MANILA, Philippines — The Food and Drug Administration (FDA) is urging the public to stop 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 FDA Advisory No. 2019-518, the agency said it found tadalafil in a batch of Bravo Maca + Jatropha + Corynaea Crassa food supplement for men.
Use of tadalafil is “prohibited” in making food or dietary supplements, it said.
Health Undersecretary Eric Domingo, the acting FDA chief, said taking Bravo supplement from lot ABV38F26T, which expires on Feb. 26, 2021, could be harmful to health.
Tadalafil is a prescription drug used to treat male sexual function problems like impotence or erectile dysfunction. It is sold under the brand name Cialis.
There is also Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.
Health risks
“[I]t poses potential health risks to the unwary consuming public, especially those who have had a stroke, severe vision loss, persons experiencing stomach ulcers; heart, kidney, liver, bleeding and blood cell problems, and low or high blood pressure,” Domingo said.
Possible side effects are indigestion, back pain, muscle aches, stuffy or runny nose, flushing and headaches.
‘Adulterated’
Because of the presence of tadalafil in Bravo, Domingo said the questioned batch had been deemed “adulterated” and in violation of the Food Safety Act.“Consumers are advised to stop taking [the supplement], and consult a health care professional in case you experience any of the side effects upon consumption of the product,” he said.
Those who have bought the product are advised to immediately coordinate with the FDA at 857-1900 local 8105 or email cfrr@fda.gov.ph.
Continued sale or distribution of this supplement and other unregistered health products may be reported through email at report@fda.gov.ph.