Weight Loss – Products – Sibutramine

Posted by admin on 17th July 2009

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recalled weight loss product

recalled weight loss product


 

Slimbionic (and others) Recalled

The Food and Drug Administration (FDA) reports today that it has informed Young You Corporation that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient.  FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine (see below), an FDA-approved drug used as an appetite suppressant for weight loss.

The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown.  All lots of the following dietary supplement products are being recalled:

Brand Size Active Pharmaceutical Ingredient
Slimbionic 30 Capsules/Box Sibutramine
One Weight Loss Pill 30 capsules 30 Capsules/Bottle Sibutramine
SlimDemand Capsules 30 Capsules/Box Sibutramine
Botanical Weight Loss 30 Capsules/Box Sibutramine

The products listed above were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana, California.

FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Note that no illnesses or injuries have been reported to the company to date in connection with this product.

Young You Corp. has taken this voluntary recall action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Young You Corp. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

GENERIC NAME: sibutramine

BRAND NAME: Meridia

DRUG CLASS AND MECHANISM: Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. Released neurotransmitters may attach to other nerves or they may be taken up again by the nerves that release them, a process termed reuptake. Sibutramine blocks the reuptake of the neurotransmitters dopamine, norepinephrine, and serotonin. Blocking the reuptake of neurotransmitters alters the balance of neurotransmitters within the nerve cells and thereby affect nerve function and interaction.

Patients taking sibutramine may achieve a 5-10% reduction from their baseline weight. Additionally, sibutramine-assisted weight loss has been accompanied by improvement in blood lipids (e.g., cholesterol). Sibutramine was approved by the FDA in 1997.




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