Glaxo Gets Some Good News

The editorial writers say "the cumulative beneficial effects of TZDs over time exceed their major shortcoming ... namely detectable fluid retention in less than 10% of heart failure patients." Such problems can be controlled by discontinuing the medication or by careful monitoring by heart specialists, they say. Fluid retention can lead to congestive heart failure.

Restricting or denying a drug to the 90% of patients who might benefit from TZDs because fewer than 10% have "adverse" side effects "is not shrouded in wisdom," say the editorial writers, who are cardiovascular specialists at Ohio State.

The cardiology journal says editorials don't necessarily reflect its views or those of its parent, the American College of Cardiology. Soon after the NEJM article was published on May 21, the cardiology group joined with the American Diabetes Association and the American Heart Association to recommend doctors use caution with Avandia.

"The overall level of the risk associated with [Avandia] appears to be small but nonetheless one that must be considered carefully," they said.

Glaxo has disputed the NEJM research, and its executives have defended Avandia's safety in comments to Congress and the public. The company says Avandia's heart risks are comparable to those of other oral diabetes medications.

Still, Glaxo does say its drug increases the chance of congestive heart failure -- a more serious condition that also reduces the heart's pumping ability. It says patients with congestive heart failure shouldn't start or continue with Avandia or any TZD.

The FDA didn't order any immediate changes in the drug's label, although it did tell doctors to exercise caution. However, FDA Commissioner Dr. Andrew von Eschenbach recently said he favors adding the strictest warning label for these drugs. Takeda has already said it is working on preparing a black box for Actos.