The National Agency for Food and Drug Administration and Control has recalled five brands of male enhancement pills sold on Amazon.
The public alert number 010/2022, signed Monday by the agency’s chief executive, Professor Moji Adeyeye, said the recall was due to the undeclared presence of tadalafil/sildenafil in the pills.
In view of this, NAFDAC informs the public about the voluntary recall of male enhancement pills brands by their manufacturing companies.
The agency said it acted on a notification sent by Amazon to the Food and Drug Agency in the United States, regarding lab analysis that found the products contained undeclared tadalafil/sildenafil.
According to NAFDAC, sildenafil and tadalafil are ingredients known as a phosphodiesterase (PDE-5) inhibitor present in the FDA-approved product for the treatment of erectile dysfunction.
He further stated that the presence of sildenafil/tadalafil in the products made them unapproved drugs for which their safety and efficacy had not been established and therefore subject to recall.
These implicated products are marketed as male sexual enhancement dietary supplements and sold online on Amazon at www.amazon.com.
According to the alert, the undeclared ingredient tadalafil/sildenafil may interact with nitrates found in certain prescription medications, such as nitroglycerin, which can lower blood pressure to dangerous, potentially life-threatening levels.
He added that such a situation is a risk for people with diabetes, high blood pressure, high cholesterol or heart disease who often take nitrates.
While urging consumers to stop buying and using the offending products, he added that members of the public in possession were implored to turn over said products to the nearest NAFDAC office.
The agency also called on patients to contact their doctor or healthcare provider if they experience any issues that may be associated with the use of the implicated products.
“NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to product use to the nearest NAFDAC office, or NAFDAC PRASCOR (20543 TOLLS FREE from all networks).
He also called on the public to report any adverse reactions via [email protected]; either via the E-reporting platforms available on the NAFDAC website or via the Med-Safety application available for download on the Android and IOS stores.