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Earlier this summer the FDA stated that it had received 130 reports of anosmia, or loss of sense of smell, in users of three Zicam nasal cold remedies and warned consumers not to the products. The FDA alert lead to the recall of two of the products, Zicam Cold Remedy Swabs and Zicam Remedy Nasal Gel, by the makers of the product named Matrixx.
Matrixx had already withdrawn the third product named by the FDA, Zicam Cold Remedy Swabs for Kids. After the FDA issued the recall they learned of 800 more reports of Zicam problems that they were never notified of and they then issued a warning letter to Matrixx for withholding the information. The warning letter also stated that the product could not be marketed without agency approval and that the nasal remedies did not include proper warnings about the risk of anosmia.
When first introduced, Zicam was never approved by the FDA because it was classified as a homeopathic product. Once the products health concerns were identified however, the FDA forced the company to have the product approved.
The company has been named in multiple class action lawsuits since the Zicam recall by people who blame the products for their loss of smell and also faces a lawsuit filed by investor for losses that stem from the recall. Matrixx Initiatives reported a, bigger than expected, first quarter loss of $22.8 million ($2.49 per share). The company blames the Zicam issue for the poor results.
The gel swabs and nasal sprays have something called zinc gluconate in them, which can damage the nerves in the nose. However Matrixx Initiatives insist that Zicam does not deposit zinc deep enough to cause smell problems, that there was nothing wrong with the original formula and they no plans to reformulate the homeopathic product. They refuse that Zicam caused smell loss as reported by hundred of users and will continue to try to convince the FDA to allow them to bring back the products as they were.
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