Biotech & Pharma
Health & Science
Exclusive analysis of biotech, pharma, and the life sciences
By Megan Thielking April 19, 2017
Following in the footsteps of its predecessor Viagra, the female libido drug Addyi has snuck into over-the-counter supplements that tout their ability to “naturally” enhance sexual desire.
The Food and Drug Administration announced a recall Wednesday of two supplements marketed to boost women’s sex drive. The supplements Zrect and LabidaMAX — both manufactured by Organic Herbal Supply — actually contained flibanserin, a medication approved by the FDA in late 2015 to treat hypoactive sexual desire disorder in women. It’s the first time federal officials have recalled a product contaminated with the drug.
“It’s the latest example of brand-new drugs being found in supplements,” said Dr. Pieter Cohen, a physician at Harvard Medical School who studies dietary supplements.
The problem has long plagued the male sexual enhancement supplement market. Viagra has turned up in dozens of over-the-counter pills that never declared they contained the drug. The FDA regularly checks supplements shipments for the presence of Viagra, and has added flibanserin into their scans since the drug was approved.
“FDA lab tests have found that hundreds of these products contain undisclosed drug ingredients,” said Lyndsay Meyer, a spokesperson for the agency.
The massive dietary supplement industry is largely unregulated. The products can be sold without a prescription in supermarkets, supplement stores, and, increasingly, online. The products currently being recalled were sold on Amazon through February.
And while supplement makers are not allowed to claim that their products cure or treat a particular condition, they are allowed to make general claims that their products support health or, in this case, promote sexual desire.
“There’s nothing that you can actually put into the pill that lives up to advertised claims, so there is this temptation to introduce a pharmaceutical drug that attempts to meet those claims,” said Cohen. Organic Herbal Supply, which is recalling its products, did not respond to a request for comment.
The FDA said it has not received any reports of adverse events tied to either of the supplements. But Cohen said they are far from safe — and argued a lack of regulation will allow those risks to remain.
“We have no idea the harms being caused by these products. As long as these products can be sold as if they improve your sexual health, there’s going to be no stopping this,” he said.
The amount of undeclared flibanserin in a supplement could vary widely from one pill to the next, as has been the case with Viagra. It’s also possible the drug could be introduced into a supplement along with other potentially libido-boosting compounds, exacerbating those effects.
“We don’t know what danger this poses because these combinations have never been studied before they’re sold to unsuspecting consumers,” Meyer said. Consumers can report adverse events tied to these or other dietary supplements to the agency online.
Cohen said the message from the recall is clear: “Consumers should just completely avoid sexual enhancement supplements. They either might be safe and don’t work, or they might work but are likely to be dangerous.”
Senior News Editor
By Isabella Cueto
By Helen Branswell
By Rachel Cohrs
By Mario Aguilar
By Megan Molteni
Reporting from the frontiers of health and medicine
Biotech & Pharma