FDA Follies, Part 2

Part 1 of this series appeared just over a year ago (in a different publication), and detailed a few of the agency's recent missteps. Prominently mentioned was the sad case of certain diabetes meds, including Actos, once touted as a safer alternative to Avandia. Avandia was taken off the market in 2011, but reappeared subject to severe limitations of use. These limitations were later removed—although current usage of the drug is small. Oddly, Actos (FDA approved in July, 1999) was showing some problems (bladder cancer) as early as 2005, even though this information was not widely disseminated at the time. Some might even say it was suppressed, in that it was not disclosed in the original study. But, it did finally appear in 2009 and 2011. Meanwhile, in August, 2007, the FDA issued a "boxed warning" aka a "black box warning"—appearing on the drug's label, designed to call attention to serious or life-threatening risks—concerning Actos and other similar drugs. No worries, though. In 2008, Actos became the tenth best-selling drug in the US. In 2010 and 2011, whistle-blower lawsuits were filed against Actos' manufacturer Takeda, and more negative data came out on the drug. In June, 2011 the drug was banned in France and Germany. By the end of 2011, sources indicated that more than 10,000 Actos lawsuits would be filed against Takeda. But here's the best part: In August, 2012, the FDA approved a generic version of the drug. Wow, now you could da...
Source: Healthy Living - The Huffington Post - Category: Consumer Health News Source Type: news