Personal Injury and Wrongful Death

FDA Warning and FAQ

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ZICAM RECALL LAWSUIT UPDATE: Several lawsuits have been filed alleging Zicam caused loss of smell (anosmia) and taste, and our lawyers are reviewing potential claims. We are gathering information about Zicam smell loss.

Zicam: FDA Consumer Warning

On June 16, 2009, the U.S. Food and Drug Administration advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these 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.

According to FDA reports, Matrixx Initiatives received over 800 reports of smell loss (anosmia) before this warning was issued. Matrixx did not report these cases of smell loss to the FDA.

"Hundreds of people have lost their sense of smell because Matrixx Initiatives did not adequately test the Zicam Cold Remedy products and then failed to remove the product from the market after it received reports of smell loss," stated Attorney Elliot Olsen. "Smell loss is a serious injury that significantly affects a person's quality of life, especially because the sense of taste is also affected.”

Although Matrixx Initiatives did recall Zicam, it was too little too late. We invite people who have experienced smell loss after using Zicam products to contact our law firm for a free consultation.

Zicam: FDA Warning FAQ

On June 16, 2009, the Food and Drug Administration (FDA) warned consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell.

Intranasal products are administered through the nose.

What products are affected by this warning?
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 FDA is concerned that consumers may have the product in their home. 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.

Are oral zinc products affected by this warning?
No. This warning does not involve oral zinc tablets and lozenges taken by mouth.

Dietary zinc is also not subject to this warning. Zinc is an important trace mineral that is an essential part of the human diet. Among other things, Zinc is needed for a healthy immune system (the body's defense), and is critical for normal growth. Zinc primarily comes from food. The best way to get the daily requirement of essential vitamins and minerals is to eat a balanced diet that contains a variety of foods.

Why did 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. FDA is concerned that the loss of sense of smell may be permanent.

What steps did FDA take?
• 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?
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.

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