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Posts Tagged ‘supplement’

FDA Warns Consumers about TimeOut

by admin on: November 2nd, 2011

TimeOut is a product that is marketed as a dietary supplement for sexual enhancement. These capsules are available in doses of 2500 mg/capsule. TimeOut has been distributed by websites that describe the product as 100% natural. Because these dietary supplements come with labels that resemble labels from legitimate products, and because the websites saythat they are made from ???100% natural??? ingredients, people may mistakenly believe that TimeOut, and otherproducts like it, are harmless. The U.S. Food and Drug Administration (FDA) thinks differently.

In a press release on Wednesday August 25, 2010, the FDA revealed that it had conducted tests, which determined that TimeOut capsules contain a drug that may result in dangerous decreases in blood pressure. The drug found in TimeOut is called hydroxythiohomosildenafil. This drug is similar to the drug sildenafil, which is the active pharmacological agent found in the drug commonly known as Viagra. Viagra is a prescription drug that is used to treat patients with erectile dysfunction. Like Viagra, TimeOut may interact with prescription drugs (nitrates) and lower blood pressure. The immediate risk for people taking this product is that they may be unaware of the potential for an adverse drug reaction, or for the low blood pressure, which may result in dizziness or light headedness.

While the FDA has not received any reports of adverse events, after thorough review, the FDA has recommended that people currently taking TimeOutstop taking this product. As Michael Levy (the Director of the FDA???s Division of New Drugs and Labeling Compliance) has stated, the FDA has noted a trend in that several products that have become available as dietary supplements for sexual enhancement over the past few years have contained active or adulterated ingredients or variations of these active ingredients.