Safety and Side Effects

COLD-FX^® HAS AN EXCELLENT SAFETY PROFILE

All relevant safety information for COLD-FX has been reviewed by the Canadian regulatory body prior to the issuance of a natural product license in February 2007. This process required the submission of all safety data from clinical trials, toxicology studies, interaction studies and previous marketing experience.

Safety Information:
Individuals requiring anti-coagulant therapy such as warfarin should avoid use of COLD-FX.
Do not use if pregnant or breastfeeding.
Not recommended for individuals with impaired liver or renal function.
Do not exceed the recommended daily dose.
Individuals with known allergies to ginseng should avoid use of COLD-FX.

High doses of some forms of ginseng which are high in ginsenosides have been shown to affect the metabolism and effect of blood thinners such as warfarin. COLD-FX is primarily composed of oligosaccharides and polysaccharides. Individuals taking anti-coagulant therapy such as warfarin should avoid the use of COLD-FX.

Most clinical trials with CVT-E002™ at two 200 mg capsules daily (COLD-FX) have been conducted in generally healthy adults, including seniors. There have been no published studies in children or pregnant women. COLD-FX is recommended for adults and children 12 years and older.

Laboratory studies demonstrate that COLD-FX does not affect major liver enzymes responsible for metabolism of drugs and herbs. Enzymes tested include: Cytochrome P450, Cytochrome b5, NADPH-cytochrome, P450 reductase, Monooxygenase, and Conjugation enzymes.

No adverse effects of COLD-FX are observed in laboratory studies when given at 500 times higher than the recommended dose at one time and 25 times higher than the recommended dose for 30 days. In clinical studies, COLD-FX has not been associated with an increase in adverse effects when compared to placebo. Although there are no known interactions with disease conditions, individuals with serious autoimmune disorders or serious medical conditions are advised to consult a health care practitioner before taking COLD-FX.

Quality Assurance:
As part of the quality control system and in accordance with the new regulations for natural health products, each lot of COLD-FX is subjected to a variety of chemical and immunological tests, in addition to other important quality parameters such as pesticide, microbial, and heavy metal content. Only lots meeting the tight specifications known to result in clinical safety and efficacy are released for sale.

References:
Ueng Y & Chen C. 2002. Effects of CVT-E002, a proprietary extract from North American ginseng (Panax Quinquefolium) on Drug-metabolizing Enzymes, Journal of Chinese Medicine. 13:89-96.

Holt, A. & Shan, J. 2005. Inhibition of human hepatic cytochrome P450 enzymes by COLD-FX and REMEMBER-FX^® - proprietary extracts of North American ginseng (Panax Quinquefolium). Journal of Complementary and Integrative Medicine. 2(1) (3):28.

To obtain references for clinical trials and other studies involving COLD-FX… click here