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FDA warns against intake of men's food supplement


The Food and Drug Administration has warned the public against the intake of a food supplement for men that was discovered to contain a prescription drug for erectile dysfunction.

According to Ivan Mayrina's Thursday report on "24 Oras," a batch from the BRAVO Maca + Jatropha + Corynaea Crassa Food Supplement for Men with lot number ABV38F26T was positive of Tadalafil, a prescription drug for erectile dysfunction, impotence among men and pulmonary hypertension.

FDA said a doctor's prescription is needed before Tadalafil can be taken.

FDA added that incorporating Tadalafil as an ingredient to food supplements is prohibited since it may pose dangerous side effects such as stroke, change in vision, ulcer and heart and kidney problems.

"'Yong prescription medicines kasi mayroon siyang indication and kontra indication, hindi katulad ng food na safe 'yan for general consumption. Ang gamot, mayroong mga tao na puwedeng mag-take at mayroong mga taong hindi puwedeng mag-take kaya nagagamit lamang ito o nabibili kung mayroong reseta ng doktor," FDA director general Eric Domingo said.

In November 2018, the FDA has already issued a similar advisory against the BRAVO Maca + Jatropha + Corynaea Crassa Food Supplement for Men due to the same reason.

Despite not having a recall notice, the company Kauffman Pharma, who makes the supplement, voluntarily withdrew the batch from the market.

Meanwhile, Kauffman Pharma still said there is no Tadalafil in their men's supplements and they are conducting their own study regarding the matter.

"Our conscience is very clear that Tadalafil is not present in our drug. Maybe what they're saying is similar to Tadalafil but it's not Tadalafil," Gil Caoile, product manager of Bravo Kauffman Pharma said.

On the other hand, the FDA said they will let the company explain regarding their discovery of Tadalafil in one batch of their product.

FDA added that if  proven that Kauffman Pharma violated its policies, the company may be charged and their product registration may be revoked. —Ma. Angelica Garcia/LDF, GMA News