Supplements Pulled for Undeclared Sibutramine
FDA tests prompted recall by marketer of 'natural' weight-loss supplements.
Feb. 5, 2010— -- The marketer of three "natural" dietary weight-loss supplements issued a voluntary recall of the products after FDA tests confirmed the pills contained the undeclared weight-loss drug sibutramine.
The recall affects a number of Fruta Planta products sold in Columbia and Venezuela and marketed by the U.S. company Godi International, including Fruta Planta in 30-capsule boxes, Reduce Weight Fruta Planta in 30-capsule boxes with a gold sticker and Reduce Weight Fruta Planta in 30-capsule boxes.
The FDA testing revealed that a sample of the weight-loss supplements contained 18 mg of sibutramine. Godi added in a statement that all formulations of the supplement contain the drug and that none of the Fruta Planta products are safe for use.
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Patients should discard any remaining product away from children or animals, the statement said.
Sibutramine was pulled from U.S. markets in October 2010 due to increased risk of stroke and myocardial infarction, and may increase blood pressure and pulse rate in some patients. The drug also may "present a significant risk" for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke, and may cause potentially fatal interactions with some drugs, according to the company.
Similar Fruta Planta products were recalled by PRock Marketing in January following a number of adverse events.
No adverse events were reported related to use of Godi International's Fruta Planta, the statement said.
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