March 2016Volume 22, Issue 3, Page 46
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FDA: Sexual enhancement supplements for men often tainted
Loren Bonner

FDA estimates that more than 200 million Americans take dietary supplements. However, many consumers—and even some health care providers—don’t realize that supplements are not regulated or approved by FDA.
High doses of undeclared drug ingredients—many that are dangerous—often lurk in these products, according to FDA. “You can’t tell for sure what’s in them, and more often than not, there are huge amounts and random combinations [of drugs] that have never been studied for safety or efficacy,” Lyndsay Meyer, press officer for FDA, told Pharmacy Today.
Sexual enhancement supplements are one of the largest categories of dietary supplements that have been tainted with active pharmaceutical ingredients or analogues.
FDA’s Medication Health Fraud website (see sidebar) lists all the reported products that have been tainted. Many sexual enhancement products for men contain both tadalafil (Cialis—Lilly) and sildenafil (Viagra—Pfizer). In lab tests, FDA found that nearly 300 of these products contain undisclosed drug ingredients.
Meyer said that one product FDA tested contained 100 times the proper dose of Viagra in combination with tadalafil and Prozac.

FDA steps up
FDA can take action if a product is unsafe by issuing public warnings, banning it, taking legal action, or working with the company to recall the product.
FDA issues alerts about ED supplements on a regular basis. In one recent warning, for example, FDA advised consumers not to purchase or use Wonder-Erect Male pills or gum. FDA analysis found vardenafil (Levitra—Bayer), which is known to interact with nitrates found in certain prescription drugs.
To adequately address the growing issue of tainted products on the market, FDA announced in late December 2015 the creation of a new Office of Dietary Supplement Programs (ODSP).
“Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry,” FDA said in a statement.
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FDA tips on dietary supplements
Stay informed.
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Understand that dietary supplement companies do not need FDA approval before marketing their products. Invest some time to learn more about FDA’s dietary supplement regulations (www.fda.gov/Food/DietarySupplements/).
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Review the list of FDA-identified tainted sexual enhancement products on FDA’s Medication Health Fraud website (www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Me...). FDA cannot test all sexual enhancement products on the market. Products that are not listed are not necessarily safe.
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Subscribe to FDA’s Tainted Products Sold as Dietary Supplements e-mail alerts to receive updates (www.fda.gov/Drugs/ucm136245.htm).
Talk to your patients.
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Ask about herbal supplement use. Sexual enhancement products may be a sensitive topic, so remain professional, unbiased, and nonjudgmental. Initiate this conversation to properly identify and monitor potential interactions with your patient’s prescription drug regimen.
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Emphasize that dietary supplements are not regulated by FDA like prescription medications are. This means their safety and efficacy have generally not been reviewed by FDA.
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Explain that statements such as “all-natural” or “herbal” can be misleading and that sexual enhancement products may contain undisclosed drug ingredients that could cause harm.
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Urge patients to submit a report to FDA’s Safety Reporting Portal (www.safetyreporting.hhs.gov) if they experience adverse reactions to dietary supplements.

Pharmacists taking action
Pharmacists can be alerted to these products either by joining ConsumerLab.com or by checking FDA’s MedWatch website. “I always highlight that ED products that are bought over the Internet from a company that is not a well-known quality brand such as GNC, Puritan’s Pride, etc., and that actually works, probably has been adulterated with sildenafil or a derivative,” said Anne Hume, PharmD, FCCP, BCPS, professor of pharmacy at University of Rhode Island College of Pharmacy.
ConsumerLab.com is one of two independent laboratories that routinely tests supplements and publishes the findings. Another company is LabDoor.com. Information can be found on their websites.
If pharmacists become aware of potentially tainted products, Hume advises reporting them to FDA.
Loren Bonner, MA, Reporter
© 2016 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

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March 2016Volume 22, Issue 3, Page 46

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