Diet Supplement Causes Liver Damage
Read Labels Closely for Toxic Ingredients
By Jeanie Davis
March 18, 2002 -- If you're taking a weight loss or bodybuilding supplement, listen up. Seven people in California have been treated for liver damage -- one of whom had severe liver failure -- that developed within one month after they started taking the weight loss supplement LipoKinetix.
Toxic reactions have been reported with several ingredients in LipoKinetix -- sodium usniate, yohimbine, and phenylpropanolamine (PPA). In fact, animals that have ingested lichens containing usnic acid -- a component of sodium usniate -- have become paralyzed and died.
While the FDA has forced removal of LipoKinetix from the market, products with similar ingredients are still available on the Internet.
Although no single liver toxin has been identified in LipoKinetix, the interaction of ingredients is likely causing the toxicity, says researcher Joya T. Favreau, MD, researcher at Cedars-Sinai Medical Center in Los Angeles. Her report appears in the April 16 issue of Annals of Internal Medicine.
In November 2001, the FDA issued a warning about the product, advising the distributor to take "prompt action" to remove LipoKinetix from the market.
However, the ingredients of LipoKinetix appear in other supplements marketed by the manufacturer. They also appear in products sold on bodybuilding and nutritional supplement Internet sites.
The seven patients in Favreau's report -- all otherwise healthy people between ages 20 and 32 -- were treated at Cedars-Sinai Medical Center in Los Angeles and were identified through the FDA's MedWatch program. Medwatch is the FDA's main source of reports about toxic reactions to supplements.
All had been taking LipoKinetix according to the manufacturer's recommendations. Five had been taking the supplement for one month or less. All had symptoms of acute liver damage, including fatigue and abdominal pain, and all had jaundice. All recovered spontaneously after they stopped taking LipoKinetix.
One patient developed severe liver failure with subsequent swelling in the brain. He was placed on a liver transplantation list but recovered on his own after the supplement was stopped.
"Dietary supplement products are not subject to review by the FDA before marketing," writes Favreau. The public and the medical community often are unaware when supplements contain ingredients in new combinations or dosages that may be toxic. Also, patients often don't tell their doctors that they are taking supplements.
An accompanying editorial calls for changes in laws that would mandate FDA regulation and safety surveillance of supplements.
"We require proof that prescription drugs are sufficiently safe and effective before marketing," writes James. D. Lewis, MD, of the University of Pennsylvania. "We require proof that over-the-counter drugs are extremely well studied, effective, and very safe before we permit them on the market for consumer use. Yet, there are no data for most supplements, merely because they do not claim to prevent or treat specific medical conditions."