Avandia...? The Uncertainty Continues.

From the very day that Dr. Nissen’s meta-analysis was published on the NEJM associating Avandia to cardiovascular risks, one thing has remained unchanged till date. The issue was uncertain then and even today the uncertainty continues.

While the drug already has a black box warning for heart failure, as does its competitor Actos, and the FDA has asked that a warning about myocardial infarction be added to the existing warning on the label.

This warning however does not say anything categorically and reads thus:

"A meta-analysis of 42 clinical studies (mean duration six months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction," it said. "Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive."

Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, said the FDA is also asking that all oral antidiabetes drugs add this language to the drug labels: "To date, no oral antidiabetes drug has been conclusively shown to reduce cardiovascular risk."

Dr. Nissen, co-author of the meta-analysis that will be inscribed on the rosiglitazone label, said he was satisfied that the FDA added a new black box for ischemic heart disease, but he said the warning was "weakly worded and ambiguous."

There are a lot of questions with no answers and it might be a long time before someone eventually comes up with something conclusive. But till then diabetics around the world and the doctors treating them will remain in the dark.

Dr. Gregory Dehmer, professor of internal medicine at Texas A&M Health Science Center College of Medicine and director of the cardiology division at Scott & White Hospital in Temple summed it up wonderfully, "For the average clinician in the street, there's a substantial amount of uncertainty, and this is magnified for patients."

- D R Sudhakar