Avandia Recall Watch: Study Questions Benefits of Diabetes Drug

Austin Kirk

By Austin Kirk
Posted November 13, 2008


Lately it seems that new information has emerged every week pointing towards a possible Avandia recall. A number of serious and life-threatening side effects have been associated with the drug, and this week new research raises concerns about the degree of benefit users of Avandia may receive.

>>INFORMATION: Avandia Lawsuits

At the annual meeting of the American Heart Association in New Orleans, researchers presented data from a study that compared Avandia to an older generic diabetes drug glipizide, measuring the differences in the buildup of heart artery plaque.

While the study was small in size, only involving 672 people, researchers indicated that Avandia provided no statistically significant reduction in the plaque buildup at 18 months compared with when the study started. Avandia did show a slight reduction, compared with a very small increase for those on glipizide, but researchers indicate that the difference between the two drugs was so small that it does not reach the threshold of statistical significance.

These findings may not normally have a huge impact on future sales for a drug, but in Avandia’s case, this could be one more nail in the proverbial coffin.

Last week the consumer group Public Citizen filed a petition with the FDA calling for an Avandia recall, stating that any potential benefits of the drug are now outweighed by the risks, which could include a heart attack, congestive heart failure, liver failure, bone fractures, vision loss or death.

In addition, the American Diabetes Association and the European Association for the Study of Diabetes removed Avandia from their list of recommended treatments for type 2 diabetes last month. As a result of the safety concerns surrounding Avandia, the groups unanimously advised against further use of the drug.

When concerns about a potential increased risk of heart attacks associated with Avandia surfaced last year, the FDA briefly considered removing the drug from the market. However, after a narrow vote, and heated internal debate within the agency, the drug regulators decided not to issue an Avandia recall, and instead placed a black box warning prominently on the label.

With the recent decision by the American Diabetes Association, the Public Citizen petition and these latest findings which question the extent of benefits provided by Avandia, hopefully the FDA will act quickly to reconsider whether the drug should still be available.


The Avandia lawyers at Saiontz & Kirk, P.A. are investigating potential cases for users of the diabetes drug who suffered:

  • Heart Attack
  • Liver Failure
  • Stroke
  • Heart Failure
  • Vision Loss, known as Macular Edema
  • Bone Fractures
  • Death

To review whether you, a friend or family member may be eligible for compensation through an Avandia lawsuit, request a free consultation and claim evaluation.

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