Avandia Side Effects

GlaxoSmithKline’s diabetes drug Avandia was intended as a safer alternative to Rezulin, another diabetes medication which was pulled from the market in 2000 after it was linked to nearly 100 cases of acute liver failure.

FDA issues first warning
The FDA issued a warning in 2002 that Avandia could cause fluid retention and lead to or aggravate the risk of congestive heart failure. Because of its similarities to Rezulin, patients taking Avandia were also advised to get liver enzyme tests in order to guard against cases of liver failure.

But the first real indication of the Avandia side effects came in May 2007 when a study revealed that people taking Avandia were 64% more likely to die of heart problems and 43% more likely to suffer heart attacks.

158 heart attacks, 61 deaths
The study uncovered a total of 158 heart attacks and 61 deaths among Avandia patients. It prompted the FDA to issue a “black-box” warning for Avandia in early June 2007.

However, because the clinical trials examined in the NEJM were only short-term studies, researchers say that the risk of heart problems among Avandia patients may be even higher than their results indicated.

Dr. David Nathan, the chief of diabetes care at Massachusetts General Hospital, agreed that the study may only hint at the true risk of heart problems and other Avandia side effects. “This analysis is just scratching the surface of what may be there,” he says. “It needs to be taken seriously.”

In November 2007, the FDA added a second black box warning to Avandia's label, warning patients that the drug could increase their risk of heart attack or chest pain.

Weak monitoring of Avandia’s safety
Other doctors who have reviewed the study have criticized the FDA and GSK for their weak monitoring of Avandia’s safety. Some have compared the FDA’s monitoring of the risk of Avandia side effects with its handling of another drug, Vioxx, which was withdrawn in 2004 after being linked to an increased risk of heart attacks and other problems.

The 43% increased risk of heart attack with Avandia is similar to the heart attack risk with low doses of Vioxx. As if that were not enough, the ADOPT study found that women who take Avandia are at an increased risk of suffering bone fractures.

Patients taking Avandia should watch for unusually rapid weight gain, fluid retention (edema), shortness of breath and other symptoms of heart failure. The first of what is sure to be numerous Avandia lawsuits was filed in June 2007 in U.S. district court.