The U. S. Food and Drug Administration (FDA) has warned Confidence Inc. of Port Washington, NY, manufacturer of METABOSLIM Apple Cider Vinegar brand dietary supplement about the presence of the undeclared drug ingredient, sibutramine, in their product.
FDA notified the company that FDA lab analysis of METABOSLIM samples found that the product contains undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. Since FDA has not approved Metaboslim as a drug in cannot contain sibutramine as an ingredient. The FDA has not evaluated the safety and effectiveness of Metaboslim as a drug.
Sibutramine, marketed as Meridia in the USA and Reductil in Europe and other countries, is usually administered, orally, for the treatment of obesity. In the US, sibutramine is classified as a controlled substance since it is related to the drug family of amphetamines. Abbott Laboratories manufacture Sibutramine
According to the FDA, the agency is posting this WARNING 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. Thus, sibutramine poses a substantial risk for the health and well being of unaware consumers. However, no illnesses or injuries have been reported to the company to date in connection with this product.
The product being recalled was sold in plastic bottles with white and red labeling and contained 60 gelatin capsules. Confidence, Inc has initiated a voluntary recall of its products after the FDA notified the company of the lab results regarding the presence of an unapproved drug in its product.
Sibutramine was approved by the U.S. Food and Drug Administration (FDA) in November 1997for the treatment of obesity. Sibutramine acts by increasing the patient’s levels serotonin and norepinephrine levels in the brain, known appetite and mood modifiers.
Sibutramine side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain. Also some infrequent side effects are: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).
Confidence, Inc. has undertaken this voluntary recall and is working with the FDA in the recall process. Jim Chao at 516-767-1870, firstname.lastname@example.org (Confidence, Inc. USA) can be contacted for further instructions for returning the product or with any questions regarding this health issue.
Confidence Inc. Issues a Voluntary Nationwide Recall in the United States and Canada of One Lot of METABOSLIM Apple Cider Vinegar brand dietary supplement found to contain an Undeclared Drug Ingredient. FDA press release. URL: http://www.fda.gov/oc/po/firmrecalls/confidence08_07.html
U.S. Food and Drug Administration (November 24, 1997). FDA APPROVES SIBUTRAMINE TO TREAT OBESITY. URL: http://www.fda.gov/bbs/topics/ANSWERS/ANS00835.html