Loosing the sense of smell, Zicam in review.
Zinc-containing cold remedy Zicam linked to loss of the sense of smell.

It can be shocking to realize that you have lost your sense of smell or taste, or even both at the same time. It can be even more paralyzing to find the side effect derived from a seasonal cold remedy. This is exactly what many people experienced in result of using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs for kids.

Since 1999, the Food and Drug Administration received over 130 reports associated with Zicam usage. Reports disclosed many people who experienced a loss of smell with the first dose, as well as others who reported a loss of the sense of smell after multiple uses of the product.

Accordingly to the FDA Zicam contains zinc, an ingredient scientists say can damage nerves in the nose. Inevitably the severed nerves in the nose can lead to temporary or permanent anosmia, a condition where the patient loses his or her sense of smell.

“’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 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.’” (FDA)

How does a product which can so severely affect a person’s quality of life make it to the market, without being rejected by the FDA? Zicam Cold Remedy is part of a small group of remedies that are not required to undergo federal review before release. This group is better known as homeopathic products, the formulation often contain herbs, minerals and flowers – which are not usually formally inspected by the FDA.

In a letter to Matrixx , The Food and Drug Administration asked to discontinue marketing their zinc-based product and submit safety and effectiveness data on the drug. Nevertheless, the product has not been recalled and remains on the market.

If you or your loved one experienced anosmia (damage to olfactory nerve, loss of the sense of smell) as a result of using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs or Zicam Cold Remedy Nasal Swabs for kids, contact us for a free consultation.

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.

Warnings on Three Zicam Intranasal Zinc Products
Zicam Linked to Loss of Sense of Smell

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.