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Consumer Group Seeks FDA Ban on Avandia

Public Citizen cites liver failure deaths, other risks of adverse events for diabetes drug

THURSDAY, Oct. 30 (HealthDay News) -- The diabetes drug Avandia should be banned in the United States because it can cause death from liver failure and poses many other life-threatening risks that greatly outweigh its benefits, the advocacy group Public Citizen said Thursday.

The group said it has identified 14 cases of Avandia-induced liver failure, including 12 deaths. The cases were found in the U.S. Food and Drug Administration's Adverse Event Reporting System.

Public Citizen's call for an FDA ban on Avandia (generic name rosiglitazone) comes as an American Diabetes Association/European Association for the Study of Diabetes working group unanimously advised against the use of the drug. The working group's statement appears in the current issue of Diabetes Care.

"The scientific evidence against Avandia is overwhelming," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a Public Citizen news release. "The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug."

Liver toxicity is the latest problem linked to Avandia. According to Public Citizen, the drug increases the risk of heart attack by about 40 percent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluid accumulation in the eye.

Use of Avandia declined after a study connecting the drug with increased heart attack risk was published in New England Journal of Medicine in May 2007. The number of people taking Avandia declined from a peak of 13.2 million in 2006 to 4.6 million for the last full year. That means that about 10,000 prescriptions a day are still being filled for the drug, Public Citizen said.

The group said safer, more effective drugs for type 2 diabetes included metformin (brand name Glucophage) and glipizide (brand name Glucotrol). Pioglitazone (brand name Actos) isn't recommended, because it shares most of Avandia's toxicities, with the exception of heart attack risk.

Avandia is sold by GlaxoSmithKline. In a statement, the company said that it had not yet looked at the petition but said that "we do not believe there is a connection between liver toxicity and this medicine," the Wall Street Journal reported Thursday. Avandia was safe and effective when used appropriately, the company added.

An estimated 20.4 million Americans have type 2 diabetes, which can lead to kidney failure, blindness and heart disease. About 75 percent of diabetics die from cardiovascular disease.

In July, an FDA advisory panel said drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems. They recommended that all makers of these drugs conduct long-term cardiovascular trials, even if the drugs show no signs of heart problems in initial trials.

Most of the outside experts on the panel also said that trials assessing cardiovascular risk should be done before a drug is approved, perhaps as part of a phase III trial, to rule out any significant heart risk. Long-term trials could follow once the drug was on the market.

Currently, the FDA only requires that drugs for type 2 diabetes lower blood sugar, which is believed to protect diabetics from the debilitating side effects of the disease.

More information

Consumers Union has more about diabetes drugs.

-- Robert Preidt

SOURCE: Public Citizen, news release, Oct. 30, 2008

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