The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.
FDA lab tests reveal that the product contains excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke, and heart attack.
Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects.
Sibutramine is a powerful stimulant that should not be used without a prescription due to the safety risks associated with it.
Slimming Beauty is being sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty. Slimming Beauty sample packets also have been distributed by individuals at community events. The product and the sample packets are falsely labeled as “100% Herbal.” The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.
The FDA has determined that Slimming Beauty sample packets were distributed at the 40th Annual Mexican Independence Day Parade in Chicago, on Sept. 12, 2010. The agency is aware of several reports of serious side effects from the use of this product including elevated blood pressure, headaches, vomiting, and insomnia.
Consumers and health care professionals are encouraged to report adverse events related to the use of Slimming Beauty capsules to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm or by phone at 800-FDA-1088 (800-332-1088).
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Showing posts with label sibutramine. Show all posts
Showing posts with label sibutramine. Show all posts
Friday, October 08, 2010
Tuesday, January 27, 2009
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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"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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