The FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent.

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.

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional.

The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

What products are affected by this warning?

The FDA’s action affects Zicam’s three intranasal products that contain zinc. The three Zicam products claim to reduce the duration of the common cold and the severity of cold symptoms.

The products (listed with their size and product numbers) are:

• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

The Zicam intranasal zinc products are widely sold in pharmacies, other retail stores, and on the Internet. Zicam Cold Remedy Swabs, Kids Size, has already been discontinued, but the FDA is concerned that consumers may have the product in their home. The FDA has special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.

Why did the FDA take action?

The agency has received more than 130 reports of anosmia – the loss of sense of smell – associated with use of these three Zicam products.

Many people who experienced a loss of sense of smell say that the condition occurred with the first dose, although some people have reported loss of sense of smell after later doses. The FDA is concerned that the loss of sense of smell may be permanent.

What steps did the FDA take?

• The FDA issued a public health advisory warning consumers to stop using and discard or return the Zicam zinc-containing intranasal products
• The agency sent a warning letter to Matrixx Initiatives advising the firm that these products cannot be marketed without FDA approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell

What should consumers do if they experience harm related to these products?

The FDA recommends they contact their health care professional if they experience loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.

The agency asks health care professionals and consumers to report possible cases of loss of sense of smell or other problems after use of these products to the FDA through the MedWatch program, either online or by phone at 1-800-FDA-1088.

FDA 06/16/09