Slimming Beauty Capsules
FDA Issues Recall of Dietary Supplement Due to Presence of Potentially Dangerous Pharmaceutical Ingredient
On October 8, 2010, the U.S. Food and Drug Administration (FDA) announced a recall of a dietary supplement marketed under the brand name “Slimming Beauty Bitter Orange Slimming Capsules.” The over-the-counter supplements were found to contain Sibutramine, a prescription weight loss drug. Those using these supplements are at risk for serious cardiac problems, including the risk to suffer a heart attack or stroke.
Because of potential risks associated with the use of Sibutramine to treat obese patients, the drug is only available to those under a doctor’s care and the sale of the drug is restricted under the FDA’s Controlled Substances Act.
The FDA advisory follows.
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 the FDA website.
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