Cold-fX

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Cold-FX
InventorAfexa Life Sciences Inc.
ManufacturerValeant Pharmaceuticals International
AvailableAvailable
Current supplierValeant Pharmaceuticals International
Websitewww.cold-fx.ca

Cold-FX is a product derived from the roots of North American ginseng (Panax quinquefolius). There is little evidence to support that Cold-fx is effective in the common cold.[1][2] All trials have been done by the manufacturer and there has been poor data reporting.[1]

According to Health Canada's Natural Health Product Directorate records, the company claims that it may "help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system".[3] It was formulated by Jacqueline Shan[4] and originally manufactured by her company, Afexa Life Sciences (formerly called CV Technologies),[5] which was acquired by Valeant Pharmaceuticals in 2011.

Medical uses

There is no evidence that Cold-fx is effective in those infected with the common cold.[6] The effect of preventative use is not clear.[6] When used preventively it makes no difference on the rate of infections.[2] It also appears to have no effect on how bad the infections are.[2] There is tentative evidence that it may lessen the length of sickness when used preventively.[2]

Side effects

Individuals requiring anti-coagulant therapy such as warfarin should avoid use of American ginseng. Not recommended for individuals with impaired liver or renal function. It is not recommended in those who are pregnant or breastfeeding. Other adverse effects include: headaches, anxiety, trouble sleeping and an upset stomach.[6]

Criticism

The product has not been shown to reduce the number or severity of common colds.[2] There is tentative evidence that it may shorten colds in people who are otherwise healthy adults when taken preventively.[2] All studies posing 'significant' results on its efficacy were funded by the manufacturer.[2]

Other criticisms point out that these studies have been small scale, with conspicuously shallow participant pools and lopsided gender distributions.[7] Researchers have pointed out that there aren't enough studies on the effects of any form of ginseng on the common cold to form any conclusions.[8]

Scientists have argued that the product has not been tested for its ability to treat a cold after an individual has been infected.[9] No studies have yet been performed to assess the possible long term side effects of taking the pills every day during the cold and flu season.[7] The manufacturer was criticized for making health claims about the product that have never been tested or scientifically verified. Until February 2007, the company advised a regimen of 18 pills over a course of 3 days in order to obtain "immediate relief" from a cold. Health Canada's review of the scientific literature confirmed that this is not a claim that it was entitled to make.[10] The company formulated a separate product for this usage. A CV Technologies press release explained the change in the dosing regimen as a choice to take a two-tier approach application to Health Canada.[11]

In 2015 a class action lawsuit was launched that claimed that the manufacturer misled people.[12] A B.C. Supreme Court judge refused to certify the class-action, but did not rule on the claim itself.[13] The appeal on this case has been dismissed.[14]

References

  1. 1.0 1.1 Nahas, R; Balla, A (Jan 2011). "Complementary and alternative medicine for prevention and treatment of the common cold". Canadian Family Physician. 57 (1): 31–6. PMC 3024156. PMID 21322286.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 Seida, JK; Durec, T; Kuhle, S (2011). "North American (Panax quinquefolius) and Asian Ginseng (Panax ginseng) Preparations for Prevention of the Common Cold in Healthy Adults: A Systematic Review". Evidence-Based Complementary and Alternative Medicine. 2011: 282151. doi:10.1093/ecam/nep068. PMC 3136130. PMID 19592479.
  3. "Product Information". Archived from the original on 2013-10-23.
  4. Keung, Nicholas (16 June 2014). "From Chinese village girl to Canadian CEO: Cold-FX founder writes her story". Toronto Star. Torstar. Archived from the original on 23 October 2014. Retrieved 17 June 2014.
  5. "What is COLD-fX intended for?". Cold-fX: Frequently Asked Questions. Archived from the original on 2007-11-27. Retrieved 2007-11-24.
  6. 6.0 6.1 6.2 Nahas, R; Balla, A (Jan 2011). "Complementary and alternative medicine for prevention and treatment of the common cold". Canadian Family Physician. 57 (1): 31–6. PMC 3024156. PMID 21322286.
  7. 7.0 7.1 "Fighting the Common Cold". ABC News. 2005-10-25. Archived from the original on 2022-01-22. Retrieved 2022-12-15.
  8. William Lin (2007-02-16). "Does ginseng really work? It depends on who you ask". The Ottawa Citizen. Archived from the original on 2008-06-21.
  9. "Ginseng Unproven in U.S." Los Angeles Times. 2008-02-18. Archived from the original on 2013-12-13.
  10. Charlie Gillis (2007-03-26). "COLD-fX catches the sniffles again". Maclean's Magazine. Archived from the original on 2012-02-07.
  11. "COLD-fX Sets Record Straight: Health Canada's Approval of New Medical Claims Unchanged" (PDF). CV Technologies. March 5, 2007. Archived from the original (PDF) on October 2, 2011.
  12. "Cold-FX users were misled about top-selling cold and flu remedy, lawsuit alleges". National Post. March 31, 2015. Archived from the original on 30 June 2023. Retrieved 23 June 2015.
  13. "Cold-FX class action lawsuit tossed - Toronto Star". thestar.com. 16 November 2016. Archived from the original on 3 July 2018. Retrieved 15 December 2022.
  14. "B.C. Appeal Court rejects class action lawsuit aimed at Cold-FX". financialpost.com May 2, 2018. Archived from the original on April 15, 2019. Retrieved December 15, 2022.

External links