Health Letter, May 2017
By Michael Carome, M.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
Over the past decade, the Food and Drug Administration (FDA) has issued a steady stream of public warnings about dietary supplements that have been spiked illegally with hidden drug ingredients or contaminated with other potentially dangerous substances. Among the pharmaceutical ingredients most frequently detected by the FDA in such products have been the active ingredients found in prescription drugs for treating erectile dysfunction, such as sildenafil (Viagra) and tadalafil (Cialis). These products typically are promoted as containing “all-natural” ingredients for male sexual enhancement.
Unsurprisingly, the FDA is starting to find illegal dietary supplements that contain flibanserin, the active ingredient in the prescription drug Addyi, which was approved by the FDA in August 2015 for treating premenopausal women with hypoactive sexual desire disorder. On April 18, the FDA announced that the agency’s analysis had detected flibanserin in two products — Zrect for Women and LabidaMAX — and that the company making these products — Organic Herbal Supply, located in Roseville, CA — was voluntarily recalling them. The FDA noted that these supplements had been sold nationwide through Amazon.com and through Zrect.com starting on or around December 2014 through February 2017.
Similar to the way that supplements with hidden erectile dysfunction drugs have been promoted to men, these flibanserin-tainted supplements were being promoted for sexual enhancement in women. For example, 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 exposed to a significant risk of serious harm. Importantly, the product labeling for the prescription drug Addyi carries a black-box warning — the strongest type of warning required by the FDA — stating that the drug can cause severe drops in blood pressure and fainting, which can result in serious, irreversible or even life-threatening injuries.
Women who combine alcohol with flibanserin, who take other drugs that can interfere with the body’s breakdown of flibanserin, or who have liver disease have the greatest risk of these adverse events. The product labeling for Addyi further cautions that patients taking flibanserin must never combine it with alcohol because the danger of doing so is too great. Moreover, physicians who prescribe, pharmacies that dispense and companies that distribute Addyi must comply with several special requirements imposed by the FDA when it approved the drug.
On June 4, 2015, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, testified before two FDA advisory committees to urge the agency to reject flibanserin, as it had in 2010 and 2013. He argued that the life-threatening dangers of the drug far exceeded its minimal benefit: Clinical trials had shown that patients using flibanserin had an average of only one half to one additional sexually satisfying experience per month compared with patients taking a placebo (see FDA review here).
Zrect for Women and LabidaMAX undoubtedly are just the first of many illegal flibanserin-spiked 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.
Consumers can best protect themselves by never using dietary supplements marketed for sexual enhancement. The average consumer 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.