FDA Issues Warning on Sex Product 53109

WASHINGTONFDA issued a consumer warning regarding Time Out Capsules, after FDA testing found the product, marketed as a dietary supplement, contained an undeclared pharmaceutical. Testing found the capsules contained hydroxythiohomosildenafil, a chemical similar to sildenafil, an FDA approved drug used to treat erectile dysfunction. The presence of the drug compound makes the product an unapproved new drug; hydroxythiohomosildenafil is also not listed on the product label. The drug can adversely interact with other pharmaceuticals, causing dangerous drops in blood pressure.

FDA noted it is not aware of any adverse events associated with use of the product; however, it urged consumers to stop using Time Out Capsules immediately. Adverse reactions or quality problems associated with use of the product can be reported via FDAs MedWatch Adverse Event Reporting System.

Timeout Products, based in Brooklyn, NY, offers a number of dietary supplements for different health conditions, including the Time Out Capsules formulated with a variety of botanical ingredients.