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Mike Ferrara
Mike Ferrara
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Black Box Warnings For Diabetes Drugs Avandia and Actos – FDA Cracking Down

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After years of criticism that they were not doing enough about drug safety because of links to the drug companies, the Food and Drug Administration is changing its tune. First, the FDA refused to grant Merck & Co., Inc. (NYSE: MRK) approval of its pain medication Arcoxia because it was too similar to the withdrawn drug Vioxx. This, even though Arcoxia is sold in 63 foreign countries. The latest news is the FDA is going to require Glaxo Smith Kline to put a “black box warning”, the most severe and strongest warning, on its diabetes drug Avandia. Similarly, the same will apply to the diabetes drug Actos, manufactured by the Japanese company Takeda. Both companies dodged the bullet as ordering their drugs removed from the market was under consideration. The warnings, the most severe that prescription drugs can bear, stress the medicines may cause or worsen heart failure and that patients should be closely monitored.

For more information on this subject matter, please refer to the section on Defective and Dangerous Products.