UPDATE: 9/23/10 New York Times FDA restricts use of Avandia in U.S. while EU bans it entirely
On August 14, 2007, the U.S. Food and Drug Administration (FDA) announced that the makers of Avandia® and Actos® will place more prominent black box warnings on their labels advising doctors and patients of the increased risks for heart failure and other cardiovascular problems.
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On June 5, 2007, the FDA requested the makers of Avandia® (manufactured by GlaxoSmithKline) and Actos® (manufactured by Takeda Pharmaceuticals/Eli Lilly & Company), to place more prominent warnings on their labels. The special warnings, also called “Black Box” Warnings, advise doctors and Type 2 diabetes patients of increased risks for heart failure and other cardiovascular problems.
The drugs are also known by their generic names rosiglitazone (Avandia®) and pioglitazone (Actos®).
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Dr. Steven E. Nissen and Dr. Kathy Wolski of the Cleveland Clinic, conducted a study analyzing the results of 42 previous studies of Avandia® involving 27,843 participants. Dr. Nissen is the chief of cardiovascular medicine at the Cleveland Clinic.
In May 2007, the results of the study were placed on the website of the New England Journal of Medicine. According to the New York Times (May 22, 2007), the study showed that Avandia® significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo. In an interview, Dr. Nissen estimated that “tens of thousands of people” may have had heart attacks as the result of taking the drug.
Additionally, while attempting to expand use of Avandia®, GlaxoSmithKline conducted its own 5,000-patient study which revealed that patients using Avandia® had 66% more heart attacks, 39% more strokes, and 20% more deaths from cardiovascular-related problems compared with a placebo.
Actos® by Taketa Pharmaceuticals/Eli Lilly & Company, a diabetes drug similar to Avandia®, is a close competitor of Avandia® and has also been considered to carry some risk of problems, including heart failure.
Both Avandia® and Actos® are members of a class of drugs with a difficult and troubling history. One drug in this group, Rezulin®, was withdrawn in 2000 because it caused liver failure and other serious medical problems.
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Some of the serious conditions that have been reported as a result of using Avandia® or Actos® to treat type 2 diabetes are:
If you or a loved one experienced any of the conditions above as the result of using Avandia® or Actos®, you may be entitled to compensation for:
In recent years, Kershaw|Cook|Talley’s pharmaceutical lawyers have litigated and settled numerous nationwide cases involving products such as:
If you think you developed heart failure, heart attack, stroke, or any other cardiovascular medical condition as the result of using Avandia® or Actos® to treat type 2 diabetes, the experienced personal injury attorneys of Kershaw|Cook|Talley can help. Please fill out and submit the contact form on this page for a free and confidential case evaluation or call us toll-free at (888) 997-5170.