Zicam FDA Warning
On June 16, 2009, the Food and Drug Administration issued the following press release concerning Zicam products:
Text of FDA press Release for June 16, 2009
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
Intranasal Zinc Product Linked to Loss of Sense of Smell
The U.S. Food and Drug Administration today 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.
"Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). "We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason."
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.
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.
"Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold," said Deborah M. Autor, director of CDER’s Office of Compliance.
Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
In addition to the press release, the FDA also issued the following advisory concerning the use of Zicam products:
Text of FDA press Release for June 16, 2009
Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc
June 16, 2009
FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids 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). These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. However, these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.
This advisory does not concern oral zinc tablets and lozenges taken by mouth.
FDA recommends that consumers stop using these products and throw them away. See the FDA website for How to Dispose of Unused Medicines.
For treating symptoms of the common cold, consumers can take a number of other over-the-counter drugs. However, the common cold goes away without treatment, usually within seven to ten days.
Since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, FDA has received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. The reports vary. Many people state that the loss of sense of smell occurred with the first dose of the Zicam product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.
Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food. 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.
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.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Speak to a Lawyer
If you or a loved one has used Zicam Cold Remedy and has been diagnosed with anosmia, suffered the loss of smell or suffered the loss of taste, contact our law firm at once. It may be too late to recover from the debilitating effects of Zicam Cold Remedy, but an experienced product liability attorney can assist you in a legal action against the makers of Zicam. You are not alone. Join other anosmia victims in speaking up and fighting for their legal rights.
Please fill out our free legal evaluation form on the far right and we will call or e-mail you back within 24 hours. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.
