| U.S. Food and Drug Administration |
FDA News Release, Nov 19, 2001
Letter to Health Care Professionals on Hazardous Dietary Supplement LipoKinetix.
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).
Thank you for your efforts and cooperation in addressing this potentially
serious public health issue.
Sincerely yours,
Christine Lewis Taylor, Ph.D.
Director
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This letter was prepared by the FDA Center for Food Safety and Applied Nutrition.