SUPPLEMENTS TAINTED WITH PRESCRIPTION DRUGS OFTEN NOT RECALLED

A recent investigation found over-the-counter supplements for weight loss, muscle building, and erectile dysfunction are often adulterated with prescription medications and banned substances.  These types of supplements have been found to be responsible for a disproportionate number of the estimated 23,000 annual emergency department visits in the United States.

Supplements, unlike medications, do not have to be proven safe and effective before going to market.  The US Food and Drug Administration (FDA) only investigates supplements after adverse health consequences have been reported.  The FDA maintains a public database listing the supplements it has identified as adulterated with drugs and the actions, if any, it has taken to remove the product from the market.  This recent research report specifically found that from 2007-2016, the FDA logged 776 dietary supplements as being adulterated with prescription pharmaceuticals but that less than half of those products were recalled. And, all of these recalls were voluntary.  That means that it was recommended the manufacturers making the tainted products recall them, but it was not mandated nor enforced.  Other studies report companies often do not comply with recommended recalls and that dangerous products continue to be sold long after recalls are issued.  

Tainted supplements can be dangerous for consumers.  For example, 81% of erectile dysfunction supplements listed in the FDA’s tainted supplement database contained sildenafil, the active ingredient in Viagra. Some men cannot take erectile dysfunction drugs because their active ingredients interact dangerously with the nitrates in drugs for diabetes, high blood pressure, and high cholesterol.  The list of prescription medicines in the 776 contaminated supplements included prescription medications sildenafil and fluoxetine (anti-depressant), withdrawn medications including sibutramine (weight loss medication that increases heart health risk) and phenolphthalein (carcinogenic laxative), and unapproved drugs including dapoxetine (for erectile dysfunction) and anabolic and other designer steroids. 20% of the adulterated supplements contained two or more undeclared drugs! 

What to do:  Everyone, but especially those who are taking multiple medications or have serious health problems need to discuss supplements with their health provider before starting.  When choosing a supplement brand, look for those certified by “USP” (the U.S. Pharmacopeial Convention) or “NSF International”.  These third party organizations conduct testing on supplements to determine if what is on the label is actually in the bottle, and that the product does not contain high levels of contaminants. Websites such as Labdoor.com and Consumerlabs.com publish lists of the highest quality supplements. Also, generally, dietary supplements made by nationally known food or drug manufacturers are more likely to have been made under tighter quality controls. Supplements that contain a single ingredient have been found to be more likely to contain the amount of the ingredient advertised on the label and less likely to have high levels of contamination. Companies selling “proprietary blends” do not have to report any ingredient amounts on their labels and should be avoided.  All in all, given the risks of some classes of supplements and the general lack of evidence of their benefit, it is likely consuming a healthy diet will improve your health much more than expensive supplements.

Adapted from articles available at:

https://www.the-scientist.com/news-opinion/hundreds-of-supplements-spiked-with-pharmaceuticals-64928

https://www.sciencenews.org/article/hundreds-dietary-supplements-tainted-potentially-harmful-drugs

Sources:
Cohen PA.  Hundreds of supplements spiked with pharmaceuticals - Invited commentary.  The FDA and adulterated supplements—Dereliction of duty.  JAMA Network Open. 2018;1(6):e183329. doi:10.1001/jamanetworkopen.2018.3329

Geller  AI, Shehab  N, Weidle  NJ,  et al.  Emergency department visits for adverse events related to dietary supplements.  N Engl J Med. 2015;373(16):1531-1540. doi:10.1056/NEJMsa1504267PubMedGoogle ScholarCrossref

Tucker  J, Fischer  T, Upjohn  L, Mazzera  D, Kumar  M.  Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings.  JAMA Netw Open. 2018;1(6): e183337. doi:10.1001/jamanetworkopen.2018.3337Google Scholar

US Food and Drug Administration.  FDA’s Medication Health Fraud Page.  Accessed 10/25/18 at:  https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=1d&sd=tainted_supplements_cder&page=1