Personal Injury and Wrongful Death

Zicam Anosmia Lawsuits and Updated FDA Information

OUR MINNESOTA PERSONAL INJURY LAW FIRM IS NO LONGER TAKING THESE CASES.

PLEASE DO NOT CONTACT A PERSONAL INJURY LAWYER MN AT OUR FIRM ABOUT THE ZICAM RECALL.

FDA Udate on Zicam and Anosmia

The following is from an FDA Postmarket Review:

On June 16, 2009, FDA alerted healthcare professionals and consumers that Zicam Cold Remedy Nasal Gel (Zincum Gluconicum), Zicam Cold Remedy Nasal Swabs (Zincum Gluconicum), and Zicam Cold Remedy Swabs, Kids Size (Zincum Gluconicum) have been associated with long lasting or permanent anosmia (loss of the sense of smell). These products were available without a prescription, marketed as homeopathic remedies, and contained zinc gluconate as their active ingredient. The products were widely marketed for use in adults and children to reduce the duration and the 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. These products were widely marketed. Two-thirds of all Zicam intranasal products sold are the zinc-containing cold remedy products.1This safety information does not concern oral zinc tablets and lozenges taken by mouth.

In recent years, there is a growing body of evidence from nonclinical, clinical, and adverse event report data supporting a causal association between anosmia and zinc-containing nasal cold remedies. On June 16, 2009, FDA issued a warning letter to stop marketing Zicam intranasal zinc gluconate products.

From initial marketing of Zicam products in 1999 to June 18, 2008, FDA’s Adverse Event Reporting System (AERS) received 131 reports of individuals who developed anosmia associated with the use of intranasal zinc-containing Zicam products. All of the reports were from the United States. The reports indicate that Zicam was used for the prevention of the common cold and to treat cold symptoms, usually for a relatively short period of time (median duration of use was 3 days). The individuals ranged from 23 to 82 years old with a median age of 48 years. The most frequently reported additional symptoms included burning and pain in the nose, as well as headaches.

In most cases (127 of the 131 reports), anosmia following the use of Zicam intranasal products was persistent and still ongoing at the time the report was submitted (see Table 1).

Table 1. Duration of anosmia associated with the use of intranasal zinc-containting Zicam products in AERS reports.*

Total number of reports	131
Ansomnia at time of report	127 (97%)
Number of reports where ansomnia lasted > 6 months	38
Range	2 days - 4 years
Mean duration	7 months
Median duration	3 months

*Duration of anosmia was determined by the difference in time between the date of onset of anosmia and the date FDA received the report, unless the AERS report indicated a specific duration in the case narrative.

The abrupt onset of the anosmia, clinical presentation (severe burning or pain), and persistent (unresolved at time of report) loss of smell are inconsistent with post-viral anosmia and support an association between the intranasal Zicam products and developing anosmia. The onset and duration of anosmia in these reports are also consistent with cases of anosmia associated with the use of Zicam reported in the medical literature.2,3

Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, andZicam Cold Remedy Swabs, Kids Size were marketed without review and approval through FDA’s new drug application (NDA) process. Based on the cumulative data discussed briefly in this article, FDA warned the manufacturer to stop marketing zinc intranasal products without FDA approval. Through the NDA process, the manufacturer must provide information to demonstrate that the products are safe and effective.

Healthcare professionals are encouraged to remind consumers that:

They should stop using these products and throw them away.
They should contact their healthcare professional if they experience loss of smell or taste, or experience other problems after using any zinc-containing nasal products.
There are a number of other over-the-counter drugs for treating symptoms of the common cold that they can take. However, the common cold goes away without treatment, usually within 7 to 10 days.
They should report serious adverse events or product quality problems associated with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/safety/medwatch/default.htm.

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