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For years, the Food and Drug Administration (FDA) has repeatedly warned the public about dietary supplements that have been spiked illegally with hidden drugs. Among the drugs most frequently detected by the FDA in such products have been the active ingredients found in prescription medicines for treating erectile dysfunction, such as sildenafil (VIAGRA).[1] These products typically are promoted as containing “allnatural” ingredients for male sexual enhancement.
Unsurprisingly, the...
For years, the Food and Drug Administration (FDA) has repeatedly warned the public about dietary supplements that have been spiked illegally with hidden drugs. Among the drugs most frequently detected by the FDA in such products have been the active ingredients found in prescription medicines for treating erectile dysfunction, such as sildenafil (VIAGRA).[1] These products typically are promoted as containing “allnatural” ingredients for male sexual enhancement.
Unsurprisingly, the FDA now is finding illegal dietary supplements that contain flibanserin, the active ingredient in the prescription drug ADDYI, which was approved by the FDA in 2015 for treating premenopausal women with hypoactive sexual desire disorder.[2] On April 18, the FDA announced that flibanserin had been found in two products — Zrect for Women and LabidaMAX — and that the company making these products was voluntarily recalling them.[3] Similar to the way that supplements with hidden erectile dysfunction drugs have been promoted to men, these flibanserin-tainted supplements were being promoted for increasing sexual desire and libido in women.[4]
Consumers unwittingly taking flibanserin are at risk of serious harm. The product labeling for ADDYI has a black-box warning stating that the drug can cause severe drops in blood pressure and fainting,[5] which can result in serious, irreversible or even life-threatening injuries. Women who combine alcohol with flibanserin, who take other drugs that can interinterfere with the body’s breakdown of flibanserin or who have liver disease have the greatest risk of these adverse events. The labeling for ADDYI further cautions that flibanserin must never be combined with alcohol because the danger of doing so is too great.
Importantly, the dangers of flibanserin far exceed its minimal benefit: Clinical trials have shown that patients using the drug had an average of only one half to one additional satisfying sexual experience per month compared with patients taking a placebo.[6]
Zrect for Women and LabidaMAX undoubtedly are just the first of many illegal flibanserin-tainted dietary supplements that will be promoted to boost women’s sexual drive by unscrupulous companies around the world. And as history has shown with supplements promoted to boost men’s sexual drive that contain erectile dysfunction drugs, the FDA will constantly be playing catch-up to remove these products from the market only after many unsuspecting consumers have been placed in harm’s way.
You can best protect yourself by never using dietary supplements marketed for sexual enhancement. The average person is not able to distinguish those supplements that truly contain only natural ingredients from those tainted with active pharmaceutical ingredients. Moreover, there is no evidence that the former work, and the latter are simply too dangerous.
References
[1] Food and Drug Administration. Tainted sexual enhancement products. https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/medicationhealthfraud/ucm234539.htm. Accessed May 17, 2017.
[2] Sprout Pharmaceuticals. Label: flibanserin (ADDYI). August 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf. Accessed May 17, 2017.
[3] Food and Drug Administration. Organic Herbal Supply issue voluntary nationwide recall of all lots of various supplements for male and female sexual enhancement due to undeclared tadalafil and flibanserin. https://www.fda.gov/Safety/Recalls/ucm553631.htm. Accessed May 17, 2017.
[4] Living Healthy. Zrect for Women, natural libido enhancer, the pink pill. http://livinghealthysupply.com/product/zrect-for-women-natural-libido-enhancer-the-pink-pill/. Accessed April 21, 2017.
[5] Sprout Pharmaceuticals. Label: flibanserin (ADDYI). August 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf. Accessed May 17, 2017.
[6] Food and Drug Administration. FDA briefing document for joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee: NDA 022526 flibanserin. June 4, 2015. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf. Accessed May 17, 2017. PDF page 9.
