FDA warns against intake of men’s supplements found to contain anti-ED drugs

The Food and Drug Administration (FDA) on Monday warned the public against the intake of men’s food supplements manufactured in specific batches that were discovered to contain prescription drugs for erectile dysfunction.

According to a report on GMA's 24 Oras, a sample from the Bravo Male Supplement with lot number NU1Y617 and expiration date March 26, 2019 was positive of Tadalafil, a prescription drug for erectile dysfunction and impotence among men.

On the other hand, MS Male Tablet Herbal Dietary Supplement with manufacturing date February 20, 2017 and expiration date February 19, 2021 was also found to have Nortadalafil--an analogue compound of Tadalafil.

The presence of Tadalafil and Nortadalafil in the aforementioned male supplements violates the FDA Act of 2009 and Food Safety Act of 2013.

According to the FDA, incorporating this drug as an ingredient of food and dietary supplements may pose dangerous effects to health.

Side effects of Tadalafil include:

• headaches
• 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
• dizziness

Risks are higher for those who have already suffered from stroke, severe vision loss, stomach ulcers, heart diseases, kidney problems, liver diseases, bleeding problems, blood cell problems, and those who have low blood and high blood pressures.

FDA advised those who have taken the specified male supplements to consult a doctor it these symptoms persist.

Meanwhile, the Philippine Urological Association said that intake of Tadalafil and other similar drugs may only be advised if prescribed by a doctor.

For its part, Kauffman Pharma--the manufacturer of Bravo Male Supplement--said that they do not use Tadalafil in their products.

The company is now coordinating with the FDA.

Those who have purchased Bravo Male Supplement and MS Male Tablet Herbal Dietary Supplement with the respective manufacturing date/lot number were also advised by the FDA to coordinate with them at telephone number 857-1900 local 8105 or email foodsafety@fda.gov.ph. —Dona Magsino/NB, GMA News