The National Agency for Food and Drug Administration and Control (NAFDAC) says it has been notified about the recall of five brands of male s3x 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.
According to the alert, NAFDAC is notifying the public of a voluntary recall of the brands of the male sex enhancement pills by their manufacturing companies.
It stated that the recall followed a notification by Amazon to the Food and Drug Agency (FDA), U.S.A, of the laboratory analysis which found the products to contain undeclared tadalafil/sildenafil.
NAFDAC explained in the alert that Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction.
It 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.
The alert said that the implicated products are marketed as dietary supplements for male sexual enhancement and sold online on Amazon at www.amazon.com.
According to the alert, the undeclared tadalafil/sildenafil ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels that may be life-threatening.
NAFDAC explained in the alert that Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction.
It 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.
The alert said that the implicated products are marketed as dietary supplements for male sexual enhancement and sold online on Amazon at www.amazon.com.
According to the alert, the undeclared tadalafil/sildenafil ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels that may be life-threatening.
-threatening.
It added that such a situation is a risk for people with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.
The alert said that consumers with underlying medical issues who take Alpha male plus male enhancer with undeclared tadalafil may experience serious health risks as the PDE-5 inhibitors may interact with nitrates found in some of their prescription drugs.
NAFDAC, however, implored consumers to stop the purchase and use of the products.
It added that members of the public in possession of the implicated products were implored to stop the sale or use, as well as handover products to the nearest NAFDAC office.
NAFDAC also called on patients to contact their physicians or healthcare providers if they experienced any problems that may be related to using any 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 events via pharmacovigilance@nafdac.gov.ng, or through E-reporting platforms available on the NAFDAC website or via the Med-Safety application available for download on android and IOS stores. (NAN)
