Avandia Risks Reaffirmed by Canadian Study

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December 12th, 2007

"Journal of the American Medical Association reaffirms previous findings about the diabetes drug Avan"

A new study published in the Journal of the American Medical Association reaffirms previous findings about the diabetes drug Avandia—that is, it carries a significantly increased risk of heart failure, heart attack, and death.

Observational Study

The study involved 159,000 patients over the age of 65 who were treated for Type 2 diabetes under the government-run healthcare system in Ontario. Avandia was used in the treatment of 2,268 of those patients.

According to the findings, Avandia increased the risk of heart failure by 60 percent, the risk of heart attack by 40 percent, and death by 30 percent compared to patients taking similar diabetes drugs.

“Our study suggests that at least in this high-risk population, the harms of the drug may outweigh the benefits,” said Dr. Lorraine L. Lipscombe, lead author of the study.

Reaffirms Findings of May Study

Earlier this year, an analysis was published in the New England Journal of Medicine that suggested a 42 percent increased risk of heart attack among Avandia users. Sales of Avandia subsequently dropped, but the drug has remained on the market.

Avandia now carries a strengthened warning—a bold black box—but after a review, the Food and Drug Administration said evidence regarding the increased risks was inconclusive.

This new study could rekindle the debate over the safety of the drug.

“As you accumulate more and more evidence that Avandia has this problem, and it involves a very serious consequence, namely heart attack and death, it puts a lot of pressure on the FDA to do more,” said Dr. Steven E. Nissen, author of the May study.

(Source: New York Times online)

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