In recent times, multiple companies have recalled male sexual enhancement supplements that are sold online because they were found to be tainted with prescription erectile dysfunction (ED) drugs.
The U.S. Food and Drug Administration said the recalls were issued because the supplements contained undeclared pharmaceutical agents. The products were tainted with drugs that were not listed as ingredients, meaning people who take them do not know what drugs are they ingesting, which could lead to other health issues including or adverse drug reactions.
The FDA said, “Products with undeclared drug ingredients violate federal law.”
In December, the agency enlisted more than 50 OTC male sexual enchantment products sold online on Amazon, eBay, and other websites, issuing a warning to consumers. It said the products “have been found to contain hidden ingredients and may pose a significant health risk.”
At the time, the agency said, “The FDA purchased these products on Amazon and eBay and agency testing found that the products contain active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking.”
In the male sexual enhancement product category, the undeclared drugs were sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra), which are prescription-only ED drugs.
Sildenafil, tadalafil, and vardenafil are FDA- approved impotence drugs, which should be used under the supervision of a doctor.
The FDA said those drugs are called “phosphodiesterase (PDE-5) inhibitors” that “may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.”
Dr. Donald Ashley of the FDA said, “Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant and communicate about products and companies that place U.S. consumers at risk.”
“While the FDA has engaged in discussions with online marketplaces like Amazon and eBay regarding these issues in the past,” he added, “we believe they can do more to protect consumers from these fraudulent and potentially dangerous products.”
Some of the recent recalls include products such as:
- PremierZEN Extreme 3000, PremierZEN Plus 5000 and Triple SupremeZEN Plus 3500
- Imperial Gold 2000, PremierZEN Extreme 3000, Burro en Primava 60000, Imperial Platinum 2000
- PremierZen Platinum 5000 and Triple SupremeZen Gold 3500
- Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69
- Thumbs Up 7 Blue 69K and Thumbs Up 7 Red 70K
- Imperial Extreme 2000 mg capsules
- Yin-Yang Essence Men Power
- Zing Plus
- 2 Own The Knight Silver 4000
The abovementioned supplements were found to be tainted with sildenafil, tadalafil, or vardenafil. The FDA advises people to check with a doctor rather than self-medicating with supplements that are not approved or regulated.