FDA: TimeOut May Pose Risk

WASHINGTON, Aug. 27 (UPI) — A dietary supplement marketed for sexual enhancement contains an active drug ingredient that may dangerously lower blood pressure, U.S. officials say.

Officials at the U.S. Food and Drug Administration say the dietary supplement TimeOut is labeled as “100 percent natural” and consumers may assume the product is harmless and poses no health risk but consumers should stop using them immediately.


The FDA analyzed TimeOut — which is purchased on the Internet — and found it contained hydroxythiohomosildenafil, a substance similar to sildenafil, the active ingredient in Viagra. The chemical, like sildenafil, may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure, FDA officials say.

If blood pressure drops suddenly, the inadequate blood supply to the brain can lead to dizziness or lightheadedness — but to date the FDA is not aware of any adverse events associated with the use of the product, a statement says.

The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a healthcare professional and to safely discard the product.

Consumers and healthcare professionals should report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

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