Hazards of Hindsight - Monitoring the Safety of Nutritional Supplements
ABSTRACT 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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ABSTRACT: Active pharmaceutical ingredients (APIs) from the purchase and use of medications are recognized as ubiquitous contaminants of the environment. Ecological impacts can range from subtle to overt - resulting from multi-generational chronic exposure to trace levels of multiple APIs (such as in the aquatic environment) or acute exposure to higher levels (such as with wildlife ingestion of improperly discarded waste). Reducing API entry to the environment has relied solely on conventional end-of-pipe pollution control measures such as wastewater treatment and take-back collections of leftover, unwanted drugs (to prevent disposal by flushing to sewers). An exclusive focus on these conventional approaches has ignored the root sources of the problem and may have served to retard progress in minimizing the environmental footprint of the healthcare industry. Potentially more effective and less-costly upstream pollution prevention approaches have long been considered imprudent, as they usually involve the modification of long-established norms in the practice of clinical prescribing. The first pollution prevention measure to be proposed as feasible (reducing the dose or usage of certain select medications) is followed here by an examination of another possible approach - one that would rely on the excretion profiles of APIs. These two approaches combined could be termed eco-directed sustainable prescribing (EDSP) and may hold the potential for achieving the largest reductions in API entry to the environment - largely by guiding prescribers' decisions regarding drug selection. EDSP could reduce API entry to the environment by minimizing the need for disposal (as a consequence of avoiding leftover, unwanted medications) and reducing the excretion of unmetabolized APIs (by preferentially prescribing APIs that are more extensively metabolized). The potential utility of the Biopharmaceutics Drug Disposition Classification System (BDDCS) is examined for the first time as a guide for API prescribing decisions by revealing relative API quantities entering sewage via excretion.Science of The Total Environment 06/2014; 493C:392-404. DOI:10.1016/j.scitotenv.2014.06.013 · 4.10 Impact Factor
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ABSTRACT: A synthetic stimulant never before studied in humans, 1,3-dimethylbutylamine (DMBA), was suspected of being present in dietary supplements. DMBA is an analogue of the pharmaceutical stimulant, 1,3-dimethylamylamine (DMAA), which was recently banned by the US Food and Drug Administration. We obtained all dietary supplements sold by US distributors that listed an ingredient on the label, such as AMP Citrate, that might be a marketing name for DMBA. Supplements were analyzed for the presence and quantity of DMBA. Fourteen supplements met our inclusion criteria and were analyzed by two separate laboratories using ultra high performance liquid chromatography (UHPLC) - mass spectrometry and a reference standard. The identity of DMBA was confirmed in 12 supplements in the range of 13 to 120 mg DMBA per serving. Following recommendations on the supplement label for maximum daily intake, customers would consume from 26 to 320 mg of DMBA per day. Supplements containing DMBA were marketed to improve athletic performance, increase weight loss and enhance brain function. DMBA has never before been detected in supplements. The stimulant has never been studied in humans; its efficacy and safety are entirely unknown. Regulatory agencies should act expeditiously to warn consumers and remove DMBA from all dietary supplements. Copyright © 2014 John Wiley & Sons, Ltd.Drug Testing and Analysis 10/2014; 7(1). DOI:10.1002/dta.1735 · 2.82 Impact Factor
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ABSTRACT: Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements.Nutrients 12/2014; 6(12):5392-5404. DOI:10.3390/nu6125392 · 3.15 Impact Factor