug, Avandia, wondering what to do.
Type II is the most common type of diabetes.
Steven Nissen, head of the division of cardiovascular medicine at the Cleveland Clinic, started investigating the oral drug Avandia after noticing a suggestion of problems in a medical article published last autumn.
He and a statistician combined the results of 42 trials of the drug. They found that it increased the risk of heart attacks by 43 percent — and of death from heart problems by 64 percent.
Avandia manufacturer GlaxoSmithKline says that it did its own study, similar to Nissen's, which also found an increased risk. But Glaxo chief medical officer Ronald Krall says that combining many different studies and analyzing them for data they weren't designed to collect is an imperfect way to judge risk.
Krall says Glaxo has several other studies in which doctors looked for cardiovascular problems. He says those studies showed no problems.
There is already a mention of cardiovascular risk on the drug's label, but it is not highlighted. At an FDA press conference Monday, Robert Meyer said the new analysis raises concerns, but the agency has more work to do.
The FDA says it will hold a meeting within the next couple of months to ask its advisers whether further steps should be taken.