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FDA Rejects Conclusions Made in Avandia Study PDF Print E-mail
Tuesday, 20 July 2010 00:35
Avandia is a diabetes medication that is manufactured by GlaxoSmithKline, and for years it dominated the market and was used widely by people who needed help keeping their type 2 diabetes under control.  Unfortunately for many people, reports of serious Avandia side effects eventually began to surface, drawing the attention of Avandia side effects lawyers across the country and the FDA.  Ultimately, it was decided that a federal panel of experts would decide whether Avandia would remain on the market.  In furtherance of this discussion, several studies were commissioned.  Below is an overview of the study and the FDA's reaction to it on the day before these discussions begin.  

The RECORD Study of Avandia Side Effects

The RECORD study has been touted as the largest study ever done in regards to Avandia side effects.  The study tracked more than 4,400 diabetics, some of whom took Avandia and others who took two older diabetes drugs, metformin and sulfonylurea.  The purpose of the study was to draw a comparison between the development of commonly alleged Avandia side effects - heart attacks, strokes and other pulmonary problems - in those who used Avandia and those who used the other drugs.  The conclusion of the RECORD study has been published, and it basically states that there is no link between the use of Avandia and an increased risk of heart disease, heart failure, and other alleged Avandia side effects.

 

The FDA's Reaction to the RECORD Avandia Side Effects Study

The FDA received and reviewed the conclusions of the RECORD study, and its response was basically to excoriate the results.  Using candor that's rare for this regulatory body, a spokesperson for the FDA noted that RECORD used sloppy data, failed to follow up on reports of the development of potential Avandia side effects and that overall the study was biased and inappropriate in several ways.  This reaction comes just one day before the process of deciding whether or not Avandia will remain on the market begins.

Unfortunately for many people who have already suffered from dangerous Avandia side effects, the decision regarding whether it remains on the market will not undo the damage already done.  If you or someone you love has suffered as a result of using this medication, you need to contact the Avandia side effects lawyers at Atkins & Markoff immediately to schedule a free initial consultation.


Oklahoma City Attorney
Written on Tuesday, 20 July 2010 00:35 by Oklahoma City Attorney

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