Product marketed for sexual enhancement
is contaminated with potentially dangerous ingredient
August 25, 2010 - The U.S. Food and Drug
Administration is warning consumers not to take TimeOut Capsules because it
contains an active drug ingredient that can dangerously lower blood pressure.
The product is marketed as a dietary supplement for sexual enhancement.
TimeOut is labeled as “100% natural” and
consumers may mistakenly assume the product is harmless and poses no health
risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500
mg capsules.
Consumers who have TimeOut Capsules
should stop using them immediately. Sexual enhancement products that claim to
work as well as prescription products are likely to expose consumers to
unpredictable risks and the potential for injury or death.
The FDA analyzed TimeOut and determined
that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil,
the active ingredient in Viagra. Like sildenafil, this chemical may interact
with prescription drugs such as nitrates, including nitroglycerin, and cause
dangerously low blood pressure. When blood pressure drops suddenly, the brain is
deprived of an adequate blood supply which can lead to dizziness or
lightheadedness.
To date, the FDA is not aware of any
adverse events associated with the use of this product.
The FDA advises consumers who have
experienced any negative side effects from sexual enhancement products to
consult a health care professional and to safely discard the product. Consumers
and health care professionals should report adverse events to the FDA's MedWatch
program at 800-FDA-1088 or
online.
During the past several years, the FDA
has found many products marketed as dietary supplements for sexual enhancement
that can be harmful to consumers because they are adulterated with ingredients
in FDA-approved drugs or variations of these ingredients.
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