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Drug & Device News

By ALM Staff | Law Journal Newsletters |

FDA Warns Against Use of Zicam

The Food and Drug Administration has issued a warning to consumers advising them to stop using the popular over-the-counter cold remedy Zicam because its use has been associated with anosmia, the loss of the sense of smell. The warning covers adult and children's versions of Zicam nasal swabs, as well as Zicam nasal gel. The warning came after the FDA received more than 130 consumer complaints of loss of the sense of smell following Zicam use, sometimes after even one use. The product, which has not been approved by the FDA, has been marketed as a homeopathic remedy. However, FDA has now issued a warning letter to Zicam's manufacturer, Matrixx Initiatives, telling it that it should cease selling the product until such time as it receives FDA approval to market it to the public.

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