FDA Advises Consumers to Stop Using Zicam; Active Ingredient Can Cause Loss of Smell

In a press release dated June 16, 2009, the U.S. Food and Drug Administration (FDA) advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued “kids size” swabs. The FDA’s advisory stated that the products are associated with the loss of sense of smell, called anosmia.

Anosmia may be long-lasting or permanent. In addition to a loss of the sense of smell, patients have also complained of a loss of the sense of taste. The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. Many people experienced a loss of smell said the condition with the first dose; others reported a loss of the sense of smell after multiple uses. The active ingredient in Zicam is Zincum Gluconicum (Zinc Gluconate) which can cause nasal nerve damage.

If you notice a burning sensation in the nasal cavity or a loss of smell or taste while using Zicam, stop using it immediately and contact a doctor. The loss of sense of smell can adversely affect a persons quality of life, and can limit the ability to detect the smell of gas or smoke 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.

Zicam is considered a “homeopathic remedy” rather than a drug. These types of products can be marketed without the government oversight required of “conventional” foods and drugs. Manufacturers are not required to register their products with FDA, nor must they receive the FDA’s approval before producing or selling these products. The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval. Matrixx said the FDA’s actions are “unwarranted” — but the company is reviewing its options, which may include removing these products from the market.

The lawyers at Levine & Slavit have decades of experience handling personal injury claims including those involving dangerous products. For 50 years spanning 3 generations, we have obtained results for satisfied clients. We have offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas. To learn more, watch our videos.

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