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LipoKinetix, Liver problems
NEW YORK (Reuters Health) - A supplement touted for weight loss appears to have caused severe liver toxicity in seven healthy people who developed symptoms within 3 months of starting the product, US researchers reported Monday.
Last November, the US Food and Drug Administration (news - web sites) (FDA) warned consumers to stop using the supplement, called LipoKinetix, after receiving reports of liver injury and liver failure among people using the product. The agency also told the supplement's manufacturer--Syntrax, of Cape Girardeau, Missouri--to take it off the market.
In the new report, researchers from the FDA and Cedars-Sinai Medical Center in Los Angeles,
California, describe seven patients who developed liver inflammation between July and December 2000--including one who developed liver failure.
All of the patients recovered spontaneously after stopping LipoKinetix, and none was taking
prescription or over-the-counter drugs, according to Dr. Joya T. Favreau and colleagues.
Their report was released Monday on the Web site of the Annals of Internal Medicine
(www.annals.org), ahead of its April 16 publication in the journal's print edition.
Five of the patients came to Cedars-Sinai with symptoms of acute hepatitis, such as abdominal pain and fatigue. The researchers describe one case in detail, a 20-year-old woman who developed symptoms such as fever, abdominal pain and jaundice--a yellowing of the skin. Tests revealed breakdown in the liver tissue. The patient had been taking LipoKinetix for 2 weeks when she sought medical care.
The two other cases had been reported to the FDA's MedWatch program. These two patients were bodybuilders who sought medical attention 9 to 12 weeks after starting LipoKinetix.
According to the researchers, it is unclear how the supplement could be toxic to the liver, as none of the individual substances in the product are known to have such effects. They speculate that an interaction between the various ingredients could be to blame.
LipoKinetix contains norephedrine, a stimulant found in some diet aids (news - web sites) that has been linked to such serious effects as heart attack and stroke. Other ingredients include caffeine and yohimbine--a product derived from tree bark that has been linked to nausea, vomiting, abdominal pain and other symptoms, Favreau's team reports.
These seven cases highlight the larger issue of whether it is time to put tighter regulations on the dietary supplement industry, according to an editorial accompanying the report.
NEW YORK (Reuters Health) - A supplement touted for weight loss appears to have caused severe liver toxicity in seven healthy people who developed symptoms within 3 months of starting the product, US researchers reported Monday.
Last November, the US Food and Drug Administration (news - web sites) (FDA) warned consumers to stop using the supplement, called LipoKinetix, after receiving reports of liver injury and liver failure among people using the product. The agency also told the supplement's manufacturer--Syntrax, of Cape Girardeau, Missouri--to take it off the market.
In the new report, researchers from the FDA and Cedars-Sinai Medical Center in Los Angeles,
California, describe seven patients who developed liver inflammation between July and December 2000--including one who developed liver failure.
All of the patients recovered spontaneously after stopping LipoKinetix, and none was taking
prescription or over-the-counter drugs, according to Dr. Joya T. Favreau and colleagues.
Their report was released Monday on the Web site of the Annals of Internal Medicine
(www.annals.org), ahead of its April 16 publication in the journal's print edition.
Five of the patients came to Cedars-Sinai with symptoms of acute hepatitis, such as abdominal pain and fatigue. The researchers describe one case in detail, a 20-year-old woman who developed symptoms such as fever, abdominal pain and jaundice--a yellowing of the skin. Tests revealed breakdown in the liver tissue. The patient had been taking LipoKinetix for 2 weeks when she sought medical care.
The two other cases had been reported to the FDA's MedWatch program. These two patients were bodybuilders who sought medical attention 9 to 12 weeks after starting LipoKinetix.
According to the researchers, it is unclear how the supplement could be toxic to the liver, as none of the individual substances in the product are known to have such effects. They speculate that an interaction between the various ingredients could be to blame.
LipoKinetix contains norephedrine, a stimulant found in some diet aids (news - web sites) that has been linked to such serious effects as heart attack and stroke. Other ingredients include caffeine and yohimbine--a product derived from tree bark that has been linked to nausea, vomiting, abdominal pain and other symptoms, Favreau's team reports.
These seven cases highlight the larger issue of whether it is time to put tighter regulations on the dietary supplement industry, according to an editorial accompanying the report.
