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Watchdog Group Petitions FDA to Ban the Diabetes Drug Avandia
November 3, 2008
On October 30, 2008, the consumer group Public Citizen asked the U.S. Food and Drug Administration to ban the formerly popular diabetes drug Avandia, claiming the drug’s life-threatening risks greatly outweigh its benefits. In addition to the risk of heart attack, which is already cited in a "black box" warning on Avandia's label, Public Citizen said it identified 14 cases of liver failure associated with Avandia. The consumer advocacy group also said that a review of adverse-event reports filed with the FDA indicated that 12 of the 14 cases resulted in liver-related deaths.
Avandia, which has the generic name rosiglitazone, is an oral medication prescribed to treat type 2 diabetes mellitus, “adult-onset� or “non-insulin dependent� diabetes. It is manufactured by GlaxoSmithKline and has been on the market since 1999.
Public Citizen's petition for an FDA ban on Avandia came at the same time as leading medical groups in the U.S. and Europe started calling on doctors not to use the former top-selling drug. Specifically, a consensus statement recently issued by the American Diabetes Association and European Association for the Study of Diabetes unanimously advised against using Avandia. Although the medical groups said they are not clear whether Avandia is associated with cardiovascular risks, they stated that safer options are available.
According to Public Citizen, safer, more effective drugs for type 2 diabetes include metformin (brand name Glucophage) and glipizide (brand name Glucotrol). Public Citizen does not recommend taking Pioglitazone (brand name Actos) because it shares most of Avandia's health risks, except the risk of heart attack.
Currently, the FDA says it is conducting a careful review of Public Citizen’s petition to pull Avandia from the market. In making its final decision, the FDA must resolve a split within the agency about whether to pull Avandia off the market or allow it to stay but with stronger warnings.
Avandia Side Effects Attorney
If you or a loved one took Avandia and experienced serious side effects, such as heart attack or liver failure, you may be entitled to compensation for your injuries. Contact us today for a free and confidential case evaluation from one of our experienced Avandia side effects attorneys.
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