OTC erectile dysfunction supplement recalled
After Food and Drug Administration (FDA) testing revealed the presence of the non-authorised constituent in one batch of Stamina Rx, Hi-Tech voluntarily instigated a recall of all batches.
It advised consumers to stop using the supplement and published a number to call for those who may have suffered an adverse event. Consumers were also advised to contact the FDA Medway web site.
Benzamidenafil is not listed on Stamina-Rx’s ingredients list and is similar to active ingredients in erectile dysfunction drugs like Viagra, Cialis, and Levitra.
"Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels,” said Hi-Tech in a statement.
“Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.”
Stamina-Rx contains two proprietary ingredients: Xanthoparmelia Scabrosa and Cnidium Monnier as well as yohimbe extract, L-Arginine, Gamma Amino Butyric Acid (GABA) and epimedium (Horny Goat Weed).
Product marketing said Stamina-Rx could,“Increases the sex drive as effectively as any compound known to science!”
Stamina Rx and Stamina Rx for Women previously drew regulator attention when in 2003, it was found to contain the prescription drug ingredient, tadalafil, the active constituent in Cialis, Eli Lilly’s erectile dysfunction drug that was at time approved in Europe but no the US.
