The National Agency for Food and Drug Administration and Control, NAFDAC, says it has been notified on the recall of five brands of male sex enhancement pills sold on Amazon.
The public alert with No. 010/2022, signed by the agency’s Director-General, Prof. Moji Adeyeye, on Monday, stated that the recall was as a result of undeclared Tadalafil/Sildenafil present in the pills.
In view of this, NAFDAC is notifying the public of voluntary recall of the brands of the male sex-enhancement pills by their manufacturing companies.
The agency said it acted on a notification sent by Amazon to the Food and Drug Agency in the US, concerning the laboratory analysis which found the products to contain undeclared tadalafil/sildenafil.
According to the NAFDAC, sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitor found in the FDA approved product for the treatment of erectile dysfunction.
It 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 dietary supplements for male sexual enhancement and sold online on Amazon at http://www.amazon.com.
According to the alert, the undeclared tadalafil/sildenafil ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, capable of lowering blood pressure to dangerous levels that may be life-threatening.
It added that such situation is a risk for people with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.
While urging consumers to discontinue purchase and use of the implicated products, it added that members of the public in possession were implored to handover said products to the nearest NAFDAC office.
The agency also called on patients to contact their physicians or healthcare providers if they experienced any problems that might be associated with the usage of the implicated products.
“NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of the products to the nearest NAFDAC office, or NAFDAC PRASCOR (20543 TOLLS FREE from all networks).
It also called on the public to report any adverse effects via email@example.com; or through E-reporting platforms available on the NAFDAC website or via the Med-Safety application available for download on Android and IOS stores.