FDA Warns Consumers to Avoid TimeOut Capsules

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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FDA Cautions on Accurate Vitamin D Supplementation for Infants

The Food and Drug Administration today alerted parents and caregivers that some liquid Vitamin D supplement products are sold with droppers that could allow excessive dosing of Vitamin D to infants.

The FDA also advised manufacturers of liquid Vitamin D supplements that droppers accompanying these products should be clearly and accurately marked for 400 international units (IU). In addition, for products intended for infants, FDA recommends that the dropper hold no more than 400 IU.

The American Academy of Pediatrics (AAP) has recommended a dose of 400 IU of Vitamin D supplement per day to breast-fed and partially breast-fed infants. The easiest way to ensure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. The AAP’s recommendations are provided hereExit Disclaimer.

Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences such as kidney damage.

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FDA Warns Consumers to Avoid Vita Breath Dietary Supplement

The U.S. Food and Drug Administration is advising consumers not to purchase nor consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif., and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead.

The FDA was notified by the New York City Department of Health and Mental Hygiene about a patient with lead poisoning who reported taking Vita Breath and two other herbal products. The department analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.

The FDA has collected and is currently analyzing its own samples of Vita Breath.

People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing, and individuals who have taken Vita Breath should talk to their health care providers about testing.

The FDA is working with state officials in New York and California to further investigate Vita Breath.

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FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug

The U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks.

"Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "But when present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke."

Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research Industries Inc. (ALR Industries), Oak View, Calif. On Dec. 24, 2008, ALR Industries initiated a recall of all lots of Venom HYPERDRIVE 3.0 after the FDA laboratory analysis showed samples of the product contained undeclared sibutramine. Although ALR Industries claims on its Web site that only "trace amounts" of sibutramine were found in this product, the FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.

The product was sold via distributors and in retail stores nationwide as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France and the United Kingdom. The product was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.

Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Consumers can contact the company at legal@alrindustries.com to receive further instructions for returning the product and to ask any questions.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

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