Your thinking of DNP and cataracs.
No, I am not.
Dear Health Care Professional Colleague:
We are alerting you about a dietary supplement product that we believe presents a serious public health risk. LipoKinetix, distributed by Syntrax Innovations, Inc., has been implicated in several cases of serious liver injury. The Food and Drug Administration (FDA) has received reports of at least six persons who developed acute hepatitis and/or liver failure while using LipoKinetix. The injuries reported to FDA occurred in persons between 20 and 32 years of age. No other cause for liver disease was identified. In all cases, no preexisting medical condition that would predispose the consumer to liver injury was identified. Onset of liver injury was observed between 2 weeks and 3 months of starting LipoKinetix.
LipoKinetix has been promoted for weight loss by 'mimicking exercise' and supporting 'an increased metabolic rate'. The product contains norephedrine (also known as phenylpropanolamine or PPA), caffeine, yohimbine, diiodothyronine, and sodium usniate.
FDA has issued a consumer warning advising consumers to stop using this product and to consult their physician if they are experiencing symptoms possibly associated with this product, particularly nausea, weakness or fatigue, fever, abdominal pain, or any change in skin color.
We urge you to review your cases of hepatitis in order to determine if any may be related to the use of dietary supplements in these patients. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA's MedWatch program by telephone (1-800-332-1088) or internet (
http://www.fda.gov/medwatch).
Thank you for your efforts and cooperation in addressing this potentially serious public health issue. For additional information, see
http://www.cfsan.fda.gov.
Sincerely yours,
Christine Lewis Taylor, Ph.D.
Director
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
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Diet Supplement Caused Liver Damage To Seven Californians
March 19, 2002
(American College of Physicians-American Society of Internal Medicine) -- A dietary supplement marketed for weight loss, LipoKinetix®, apparently caused severe liver damage to seven people in Southern California.
Three of the seven, who were all young (between ages 20 and 32) and healthy, were hospitalized; one was placed on the waiting list for a liver transplant. The liver damage developed between two weeks and three months of beginning to use LipoKinetix®. Liver function returned to normal about three months after the patients stopped taking the supplement. Four patients bought the supplement in health food stores, and two bought it from body-builder Internet sites.
In November 2001, the Food and Drug Administration (FDA) issued a consumer and health professional warning about the product and told the supplement's distributor to take "prompt action" to remove LipoKinetix® from the market. The distributor does not currently list the product on its Internet site. The ingredients in LipoKinetix® appear in other supplements marketed by the manufacturer and in other products sold on bodybuilding and nutritional supplement Internet sites.
An accompanying editorial points out the need for regulation of dietary supplements, assurances of product safety, and ongoing monitoring and enforcement of safety standards.
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So there were six or seven depending on which report is correct, and at least one was a man, true.