Syntrax LipoKinetix Liver AERs Necessitate Product Removal – FDA
This article was originally published in The Tan Sheet
Executive Summary
LipoKinetix should be withdrawn from the market due to reports linking the weight-loss supplement to "at least six" cases of serious liver injury, FDA states in a 1Nov. 19 letter to Chaufee, Mo.-based Syntrax Innovations
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LipoKinetix should be withdrawn from the market due to reports linking the weight-loss supplement to "at least six" cases of serious liver injury, FDA states in a 1 Nov. 19 letter to Chaufee, Mo.-based Syntrax Innovations. "Our evaluation of the complaints of serious injuries associated with the use of LipoKinetix shows that it is associated with acute hepatitis when used under the conditions of use recommended on the label," FDA says. As a result, the agency urges Syntrax to "alert your customers to immediately stop using" the product and to remove it from the market. FDA also issued a 2 'Talk Paper' Nov. 19 warning consumers not to use the product and sent a same-day 3 letter to healthcare professionals alerting them to the risk presented by LipoKinetix. The "Talk Paper" urges consumers to immediately discontinue use of the supplement and "consult their physician if they are experiencing symptoms possibly associated with this product, particularly nausea, weakness or fatigue, abdominal pain, or any change in skin color." Physicians are asked to review "cases of hepatitis in order to determine if any may be related to the use of dietary supplements in these patients." The agency notes both physicians and consumers should report "adverse events associated with the use of dietary supplements...as soon as possible to FDA's MedWatch program." The incidents of acute hepatitis and/or liver failure attributed to the supplement were reported in people between 20 and 32 years of age and "no apparent cause of liver injury was identified in these reports other than use of LipoKinetix," according to FDA. Liver injury developed within two weeks to three months after initial use. Sold in health food stores and gyms, LipoKinetix has been promoted as aiding in weight loss by "mimicking exercise" and supporting an "increased metabolic rate," the agency notes. The supplement's ingredients include caffeine, yohimbine, diiodothyrone, sodium usniate, and norephedrine (also known as phenylpropanolamine or PPA). Although the agency focused on the product's liver toxicity, it appears LipoKinetix also could have been subject to FDA action due to the presence of PPA, an ingredient once found in OTC cough/cold medications and weight-loss products. PPA was deemed not generally recognized as safe in OTC drugs last fall by FDA's Nonprescription Drugs Advisory Committee due to data connecting it to an increased risk of hemorrhagic stroke in women (4 (Also see "PPA AER Underreporting Probable, NDAC Says In Vote Against GRAS Status" - Pink Sheet, 23 Oct, 2000.), p. 4). Following the meeting, the agency requested that all PPA-containing OTCs be withdrawn from the market. However, despite the fact the ingredient may not be used in OTC drugs, FDA's Center for Food Safety & Applied Nutrition said it does not have a position on the presence of PPA in dietary supplements. Syntrax said it is still marketing another weight-loss supplement with PPA, AdipoKinetix , which has been on the market for four years. The company said the product differs from LipoKinetix in that it does not contain diiodothyrone and sodium usniate. The company also maintained LipoKinetix has not been sold since January 2000 due to a shortage of PPA, adding the product had been available for only one year prior to its withdrawal. In a written response to the agency's actions, the firm additionally contended that "FDA received their only complaints over one year ago from one doctor only during a very specific timeframe." The Nov. 19 "Talk Paper" is not the first FDA has issued with regard to a Syntrax dietary supplement. In November 1999, the Missouri Department of Health embargoed roughly 2,000 bottles of Triax Metabolic Accelerator (5 (Also see "Triax Weight Loss Supplement Distribution Halted At FDA's Request" - Pink Sheet, 15 Nov, 1999.), p. 4). The agency filed a civil forfeiture action seeking condemnation and destruction of the product because it contained what FDA described as "a potent thyroid hormone which may cause serious health consequences including heart attacks and strokes" (6 (Also see "Tiratricol-Containing Products Not Dietary Supplements - U.S. Judge" - Pink Sheet, 12 Mar, 2001.), p. 10). |