Hazards of Hindsight - Monitoring the Safety of Nutritional Supplements

New England Journal of Medicine (Impact Factor: 55.87). 04/2014; 370(14):1277-80. DOI: 10.1056/NEJMp1315559
Source: PubMed


Americans spend more than $32 billion a year on dietary supplements, which do not require premarketing approval before they reach store shelves. Under current law, the FDA must identify and remove dangerous supplements only after they have caused harm. 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. . . .

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