The diabetes drug Avandia has been linked with weight gain and fluid retention, both of which can lead to or aggravate congestive heart failure, according to the Food and Drug Administration. GlaxoSmithKline makes and sells Avandia for the treatment of patients with type 2 diabetes.

Three days ago, the agency announced that it has updated the warnings section of Avandia’s label to focus attention on the drug’s cardiovascular risk. Because of the danger of side effects of Avandia, patients in the cardiac status of class III or class IV cardiac should not take the drug, according to the FDA.

The FDA has called on physicians to be alert for symptoms of cardiac failure in patients who are taking Avandia. Rapid weight gain, fluid retention and shortness of breath are three main side effects Avandia, not to mention heart problems.

In September 2001, the company was under pressure from the FDA, so it sent out a dear-doctor letter warning that patients who are treated with Avandia and insulin therapy are at an elevated risk of heart failure.

Avandia has a cousin, another diabetes drug, Rezulin, which was pulled in 2000 after being linked to almost 100 cases of liver failure. Because of this, the FDA is also advising patients who are on Avandia to have frequent liver enzyme tests to assess their vulnerability to liver failure.

An article in the Annals of Internal Medicine showed some cases of liver problems among Avandia patients. Later in 2000, the FDA criticized GSK for claiming that the risk of liver failure in Avandia patients was lower than it actually was. The company was subsequently compelled to update its labels for the drug to show the true risk of the side effects of Avandia.