Pharmaceutical

Undeclared Viagra, Cialis in dietary supplements put users at risk for side effects

supplements 249x210 Undeclared Viagra, Cialis in dietary supplements put users at risk for side effectsUndeclared sildenafil and tadalfil, the active ingredients in the erectile dysfunction drugs Viagra and Cialis, respectively, were found in eight dietary supplements made by Nova Products, the Food and Drug Administration (FDA) reported.

The products are marketed as dietary supplements. Under federal law, supplements cannot contain active drug ingredients. The products must also declare any active ingredients. Not disclosing this information on the product’s label puts consumers at risk for adverse events, the agency said.

Sildenafil and tadalfil are prescription drug ingredients and have side effects and contraindications that can make the drugs dangerous to some individuals. Recent studies have found that men who used Viagra were at an increased risk of developing melanoma, the most deadly form of skin cancer. Other drugs in the class, such as Cialis, may also put men at increased risk of melanoma.

Nova products found to contain the drug ingredients include Xzone 1200, Mojo Risen, Black Ant, African Black Ant, Xzen 1200, Xzen Platinum, Xzen Gold, and Xzone Gold.

The agency sent the supplement maker a warning letter and followed up to make an inspection but were not allowed to conduct the review.

“Our investigator was refused required access to the complete inventory of all products previously sampled. The FDA regards this refusal as a serious violation because it hinders our investigators’ ability to thoroughly and completely evaluate your firm’s ability to market and distribute products that do not violate the FDCA (Federal Food, Drug, and Cosmetic Act),” the warning letter stated.

Since receiving the letter, Nova has removed the products from its website.

Sources:
FDA
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