After publication of an article in the New England Journal of Medicine and a subsequent alert by the Food and Drug Administration, patients and doctors are on alert about the diabetes drug Avandia and its link to heart problems.

The research, conducted by Dr. Steven Nissen of the Cleveland Clinic and published in the NEJM, is not the first time Avandia has been linked to heart attacks. The European Medicines Agency turned it down for just this reason in 1999. An editorial that ran along with the NEJM article says Avandia is “a major failure of the drug-use and drug-approval process in the United States.”

The FDA has not yet asked GlaxoSmithKline to add warnings to Avandia’s label or to recall it. But it may do so at a later time. Instead, the agency urges physicians to make treatment decisions on an individual basis.

Although GSK has strongly disagreed with the study’s methodology and conclusions, Dr. Ronald Krall, the company’s chief medical officer, concedes that it knew about increased heart risks three years ago. He says GSK will not voluntarily recall Avandia.

Congressmen criticized the FDA for its delay in reporting the findings about Avandia. Rep. Henry Waxman has called a hearing for early June to determine the FDA’s role in evaluating the safety of Avandia. His colleague, Rep. Bart Stupak, says that Avandia may have unnecessarily risked the lives of thousands of Americans.

Vioxx, an arthritis drug, was withdrawn from the market in 2004 after it was found to double the risk of strokes and heart attacks. There were numerous Congressional hearings about FDA oversight and dozens of lawsuits against Merck as a result of the Vioxx issue.