(RxWiki News) The supplement X-Rock has been voluntarily recalled by manufacturer XROCK Industries because it contains a related version of a drug approved by the U.S. Food and Drug Administration.
A release by the FDA recommends that anyone who has X-Rock capsules should stop using them immediately and let their doctor know if they have had any health problems occur while taking the product, the FDA stated.
Unused X-Rock can be returned for a full refund at the store where it was bought or to XROCK Industries directly.
"Stop using X-Rock supplements immediately."
X-Rock was found to contain the chemicals sildenafil and hydroxythiohomosildenafil, which has a chemical structure similar to sildenafil. Sildenafil is the active ingredient of Viagra, a drug approved by the FDA to treat erectile dysfunction.
Because the supplement contains sildenafil, it is likely to have similar effects on the body, including similar side effects. One counterindication - or conflict with other drugs - of sildenafil is taking nitrates at the same time.
If a man is taking nitrates and then takes a drug or supplement with sildenafil, it can dangerously decrease his blood pressure. Nitrates, which include the drug nitroglycerin, are a class of drugs often taken by people with diabetes, high blood pressure, high cholesterol or heart disease.
"Erectile dysfunction is a common problem in men with these conditions, and they may seek products to enhance sexual performance," the FDA release states. Therefore, a supplement containing sildenafil that could dangerously conflict with the nitrates a man may be taking poses a health risk.
In addition, hydroxythiohomosildenafil can cause additional side effects including headache or flushed skin.
The recall includes all UPC codes of X-Rock for Men, which is sold individually as one capsule on a blister card.
XROCK Industries has not received any reports of serious side effects or problems related to this recall, according to the FDA.
Consumers needing information to return the product can call 1-877-976-2563 Monday through Saturday 9am-9pm EST for instructions or visit the company's website.
Anyone who does experience an adverse event or medical problem they believe to be related to using X-Rock should report the occurrence to the FDA's MedWatch Adverse Event Reporting Program online or by mail or fax. The fax number is 1-800-FDA-0178.
This recall was announced by the FDA online April 19.