FDA, ZICAM, and LOSS OF YOUR SENSE OF SMELL (ANOSMIA)

Matrixx Initiatives, Inc. has had to remove several varieties of Zicam nasal cold remedies from the market because of their association with anosmia (loss of the sense of smell).  Our lawyers have filed numerous personal injury lawsuits for people who lost their ability to smell, and in some cases taste, after using a Zicam nasal gel or swab to treat or prevent a cold ad we are investigating on behalf of many more. Zicam contains zinc gluconate which has long been associated with loss of smell (anosmia).

The FDA has received more than 130 reports of loss of sense of smell associated with the use of the above Zicam products. The loss of sense of smell associated with Zicam use may be long-lasting or permanent. In addition, individuals have reported losing sense of smell after using Zicam for the first time and after using multiple doses of the product.

Loss of the sense of smell can also affect the ability to taste. The loss or impairment of the senses of smell and taste, poses both quality of life (inability to taste foods or enjoy fragrances) and safety (inability to detect danger signals such as smoke, gas, or spoiled food) issues.

On June 16, 2009, the Food & Drug Administration (FDA) warned consumers not to use three Zicam products - Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size - because of reports of anosmia in some users. At the same time, the FDA issued a warning letter to Matrixx Initiatives stating that the three Zicam products named in the alert could not be marketed without agency approval. The warning letter also stated that the products did not include adequate warnings about the risk of anosmia.

According to the FDA, the following Zicam products should not be used:

• 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 FDA release stated "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." For more information visit the FDA.

Sadly, the victims of Zicam anosmia could have easily been spared their pain and suffering, as the association between Zicam nasal gels and swabs and the loss of smell and taste was well-known long before the FDA issued its alert. In fact, Matrixx Initiatives actually paid $12 million to settle a class action lawsuit in 2006 with hundreds of people who blamed Zicam for their inability to smell and taste. Yet even after the settlement, Matrixx Initiatives continued to market Zicam nasal swabs and gels as a safe remedy for the common cold.

Zicam is marketed as homeopathic. It's not required to stand up to the rigors of FDA approval. Because so-called homeopathic remedies do not require FDA approval, Matrixx Initiatives did not adequately test Zicam products for safety and effectiveness. Zicam products were sold over-the-counter as cold remedies although the products have not been shown to be effective in the reduction of the duration and severity of cold symptoms In addition to being extremely unsafe, there is little convincing evidence to support claims that Zicam prevents or significantly lessens the duration of a cold.

WHAT CAN YOU DO?

The FDA advises consumers to contact their health care professional if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products. The FDA also encourages consumers and professionals to report suspected Zicam side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting program, or by phone 800-FDA-1088.

If you were a victim of a defective Zicam nasal swab or gel, we urge you to contact a Zicam anosmia attorney at our firm right away to protect your legal rights (1-800-481-1615) or by email.