Debate about Avandia heart risks continues

By Austin Kirk
Posted June 26, 2007

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Yesterday at the annual meeting of the American Diabetes Association in Chicago, the debate about heart risks associated with Avandia was a main topic.  Concerns have been widespread among diabetes patients and doctors about an increased risk of heart attacks and heart related death since a study was published last month in the New England Journal of Medicine. 

INFORMATION: Avandia heart problems

Avandia is a popular medication which is prescribed for treatment of Type 2 diabetes.  An analysis of data from 42 different clinical trials showed that Avandia side effects lead to a 43% increase in the risk of heart attacks and a 64% increase in the risk of cardiovascular death.  Since the report was released, congressional hearings have been held about Avandia , the FDA has requested a stronger warning about heart problems and sales of the drug have plummeted.

The author of the New England Journal of Medicine study, Dr. Steven Nissen, a cardiology chief at the Cleveland clinic, spoke in support of his analysis at the meeting of approximately 13,000 medical researchers and physicians.  While some argued that the analysis should not have been released, Dr. Nissen indicated that it would have been unacceptable to keep the scientific community in the dark about the potential Avandia heart risks.

Questions have been raised about the strength of the study’s conclusions, since the trials analyzed were not designed to look at heart attacks.  There is an on-going randomized clinical trial known as Record, which is specifically examining the risk of Avandia heart problems.  However, there are questions about whether that study will ever be able to reach a conclusion since many of the patients enrolled have withdrawn.

The FDA has scheduled an advisory panel meeting for July 30 to review the issue of Avandia heart risks and determine what steps should be taken to protect consumers.  The FDA usually follows the recommendations of their advisory committees, though they are not required to do so.  Many experts and industry watch groups have criticized the FDA for ignoring early data linking Avandia to heart problems when they were considering approval of the drug.

AVANDIA HEART ATTACK LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing potential Avandia lawsuits for users who have experienced a heart attack, congestive heart failure, stroke or heart related death.  To determine if an injury may have been caused by Avandia, request a free claim evaluation.