FDA Warning on Zicam - Linked to Loss of Smell

On June 16, 2009, the FDA warned consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kid Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia).

FDA notified consumers and healthcare providers to discontinue use of the Zicam products sold over-the-counter as cold remedies because the are associated with the loss of sense of smell. FDA recommends that consumers stop using these products and throw them away. Because Zicam Cold Remedies are homeopathic treatments, the FDA is limited in its capacity to regulate it, making a forced Zicam recall unlikely. In lieu of a Zicam recall, the three Zicam Nasal Cold Remedies have been discontinued.

The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam Products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or other signs of danger in the environment. Also, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating. The loss of the sense of smell can adversely affect a person's quality of life.

FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.