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Zicam
Matrixx Initiatives markets Zicam, an intranasal cold remedy product containing zinc. However, these products have not been shown to be effective in alleviating cold symptoms and may have a potential side effect - loss of smell (anosmia).
People with anosmia may not be able to smell smoke, a gas leak, or spoiled food. In addition, anosmia may be associated with a loss of sense of taste (ageusia).
It appears based on an FDA list of Zicam products that the following Zicam products - Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (discontinued product), may have a potential side effect and have all been associated with a long lasting or permanent loss of smell - anosmia.
FDA ACTION
On June 16, 2009, the FDA (after review of Zicam) issued a public health warning to consumers to stop using some of Matrixx Initiatives Zicam products.
In particular, the FDA warned consumer's to stop using (essentially a recall) and discard the following Zicam intranasal zinc products - Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10); Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20); and Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21) because of potential side effects and health concerns.
Apparently, the FDA has received and done a review of more than 130 side effect reports of anosmia - loss of smell - from people who have used the Zicam products. The reports vary, but people have reported a loss of smell after the first application and many have reported a loss of smell after multiple uses of the product.
The FDA is very concerned that consumers may unknowingly use a product that may have a side effect and cause them serious harm, e.g. loss of smell.
In addition, the FDA has released a video - "Intranasal Zinc May Cause Loss of Smell" - to help everyone, including healthcare personnel, better understand what is happening with Zicam.
In addition, the FDA has advised Matrixx Initiatives that these Zicam products cannot be marketed without FDA approval.
FDA ZICAM PRODUCT LIST NOT AFFECTED BY WARNING
According to the FDA list of Zicam products, the following Zicam brands are NOT affected by the warning:
- Zicam Cold Remedy RapidMelts with Vitamin C
- Zicam Cold Remedy Oral Mist
- Zicam Cold Remedy Chewables
- Zicam Cold Remedy ChewCaps
- Zicam Cold Sore Gel Swabs
- Zicam Multisymptom Cold and Flu Liquid-Daytime
- Zicam Multisymptom Cold and Flu Liquid-Nighttime
- Zicam Multisymptom Cold and Flu To Go-Daytime
- Zicam Multisymptom Cold and Flu To Go-Nighttime
- Zicam Cough Max Cough Spray
- Zicam Cough Max Cough Melts
- Zicam Extreme Congestion Relief Nasal Gel
- Zicam Intense Sinus Relief Nasal Gel
- Zicam Healthy Z-ssentials
- Zicam Seasonal Allergy Relief Nasal Gel
- Zicam Seasonal Allergy Relief Gel Swabs
- FDA list of Zicam products
Matrixx News Release
According to a Matrixx news release, the company is starting to send out notice letters to formally notify retailers, wholesalers and distributors of its recall of all Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs.
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