Avandia to get Black Box Warning

posted on:
August 19, 2007

author:
Staff

 Rockville, MD: The U.S. Food and Drug Administration announced that Avandia, a controversial diabetes drug, will now carry a strong black box warning on its label. The new label will advise patients of the increased risk of heart failure associated with taking the drug. 

The warning label follows the release of studies that found using Avandia increases the risk of heart failure in some patients and increased criticism of the FDA's role in approving drugs. Meanwhile, lawsuits have already been filed against the maker of Avandia, alleging the company knew about the increased risks but failed to warn consumers, resulting in serious injury to some Avandia users.

Avandia's new warning label will emphasize that Avandia and the other drugs may cause or worsen heart failure in certain patients. The new warning recommends that doctors be on the alert for patients on Avandia who develop symptoms or signs of heart failure. Those symptoms include rapid weight gain, shortness of breath, and edema (swelling). Patients who develop symptoms and signs of heart failure should reconsider their use of Avandia and should seek treatment for heart failure. Heart failure is a condition that occurs when the heart does not adequately pump blood.

While reviewing post-marketing data, the FDA found reports of weight gain and edema associated with Avandia. According to the FDA's news release, in some incidents, "…continuation of therapy has been associated with poor outcomes, including death."

The FDA and GlaxoSmithKline, maker of Avandia, have been negotiating changes to the warning label since May. Four other diabetes drugs will also carry the black box warning. The affected drugs are Avandia, Actos, Avandaryl, Avandamet, and Duetact. All are thiazolidinedione antidiabetic drugs.

A black box warning is the most severe that prescription drugs can carry. This black box warning is separate from concerns that Avandia raises the risk of heart attack and strokes. The FDA has suggested that more research is needed on the alleged increased risk of heart attacks in patients who use Avandia. However, the FDA has allowed Avandia to remain on the market with a stronger warning and is continuing its review of the risk of heart attacks.

People in the United States are not the only ones following the Avandia story closely. In Canada, a class-action lawsuit was filed against GlaxoSmithKline, alleging users of Avandia were not sufficiently warned about the drug's risks. The lawsuit was filed at the end of July on behalf of a 75-year-old woman who died of a heart attack and on behalf of any members of the proposed class. That class includes all Canadians who took Avandia and suffered serious medical problems. The survivors of people who died while taking Avandia are also included in the class. The lawsuit also names the federal government as a defendant in the lawsuit because of its failure to respond appropriately when new information about Avandia became known.

Lawsuits have also been filed in the United States regarding Avandia and the failure of GlaxoSmithKline to inform users of the drug's risks.

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