Loss of sense of smell has been a recognized complication of intranasal Zinc application. Yesterday, the FDA finally came out with a warning regarding Zicam, a product which contains Zinc for intranasal application. I’ve reposted yesterday’s bulletin from the AAAAI to its members after the jump.
To me, this case illustrates a couple of important issues. First, you don’t get pharmaceutical effects without the potential for adverse reactions. Just because something is “natural” does not make it innately safer than compounds which are crated in a lab and extensively tested. Second, the lack of oversight of the supplement industry is appalling. As long as manufacturers call their product a dietary supplement and say “this product is not intended to diagnose, treat, or cure any disease” then they can say whatever they want without a shred of proof that their claims are true. If their products really work, they should be required to show proof of effectiveness and safety, just like the pharmaceutical industry.
“This morning, The Food and Drug Administration (FDA) held a news conference warning physicians and consumers about Zicam Cold Remedy intranasal products, indicating “these products may pose a serious risk to consumers who use them.” Specifically, the FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products. Some individuals also report loss of sense of taste.
Included in the warning are: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size. All are administered by direct application to the nasal cavity, and as described in the labeling, are intended for use in “adults and children 3 years of age and older (with adult supervision). These products are available without a prescription, and they contain zinc gluconate (identified as zincum gluconicum on their labels) as their active ingredient.
These OTC’s are marketed as homeopathic and therefore are not subject to FDA approval. However, given the risk, the FDA has issued a warning letter to Matrixx Initiatives, Inc, makers of the products. During the news teleconference, the FDA indicated they have asked Matrixx to work with the FDA in removal of the products from the market.”