Zicam, the FDA, and Clinical Trials
This is my site Written by Alex on June 18, 2009 – 10:12 am   

The homeopathic nasal gel and swabs for cold relief symptoms, Zicam, has been slapped with an FDA warning that its use can cause people to lose their sense of smell. Shipment of the products have been halted by the manufacturer after 130 reports of people losing their sense of smell, perhaps some permanently. There has been no recall. Questions being asked in light of the FDA warning is: Why didn’t clinical trials reveal that Zicam has this side effect before the product was marketed? Did Zicam’s manufacturer, Matrixx Initiatives, Inc., know its product caused anosmia, the medical term for loss of the sense of smell? Here are a few clarifications on the issue of clinical trials and Zicam:

  • Zicam does not have FDA approval because it is a homeopathic remedy and not a “drug.” Like all such natural treatments including vitamins and other supplements, it is NOT REQUIRED to apply for or receive FDA approval for it to be marketed to the public.
  • Because it has not undergone clinical trials for FDA approval, Zicam has no proven clinical benefits.
  • In limited clinical trials., it has been shown that zinc, the active ingredient in Zicam, can shorten the severity and length of cold symptoms if treatment is received 24 hours after the onset of the cold.
  • There is some discussion – chiefly in an article in today’s New York Times – that when zinc was tested as a nasal treatment for polio prevention in the 1930s it was found to cause anosmia. This is false. Clinical trials in the 1930s studying┬ázinc sulfate – a different compound than the zinc gluconate in Zicam – revealed anecdotal evidence that some subjects suffered loss of smell.

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