TimeOut Capsules, marketed as a dietary supplement for sexual enhancement on the Internet, can dangerously lower blood pressure, warns the U.S. Food and Drug Administration (FDA).
Consumers may mistakenly assume the product is harmless and poses no health risk because it is labeled as “100% Natural.”
The agency advises people who have taken the recalled supplements to stop use immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to health risks and possibly even death in some cases.
To this date, the FDA has not received any reports of illness associated with this recall.
The FDA determined the recalled supplements contain hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like that chemical, hydroxythiohmosildenafil may negatively interact with other prescription drugs, including nitrates. The blood pressure drop can deprive the brain of a sufficient blood supply, leading to dizziness or lightheadedness.
Consumers should consult their medical doctor if they have experienced any adverse side effects associated with these products. Consumers are urged to report negative side events to the FDA’s MedWatch program at 800-FDA-1088.