FDA takes hard line on erectile dysfunction supplement
Sulfoaildenafil is similar to sildenafil and is commonly used in Viagra, but is not authorized for use in dietary supplements, and so the FDA is warning consumers off the “herbal” and “all natural” capsules.
“Consumers who have Man Up Now capsules should stop using them immediately,” FDA said in its warning letter. “…this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply that can lead to dizziness or lightheadedness.”
The FDA said Man Up Now was being sold on internet websites, online marketplaces and in some retail outlets in blister packs and bottles, but no adverse events had been reported.
“However, sexual enhancement products that claim to work as well as prescription products, but that contain prescription strength drugs, are likely to expose unknowing consumers to unpredictable risks and the potential for injury or death,” the agency observed.
The issue has become so serious FDA commissioner, Margaret Hamburg, MD, issued a letter Wednesday to industry calling on it to remember its regulatory responsibilities and remain vigilant against potential transgressors.
Within it, Michael Levy, the director of the Division of New Drugs and Labeling Compliance at the FDA's Center for Drug Evaluation and Research said: "The labeling of these tainted products may claim that they are 'alternatives' to FDA-approved drugs, or 'legal' alternatives to anabolic steroids. Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”
The letter also upped the ante on punative measure the FDA may take against those found to be spiking products.
“Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.”
Canada
Health Canada also issued an alert for a product manufactured outside North America but which it was concerned may find their way onto Canadian shores, and which had been received warnings in its country of manufacture.
The range of sexual enhancement products called Shaguar, Signature Signergy (pictured), VIGRX (green capsule), VIGRX (white capsule), VigRx, and VigRX Plus had received warnings from New Zealand’s MedSafe.
They were found to be spiked with sildenafil, hydroxyhomosildenafil, thiosildenafil, and/or tadalafil.
Bodybuilding products called ArimaDex and Clomedwere also recalled by the FDA for containing aromatase inhibitor, a prescription drug.
The FDA also recently recalled a weight loss product called Slimming Beauty Bitter Orange Slimming Capsule, for contamination with sibutramine.
