Over the previous decade, the Food and Drug Administration (FDA) has issued a gentle stream of public warnings about dietary dietary supplements which were spiked illegally with hidden drug elements or contaminated with different probably harmful substances. Among the pharmaceutical ingredients most frequently detected by the FDA in such merchandise have been the lively components present in prescribed drugs for treating erectile dysfunction, comparable to sildenafil (Viagra) and tadalafil (Cialis). These merchandise sometimes are promoted as containing “all-natural” components for male sexual enhancement.
Unsurprisingly, the FDA is beginning to discover unlawful dietary dietary supplements that include flibanserin, the lively ingredient within the prescription drug Addyi, which was approved by the FDA in August 2015 for treating premenopausal women with hypoactive sexual want dysfunction. On April 18, the FDA announced that the company’s evaluation had detected flibanserin in two merchandise — Zrect for Women and LabidaMAX — and that the corporate making these merchandise — Organic Herbal Supply, situated in Roseville, CA — was voluntarily recalling them. The FDA famous that these dietary supplements had been bought nationwide via Amazon.com and thru Zrect.com beginning on or round December 2014 by way of February 2017.
Similar to the best way that dietary supplements with hidden erectile dysfunction medicine have been promoted to males, these flibanserin-tainted dietary supplements have been being promoted for sexual enhancement in women. For instance, one ad for Zrect for Women boasts that the product “[i]ncreases a wom[a]n[’]s libido and sexual desire.”
Consumers unwittingly consuming flibanserin are uncovered to a big danger of great hurt. Importantly, the product labeling for the prescription drug Addyi carries a black-box warning — the strongest sort of warning required by the FDA — stating that the drug may cause extreme drops in blood strain and fainting, which may end up in critical, irreversible and even life-threatening accidents.
Women who mix alcohol with flibanserin, who take different medicine that may intrude with the physique’s breakdown of flibanserin, or who’ve liver illness have the best danger of those hostile occasions. The product labeling for Addyi additional cautions that sufferers taking flibanserin must not ever mix it with alcohol as a result of the hazard of doing so is just too nice. Moreover, physicians who prescribe, pharmacies that dispense and corporations that distribute Addyi should adjust to a number of particular necessities imposed by the FDA when it accredited the drug.
On June four, 2015, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, testified earlier than two FDA advisory committees to induce the company to reject flibanserin, because it had in 2010 and 2013. He argued that the life-threatening risks of the drug far exceeded its minimal profit: Clinical trials had proven that sufferers utilizing flibanserin had a mean of just one half to at least one further sexually satisfying expertise per thirty days in contrast with sufferers taking a placebo (see FDA assessment here).
Zrect for Women and LabidaMAX undoubtedly are simply the primary of many unlawful flibanserin-spiked dietary dietary supplements that might be promoted to spice up women’s sexual drive by unscrupulous corporations around the globe. And as historical past has proven with dietary supplements promoted to spice up males’s sexual drive that include erectile dysfunction medicine, the FDA will continuously be enjoying catch-up to take away these merchandise from the market solely after many unsuspecting shoppers have been positioned in hurt’s means.
Consumers can greatest shield themselves by by no means utilizing dietary dietary supplements marketed for sexual enhancement. The common shopper just isn’t capable of distinguish these dietary supplements that really include solely pure elements from these tainted with lively pharmaceutical elements. Moreover, there isn’t any proof that the previous work, and the latter are just too harmful.
Read extra in Public Citizen’s May Health Letter.