Los Angeles, CA.- Despite expert testimony about its side effects risk, a Food and Drug Administration advisory committee has recommended that the diabetes drug Avandia should be allowed to stay on the market. But while the committee did not call for an Avandia recall, it says that the drug's label should carry a stronger warning about its risk of causing heart disease.
The FDA convened the advisory committee meeting after a study published in the New England Journal of Medicine found that patients taking Avandia were 64% more likely to die from heart problems and 43% more likely to suffer a heart attack than other patients. The agency also ordered GlaxoSmithKline, the drug's manufacturer, and the maker of Actos, another diabetes drug, to add a "block-box" warning to their labels to alert patients of the drugs' potential for causing congestive heart failure.
During the advisory committee meeting on the side effects of Avandia, Dr. David Graham said that the diabetes drug was no more effective at controlling a patient's symptoms than other drugs. Because the drug could also increase the risk of heart attack, he called on the panel to recommend an Avandia recall.
Dr. Robert Ratner, an expert on diabetes, said that there was little proof that diabetes medications like Avandia caused much improvement in the long-term health of diabetes patients who used them. He said that because about 70% of diabetes patients die from heart disease, drugs like Avandia-which could increase the risk of heart attack-were not the most effective means of controlling diabetes symptoms.
However, in spite of expert testimony about the risk of Avandia side effects, the FDA's advisory committee decided that there was not enough evidence to issue an Avandia recall. However, testimony on the side effects of Avandia did convince the committee to recommend strengthening warnings about the risk of heart problems. The committee also advised doctors not to prescribe Avandia to patients who are at high risk of heart problems.
Avandia is one of a class of diabetes drugs known as thiazolidinediones (TZDs), which are designed to treat type-2 diabetes by increasing a patient's sensitivity to insulin. The FDA has linked TZDs to an increased risk of fluid retention, which could worsen or cause heart failure. In 2000, the agency asked the manufacturer of the TZD Rezulin to take it off the market because it caused more liver problems than either Avandia or Actos.
While the advisory committee fell short of calling for an Avandia recall, it told Glaxo that its existing clinical trial data did not provide enough evidence to counter the side effects risk outlined in the NEJM study. It told the company that more studies were needed in order to assess the true heart risks caused by Avandia. Although these studies have yet to be completed, preliminary data from Glaxo's RECORD clinical trial has led some scientists to suggest that the risk of Avandia side effects may be even greater than reported in the NEJM study.
Since the studies release, the FDA says that it has received hundreds of reports of heart attacks or hospitalizations due to heart problems among Avandia patients. Several Avandia deaths have also been reported among patients in the U.S. and Canada. A number of these patients or their families have filed Avandia lawsuits against Glaxo, which allege that the company failed to properly warn patients of the risk of Avandia side effects.