Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements

Posted 16 September 2014

“Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.1 Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death. Nor have any changes been made to improve the FDA’s ability to detect dangerous supplements.”

Pieter A. Cohen, M.D.  Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements. N Engl J Med 2014; 370:1277-1280April 3, 2014

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