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FDA News From a Drug Lawyer: Discard Certain Zicam Cold Remedies; Intranasal Zinc Product Linked to Loss of Sense of Smell
FDA warning about loss of sense of smell after use of Zicam cold product. Discuss your situation with a Zicam lawyer.
[Issued June 16, 2009] The U.S. Food and Drug Administration (FDA) today advised consumers to stop using three Zicam products marketed as over-the-counter cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
The products are:
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.
If you or a loved one has used Zicam products and are experiencing the loss of smell or taste, our lawyers may be able to help. Complete the form on this page for a free review of your potential case. A Weitz & Luxenberg representative will contact you as soon as possible.
see also:
2009 Recall
FDA Recall Order Zicam | Weitz & LuxenbergFDA orders recall of Zicam cold remedy nasal products, says law firm
Background
Zicam Lawsuit Background Information | Weitz & LuxenbergZicam Lawsuit Research Center info from Zicam Lawyers / Attorneys
FDA News
Zicam FDA News Information | Weitz & LuxenbergZicam Lawsuit: Discuss your loss of smell with a leading drug lawyer
