Supplements containing female libido booster Addyi recalled – Stat – STAT

F

ollowing 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 womenssex 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. Its the first time federal officials have recalled a product contaminated with the drug.

Its 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.

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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.

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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 Amazonthrough February.

Andwhilesupplement 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 supporthealth or, in this case, promotesexual desire.

Theres 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 andargued 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, theres going to be no stopping this, he said.

What is actually in erectile dysfunction supplements?

The amount of undeclared flibanserin in a supplement could vary widely from one pill to the next, as has been the case with Viagra. Its also possible the drugcould be introduced into a supplement along with other potentially libido-boosting compounds, exacerbating thoseeffects.

We dont know what danger this poses because these combinations have never been studied before theyre 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 dont work, or they might work but are likely to be dangerous.

Megan Thielking can be reached at megan.thielking@statnews.com Follow Megan on Twitter @meggophone

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Supplements containing female libido booster Addyi recalled - Stat - STAT