By Bohol Island News Staff | 08:09 PM December 19, 2019
The Food and Drug Administration (FDA) has warned the public of using a popular brand of men’s food supplement after a batch of it has been found to contain a substance used to treat erectile dysfunction, which poses health risks to men who have had heart problems.
In its advisory no. 2019-518, the agency advised the public to avoid purchasing and consuming specific batch of Bravo Maca + Jatropha + Corynaea Crassa Food Supplement for Men.
The directive covers those with Lot Number ABV38F26T, which expires on Feb. 26, 2021, could be harmful to health.
The agency noted that the said products were found to contain Nortadalafil and Tadalafil based on its postmarketing surveillance.
Use of tadalafil is “prohibited” in making food or dietary supplements, it said.
Tadalafil is a prescription drug used to treat male sexual function problems, such as impotence or erectile dysfunction (ED), the agency said.
“The said components are prohibited in food/dietary supplements, since these pose potential health risks to the unwary consuming public, especially those who have had a stroke, severe vision loss, persons experiencing stomach ulcers, heart problems, kidney problems, liver disease, bleeding problem, blood cell problems, and low or high blood pressure,” it added.
The FDA noted that the possible side effects if these products were consumed are headache, indigestion, stuffy or runny nose, flushing, sudden loss or decrease in hearing, difficulty of breathing sometimes with ringing in the ears, tingling in chest, arms, neck or jaw, numbness, back pain, muscle aches, changes in vision, and dizziness.
Because of the presence of tadalafil in Bravo, the questioned batch had been deemed “adulterated” and in violation of the Food Safety Act.”
Consumers are advised to stop taking the supplement.
Those who have bought the product are advised to immediately coordinate with the FDA at 857-1900 local 8105 or email firstname.lastname@example.org.
Continued sale or distribution of this supplement and other unregistered health products may be reported through email at email@example.com.