By Aderogba George
Abuja, The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned Nigerians on the use of Alpha male plus male enhancer fruit chews, due to undeclared content of the product.
The warning was contained in a public Alert No. 030/2021, which was made available to the News Agency of Nigeria (NAN) on Thursday, in Abuja.
The agency also warned Nigerians to be cautious against taking Alpha male plus dietary Supplement, as the US-FDA was recalling the product due to the presence of undeclared Tadalafil and Sildenafil in them.
NAFDAC stated in the alert that it had been informed by the U.S. Food and Drug Administration (US-FDA) that Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots of unexpired Alpha Male Plus male enhancer fruit chews.
The agency said that the recall had become necessary because the result of recent analysis by FDA found the product to contain undeclared tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved product for the treatment of male erectile dysfunction.
“The presence of tadalafil in Alpha male plus male enhancer renders the product an unapproved drug for which safety and efficacy have not been established.
“Alpha male plus male enhancer fruit chew is marketed as a dietary supplement for male sexual enhancement and sold online.
“The possible risk is that the undeclared tadalafil ingredient may interact with nitrates found in some prescription drugs, such as nitro-glycerine, and may lower blood pressure to dangerous levels that may be life threatening.
“People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“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,’’ the alert warned.
NAFDAC, therefore, implored consumers to stop the purchase and use of Alpha male plus, stressing that members of the public in possession of the product are advised to handover it to the nearest NAFDAC office.
The agency also called on patients to contact their physician or healthcare provider, if they have experienced any problems that may be related to using the implicated product.
NAFDAC also encouraged healthcare professionals, consumers and patients to report any noticed adverse effects related to the use of this product to the nearest NAFDAC office or contact NAFDAC PRASCOR (20543 TOLLS FREE from all networks).
It added that Nigerians could also report via pharmacovigilance@nafdac.gov.ng, e-reporting platforms available on the NAFDAC website or via the Med-safety application available for download on android and IOS stores. (NAN) (www.nannews.ng) Flowerbudnews
