Following years of testing and controversy, the U.S. Food and Drug Administration (FDA) may be moving closer to taking action on the popular diabetes drug Avandia®.
After an advisory committee meeting and a hold on manufacturer GlaxoSmithKline’s TIDE trial, the FDA has stated that it is evaluating information on Avandia’s safety. The FDA will update the public on the outcome of this review, and its implications for Avandia®, when the review is complete.
In the intermediary, no new patients will be permitted to enroll in the TIDE safety study.
The meeting was held just weeks after the FDA concluded that Avandia® – the most popular diabetes drug in the world – increases the risk of heart attacks, strokes, and death (source: NPR).
Avandia’s safety has been in question since a 2007 article in the New England Journal of Medicine by Cleveland Clinic cardiologist Steven Nissen showed the product raised the risk of heart attacks by more than 40 percent.
In November of 2007, the FDA requested that GlaxoSmithKline put a “black box” warning on Avandia.
In February of this year the Senate Finance Committee accused the manufacturer of holding back data that shows problems with Avandia.
In May, studies in the Journal of the American Medical Association and the Archives of Internal Medicine stated that Avandia increases the risk of cardiovascular problems.
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Our law firm is currently investigating claims involving Avandia side effects. Contact our Avandia lawyers today to discuss your case.
To speak with one of our courtroom-seasoned personal injury attorneys, contact the Orlando law office of Frank M. Eidson, P.A., today and schedule a free consultation. We are presently investigating claims involving Avandia®.
In some studies, Avandia® has been linked to serious side effects. If you have been diagnosed with Avandia® side effects, our personal injury lawyers may be able to help. Contact Avandia-Lawyer.tv for a free consultation. Please bring any of the following information:
Please note: Talk to your doctor before taking any action. Do not discontinue your medication unless specifically directed by your physician. According to the FDA, “there is inherent risk associated with switching patients with diabetes from one treatment to another…”