Posted March 29, 2013

Prescription Drugs Found In Prostate and Sexual Enhancement Supplements

October 24, 2012 the FDA issued a warning letter to USA Far Ocean Group Inc./ Health & Beauty Group Inc. because a number of the company’s dietary supplements were found to contain pharmaceutical drugs, or were promoted with statements that constitute drug claims.

U-Prosta was found to contain undeclared terazosin, the active pharmaceutical ingredient in an FDA-approved drug for benign prostatic hyperplasia. It was promoted with statements such as “To stop the hyperplasia of the prostate,” and “To prevent the occurrence and development of the prostate cancer.”

Terazosin can cause excessive lowering of blood pressure and loss of consciousness after initial doses, rapid increases in dose, or with concomitant administration of another blood pressure lowering medication.

Male Enhancer was found to contain tadalafil, an FDA-approved active pharmaceutical ingredient in the prescription erectile dysfunction drug Cialis. It was promoted with statements such as “Help to maintain healthy sperm production, motility,” and “Promote systemic and hormonal balance in male reproductive system.”

X-Hero was found to contain sulfosildenafil, a chemical analogue of the FDA-approved active pharmaceutical ingredient sildenafil, found in the prescription erectile dysfunction drug Viagra. It was promoted with statements such as “Natural plant Viagra” and “can improve the function of the kidney of the man.”

Tadalafil, sildenafil and sildenafil analogues can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerin, resulting in dangerously low blood pressure.

U-Prosta, Male Enhancer and X-Hero were also found to be misbranded because their product labels fail to declare the presence of these drugs and lack adequate warnings for the protection of consumers.

In addition, the FDA warned that statements made about the company’s New Prosta, New Hero, New Prosta 2nd Generation, Liver Care, Power Up, Cardio Care, Glucose Balance, Cholesto Care, and Quick Slim dietary supplements were found to drug claims.

These statements include “Cholesto Care ... extensively reduces coronary heart disease, myocardial infarction, stroke incidence, morbidity and mortality,” and “Glucose Balance' ... can effectively reduce blood sugar ... help people with diabetes ..”

See ConsumerLab.com’s Reviews of Cholesterol-Lowering Supplements, Sexual Enhancer Supplements, Prostate Supplements and Weight Loss Supplements for tests of related products.

See Related Warnings:

Recall: Male Sexual Enhancement Supplement Found to Contain Prescription Drug

Sexual Enhancement Supplements Recalled Due To Undeclared Drugs

Sexual Enhancement Supplements For Men and Women Recalled Due to Prescription Drug Risk

Sexual Enhancement Supplements Containing Prescription Drug Recalled

For more about the FDA’s warning letter, use the link below.