FDA issues warning against 2 herbal dietary supplements for men
Published Nov 4, 2018 05:43 pm
By Analou de Vera
The Food and Drug Administration (FDA) has warned the public against the consumption of specific batches of two herbal dietary supplements for men which the agency deemed as "adulterated."
(MANILA BULLETIN)
In its advisory no. 2018-313, the agency advised the public to avoid purchasing and consuming specific batches of Ms for Male Tablet Herbal Dietary Supplement; and Bravo Maca + Jatropha + Corynaea Crassa Food Supplement for Men.
For the Ms for Male Tablet Herbal Dietary Supplement, the advisory covers those with manufacturing date of February 20, 2017 and expiry date of February 19, 2021.
For Bravo, the directive covers those with Lot Number NU1Y617 and expiry date of March 26, 2019.
The agency noted that the said products were found to contain Nortadalafil and Tadalafil based on its postmarketing surveillance.
Tadalafil is a prescription drug used to treat male sexual function problems, such as impotence or erectile dysfunction (ED); while Nortadalafil is an analog compound of tadalafil, the agency said.
“The presence of drug ingredients Tadalafil and Nortadalafil deems the food/dietary supplements as adulterated,” said the FDA.
“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.
The FDA advised that if one experiences any of the side effects upon consumption of the product, he should immediately consult a healthcare professional.
(MANILA BULLETIN)
In its advisory no. 2018-313, the agency advised the public to avoid purchasing and consuming specific batches of Ms for Male Tablet Herbal Dietary Supplement; and Bravo Maca + Jatropha + Corynaea Crassa Food Supplement for Men.
For the Ms for Male Tablet Herbal Dietary Supplement, the advisory covers those with manufacturing date of February 20, 2017 and expiry date of February 19, 2021.
For Bravo, the directive covers those with Lot Number NU1Y617 and expiry date of March 26, 2019.
The agency noted that the said products were found to contain Nortadalafil and Tadalafil based on its postmarketing surveillance.
Tadalafil is a prescription drug used to treat male sexual function problems, such as impotence or erectile dysfunction (ED); while Nortadalafil is an analog compound of tadalafil, the agency said.
“The presence of drug ingredients Tadalafil and Nortadalafil deems the food/dietary supplements as adulterated,” said the FDA.
“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.
The FDA advised that if one experiences any of the side effects upon consumption of the product, he should immediately consult a healthcare professional.