FDA bans Grakcu capsules after discovery of controlled substances
Official warns that consuming these contaminated capsules can lead to serious health risks and may even prove fatal to some
The Food and Drug Administration (FDA) on Wednesday banned the sale of Grakcu herbal capsules used to treat erectile dysfunction after it found that the capsules contained two controlled drugs.
Dr Withit Sarideechaikul, FDA’s deputy secretary-general, said the lot with licence No G481/53 manufactured on May 2, 2024, and expiring on May 2, 2026, was found to contain Sildenafil and Tadalafil.
Withit said both these drugs were controlled substances used to treat erectile dysfunction.
He added that these drugs require a doctor’s prescription, as they are dangerous and can have severe side effects on people with liver, kidney, heart or blood pressure-related diseases.
Withit said these drugs are prescribed to enlarge arteries and can prove to be dangerous for some patients. Hence, he said, the FDA has ordered the distributor of the herbal capsules to remove the lot from shelves immediately.
The manufacturer has been advertising the capsules as a herbal concoction made following a Chinese recipe to help men with erectile dysfunction issues regain strength.
However, the FDA licence granted for the pills does not state that they contain Sildenafil and Tadalafil.
Withit warned that consuming these contaminated herbal capsules can cause side effects like headache, blurred vision, low blood pressure, myocardial infarction, high pressure in pupils, and hearing loss. It can even be fatal for some patients.
Withit said the manufacturer has been ordered to find out why this lot was contaminated with the two controlled substances and report its findings to the FDA as soon as possible.
