FDA Links Zicam to Anosmia
June 16, 2009
Two and a half years after a lawsuit against the manufacturers of Zicam and Cold-EEZE nasal gels was settled in January 2006 in which the companies made no admission that their products had caused anosmia (loss of the sense of smell) in 340 plaintiffs, the FDA has determined that intranasal application of zinc gluconate, the products’ active ingredient, is in fact the likely culprit.
The FDA announced today (June 16, 2009), following over 130 additional complaints from consumers who claim to have lost their sense of smell, that it is recommending that people stop using all intranasal products made by Zicam that include zinc gluconate. Intranasal zinc has been known to devastate olfactory nerves in humans and other animals for years but, because zinc products fall under the homeopathic provision of FDA laws, these products were not required to get FDA approval before going on the market.
The FDA recommends that anyone who has any of these products stop using them immediately, and have sent a letter to Matrixx Initiatives stating that the company cannot market these products without approval and that they do not contain adequate warnings about the risk of the loss of one’s sense of smell.
Cold-EEZE discontinued its cold remedy nasal spray product in 2004 and is now only available as a lozenge and as an orally-dissolvable tablet, and is thus not affected by the FDA decision regarding intranasal sprays. The products which are included in this warning are:
Zicam Cold Remedy Nasal Gel (15ml)
Zicam Cold Remedy Nasal Swabs (20 count)
Zicam Cold Remedy Swabs, Kids Size (20 count)
The FDA believes these products are harmful and could potentially cause permanent loss of the sense of smell. They are especially concerned about this problem in children because it may be more difficult for them to effectively tell someone that the problem has occurred. While less debilitating than lost eyesight or hearing, loss of the sense of smell carries potentially serious health and safety implications–olfactory clues warn us to avoid spoiled foods, to shut off the gas, to get out of that burning building–and are essential to our enjoyment of food.
If you believe your sense of smell was affected by using Zicam, you should contact your healthcare professional. You or your healthcare professional should then contact the FDA either online or by calling 1-800-FDA-1088.