Zicam and Loss of Smell

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Modified on 2010/01/27 22:17 by LaurenKay
Zicam is marketed as an over-the-counter homeopathic cold remedy that reduces the severity and duration of common cold symptoms. The manufacturers of Zicam insist the medication cures the common cold three times faster than normal. Zicam is available in various forms, including a no-drip liquid nasal gel, chewable tablets and an oral mist. Matrixx Initiatives, Inc manufactures Zicam.

Several lawsuits have been filed against Matrixx, the developers and distributors of Zicam and the medication's contract manufacturer alleging Zicam nasal gel caused users to sustain permanent loss of sense of smell (anosmia) and taste. According to complaints, Zicam contains zinc gluconate, which has been linked to olfactory nerve damage when applied through the nose. Similar cases were reportedly submitted at a 2003 meeting of the American Rhinologic Society.

Those who have experienced a loss of sense of smell say the condition occurred with the first dose; while others reported a loss of smell after multiple uses. The agency is concerned that the loss of smell may be permanent and says published scientific literature provides evidence to support a link between intranasal zinc and anosmia.

Anosmia, can adversely affect a person’s safety by limiting their ability to detect the smell of gas, spoiled food or smoke and other dangers in the environment.

2006

Previous Matrixx Lawsuits

In 2006, Matrixx paid $12 million to settle numerous lawsuits brought by consumers who claimed to have lost their sense of smell. The company says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

2009

FDA Issues Public Health Advisory

On June 16, 2009 the FDA sent a Public Health Advisory to consumers urging them to stop use of Zicam Products because they are associated with the loss of sense of smell.

The three Zicam Products listed in the advisory are:

• Zicam Cold Remedy Nasal Gel (NDC 62750-003-10)

• Zicam Cold Remedy Swabs (NDC 62750-003-20)

• Zicam Cold Remedy Swabs, Kids Size (NDC 62750-003-21)

In response to the FDA warning letter, Matrixx released a statement which says, “The Company believes these products are safe and do not cause anosmia.”

FDA recommends that consumers stop using these products and throw them away. See the FDA website for How to Dispose of Unused Medicines. For more information on Zicam Products, refer to the Zicam Fact Sheet located on the FDA Web site.

The makers of Zicam have paid $12 million to settle over 300 lawsuits since 1999. Yet, the drug has never been officially recalled. In fact, after the latest FDA warning, the company refuses to recall the drug. However, before Zicam products can be marketed again, the company will have to gain FDA approval.

InjuryBoard Members Share Zicam Concerns

InjuryBoard Member, Joe Saunders says, "Hundreds of consumer lawsuits have already been filed as a result of Zicam's link to anosmia. And many more are expected as a result of the FDA action." He also notes, Matrixx officials stated in a press release they'll comply with the FDA directive but would like an opportunity to meet with FDA officials.

InjuryBoard Member, David Mittleman writes, “ Was Loss of Smell from Zicam Nasal Products Really a "Big Surprise?" During a routine investigation of Matrixx in May 2008, the FDA discovered the company had received 800 consumer complaints that users were losing their sense of smell associated with nasal gel and nasal swab products, which the company failed to report to the agency.

InjuryBoard Member, Jim Lewis, writes on his blog about a study by Dr. Burton Slotnick that found only a partial and/or temporary loss of smell in mice when given large doses and the damage was reversed within a couple weeks.

The problem, notes Lewis, is the study was largely supported by a grant from Matrixx. While he doesn’t accuse Dr. Slotnick of impropriety, he says it does make one question the outcome of a study on a product that’s being funded by the manufacturer of said product.

Reports by doctors not funded by Matrixx offer a different finding. Dr. Bruce Jafek, an otolaryngologist at University of Colorado Hospital reported about the loss of smell from Zicam nasal spray usage at a clinical meeting in 2003.

Dr. Jafek stated, "In my opnion, the product is dangerous in putting zinc ions into the nose ... If a person wishes to continue to use this product certainly they should be warned that they could lose their sense of smell. It's an uncommon problem but for the person who loses their sense of smell, it's devastating."

Several InjuryBoard Members have written about Zicam and loss of sense of smell.

Help For Consumers

Consumers who have experienced loss of sense of smell associated with the use of zinc-containing products administered into the nose should contact their health care professional, recommends the FDA.

Adverse events should also be reported by health care professionals and consumers to the FDA’s MedWatch program either online or by phone at 1-800-FDA-1088.



See Also

  1. Common Cold Drugs: Overview
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