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Group calls on FDA to recall Avandia over liver dangers

July 25th, 2009

A leading consumer advocacy group has called on the Food and Drug Administration to recall the diabetes drug Avandia because it may cause liver failure and death. Public Citizen issued a previous call to ban Avandia in October 2008 over concerns that the drug could increase the risk of heart attack and death.

In a study published in the journal Pharmacoepidemiology and Drug Safety, Public Citizen wrote that an analysis of FDA Adverse Event Reports had uncovered 11 deaths caused by liver toxicity among Avandia patients. Because of the small percentage of adverse events that are actually reported to the FDA, Public Citizen said, this likely represent only a small percentage of the total number of liver side effects cases caused by Avandia.

Concerns about the safety of Avandia first arose in May 2007, when a study published in the New England Journal of Medicine found that patients taking Avandia were at an increased risk of heart attack or heart-related death. The study found that Avandia users were 64% more likely to die from heart problems and 43% more likely to suffer a heart attack than other patients.

Public Citizen says that it has also uncovered at least 10 deaths from liver failure linked to another diabetes drug, Actos. Although the drug has not been linked to an increased risk of heart attacks, research has associated Actos with an increased risk of heart failure.

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