JAMA Admits 30% of Drugs Approved by FDA-Approved Are Seriously Dangerous

By Annabelle Bamforth

Close to one-third of drugs approved by the FDA are found to have safety problems, according to a research report from The Journal of the American Medical Association.

JAMA’s report stated that these safety issues, known as “postmarket safety events,” are “common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

The study sought to identify the “frequency of postmarket safety events” of FDA-approved drugs. It revealed that 222 “novel therapeutics” were approved by the FDA between 2001 and 2010. Out of those 222 FDA-approved products, there were 123 safety issues later found in 71, or 32 per cent, of the approved drugs. Actions taken for the 71 drugs included withdrawal of the substance, new safety announcements highlighting discovered risks, and issuing “black box” warnings.

These safety problems “were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval,” according to the report.

via JAMA Admits 30% of Drugs Approved by FDA-Approved Are Seriously Dangerous

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