MONDAY, March 18, 2002 (HealthDayNews) -- In November 2001, the U.S. Food and Drug Administration (FDA) issued a health warning about a popular diet supplement known as LipoKinetix.
Now, a group of California researchers say they have proof the FDA was on target in telling consumers to stay away from the supplement.
In a report released today online ahead of its April 16 publication in Annals of Internal Medicine, doctors from Cedars-Sinai Medical Center in Los Angeles detail seven cases of liver disease linked to LipoKinetix, including one woman who needed a liver transplant.
"All seven of these people were young and healthy when they started taking LipoKinetix. They had no medical history, no liver problems; they were not taking any other prescription or over-the-counter drugs, and they took the LipoKinetix according to the manufacturer's instructions," says Dr. Joya T. Favreau, lead author and an internist at Cedars-Sinai.
Two of the seven patients were identified via the FDA's Medwatch program, a self-reporting system that tracks individual reactions to drugs and supplements. The remaining five were all treated at Cedars- Sinai, where Favreau consulted on the cases.
"All of the patients suffered varying degrees of hepatotoxicity [liver damage], including one young woman who suffered so much damage she needed a liver transplant to survive," Favreau says.
For weight-loss expert Dr. Lou Aronne, the findings come as no surprise.
"This is what happens when you sell what amounts to medications, and not have to be accountable to anyone, in terms of regulating agencies," says Aronne, an endocrinologist at Weill Cornell Medical Center in New York City. With no system in place requiring proof of either a supplement's safety or effectiveness, it's too easy for questionable products to get into consumers' hands, he says.
LipoKinetix is a combination supplement containing norephedrine hydrochloride, caffeine, yohimbine hydrochloride, a drug that mimics thyroid action called 3,5, diiodothyronine and a compound known as sodium usniate.
Manufactured by Syntrax, of Cape Girardeau, Mo., it was sold as a way to "mimic exercise," the researchers say. Essentially, it was said to burn fat by causing muscles to burn calories more efficiently.
Although medical literature doesn't list any specific links between the individual ingredients in LipoKinetix and liver toxicity, doctors point to sodium usniate as the potential troublemaker.
"We know very little about this substance -- so we don't know if it's causing problems on its own or because it is combined with these other ingredients," Favreau says.
Aronne also believes it may be the sodium usniate: "I would look towards sodium usniate. I think it hasn't been studied enough, and it should be before it's included in other products again."
The seven patients who developed liver disease ranged in age from 20 to 32. Four were women, three were men, five were Japanese and two were white. The patients used the products anywhere from 10 to 84 days, and all suffered symptoms of liver disease within four weeks of taking LipoKinetix.
The five Japanese patients bought the products in different lot numbers from various local California health food stores, while the two white males in the study purchased it from the Internet. All sought medical help for stomach pains, and some also had nausea and vomiting. At least half of the patients developed jaundice, a yellowing of the skin caused by liver malfunction, and three required hospitalization. One needed a liver transplant.
Fortunately, Favreau says, all recovered after discontinuing LipoKinetix, but liver function tests did not return to normal for some four months.
"Clearly, not everyone who takes LipoKinetix is going to suffer liver problems. However, until we know what it is about this product specifically that caused the problems in these seven patients, we just don't know how many are at risk," Favreau says.
She's also concerned about people who may still be using this product, or one with similar ingredients.
While a trip to the manufacturer's Web site shows LipoKinetix and a similar product, AdipoKinetix, have been withdrawn from the market and are said to be no longer available for sale, Favreau fears there may still be stock on store shelves and on the Internet. Then, she adds, there are products with similar side effects still being sold.
It seems her fears are not unfounded.
At least one Web site currently advertises a product similar to LipoKinetix, using this pitch: "The FDA has determined that due to this product's effectiveness, "Adipo" will soon be
Gone Forever! Stock Up NOW!!!"
What To Do
If you have taken LipoKinetix or a similar product and have experienced symptoms of liver disease, including abdominal pain, nausea, vomiting, low-grade fever or jaundice, contact the FDA's Medwatch program at 888-463-6332 [888-INFO-FDA]. To obtain the report form online, click here.
To learn more about liver disease, visit The American Liver Foundation.
