Do Not Use! LIPOKINETIX - A Liver Toxic Dietary Supplement Weight Loss Drug

Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) and a majority of the U.S. Congress are once again responsible for needless drug-induced injuries as a direct result of their dangerous, pro-quackery Dietary Supplement Health and Education Act (DSHEA) of 1994. This time it is liver toxicity from the dietary supplement drug LIPOKINETIX, hyped on the Internet as “chemical exercise in a bottle.” DSHEA allows potent plant drugs to be classified as foods (dietary supplements) and for all practical purpose has stripped away the Food and Drug Administration’s (FDA) authority to keep dangerous products such as LIPOKINETIX off the market.

LIPOKINETIX is a drug. We will no longer give the deceptive herbal and dietary supplement industry a free ride by calling these products simply “supplements.”

LIPOKINETIX is distributed by Syntrax Innovations, Inc. of Chaffee, Missouri and has been implicated in a number of cases of serious liver injury. The FDA has received reports of at least six people who developed acute hepatitis (inflammation of the liver) and liver failure or both while taking the drug. The injuries reported to the FDA occurred in persons between 20 and 32 years of age. No other cause for liver disease was identified in these cases. In all instances, no preexisting medical condition that would predispose these individuals to liver injury was identified. The onset of liver injury was seen between two weeks and three months after starting LIPOKINETIX.

We have previously warned about another Syntrax Innovations product, TRIAX, containing a breakdown product of natural thyroid hormone known as tiratricol (see the January 2000 issue of Worst Pills, Best Pills News). The FDA issued a warning to consumers about this drug in November 2000 because of cases of abnormal thyroid function in people taking TRIAX. This drug is about 1/20th as potent by weight as natural thyroid hormone. However, even this additional amount of thyroid hormone can cause serious health consequences including heart attacks and strokes.

LIPOKINETIX is a concoction of five drugs of doubtful or no therapeutic value in reducing the morbidity and mortality associated with obesity and lack of exercise: 1) nor-ephedrine (also known as phenylpropanolamine or PPA); 2) caffeine; 3) yohimbine; 4) diiodothyronine; and 5) sodium usniate. Each of the drugs is discussed below.

Phenylpropanolamine (PPA)
This drug has been used for years in prescription and non-prescription nasal decongestants and in non-prescription diet pills. The Health Research Group petitioned the FDA on October 19, 2000 to ban PPA from all non-prescription drug products (see the December 2000 issue of Worst Pills, Best Pills News). The FDA has now taken the necessary legal steps to formally ban PPA from the market.

There is abundant evidence in well over 100 published reports about the dangers of PPA and 51 reports of hemorrhagic stroke in PPA users in the FDA’s adverse drug reaction database. In addition, an industry-funded study conducted by researchers from Yale University found that “PPA increases the risk for hemorrhagic stroke.”

Caffeine
Caffeine is familiar to almost everyone. This drug stimulates the central nervous system and in large enough doses increases heart rate. Excessive intake of products containing caffeine can result in heart rhythm disturbances. It is especially dangerous in combination with drugs such as PPA.

Diiodothyronine
This chemical is similar in structure to the thyroid replacement drug liothyronine (CYTOMEL) except that it has only two iodine atoms instead of liothyronine’s three. Some diiodothyronine is naturally formed in the breakdown of liothyronine in the body. Diiodothyronine has also been used in the production of thyroxine (SYNTHROID).

We could find no information on the use of diiodothyronine, nor how it rates in relative potency to natural thyroid hormone. However, it could have some thyroid hormone activity and may present the same problems as TRIAX that was mentioned above.

Yohimbine
Yohimbe (Pausinystalia yohimbe) is a tree bark containing a variety of pharmacologically active chemicals that includes yohimbine. It is marketed in a number of products for body building and “enhanced male performance.” Serious adverse effects, including renal failure, seizures and death, have been reported to the FDA with products containing yohimbe.

Yohimbine is also a prescription drug in the United States. The adverse effects of this drug are well recognized and may include central nervous system stimulation that causes anxiety attacks. At high doses, yohimbine is a monoamine oxidase (MAO) inhibitor. MAO inhibitors can cause serious adverse effects when taken at the same time as foods containing the amino acid tyramine (e.g., liver, cheeses, red wine) or with PPA. LIPOKINETIX is a combination product with its own built-in adverse drug interaction: PPA and yohimbine.

This drug should also be avoided by individuals with hypotension (low blood pressure), diabetes, and heart, liver or kidney disease. The symptoms of overdosage include weakness and nervous stimulation followed by paralysis, fatigue, stomach disorders, and ultimately death.

None of the above four drugs seems to be a likely candidate for causing the liver toxicity that has been associated with the use of LIPOKINETIX. However, the last of the five chemicals listed as being in LIPOKINETIX may be the culprit.

Sodium Usniate or Usnic Acid
This chemical has been isolated from lichen and may also be present in Kombucha, a symbiotic yeast-and-bacteria aggregate surrounded by a permeable membrane. Kombucha advocates tout it as a cure for cancer, to decrease blood pressure, increase vitality, increase T cell (immune cell) counts, fight acne, relieve arthritis pain, eliminate wrinkles, cleanse the gall bladder, alleviate constipation, and restore original color to gray hair.

Cases of liver toxicity associated with the use of Kombucha have been reported in the medical literature. The Centers for Disease Control and Prevention investigated two cases of unexplained illness, one fatal, that may have been associated with the consumption of Kombucha. In neither of these cases was liver toxicity reported.

The link between sodium usniate and liver toxicity seen in users of LIPOKINETIX remains to be verified. Another possibility, however, is a liver toxic chemical in LIPOKINETIX that is not listed on the label. This is certainly a possibility with unregulated dietary supplement drug producers such as Syntrax Innovations, Inc.

Normally, when new safety warnings are required on a regulated drug product, the FDA can require a company to issue a “Dear Health Care Professional” letter. However, in the case of LIPOKINETIX the FDA sent the letter to health care professionals. In addition to informing practitioners about the risk of the drug, the letter asked that cases of liver toxicity be reviewed by practitioners to determine if any might be related to the use of dietary supplement drugs.

The FDA also sent a timidly worded letter to Syntrax Innovations, Inc. informing the company of the agency’s concerns about LIPOKINETIX. This letter exemplifies the FDA’s lack of authority to remove dangerous supplement drugs from the market. The FDA pleads with the company “... we strongly recommend that you take prompt action to remove LipoKinetix from the market.” And further begs “... you to alert your customers to immediately stop using LipoKinetix.”

It is appalling that after so many people were injured or killed in the late 19th and early 20th centuries from unregulated snake oil products that Senators Hatch and Harkin, with the passage of DSHEA, have sentenced the American public to relive that nightmare.

What You Can Do

You should avoid LIPOKINETIX and other dietary supplement drugs. These products possess no known health benefits and may carry unacceptable risks.