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On June 16, 2009, the FDA advised consumers to discontinue use of three nasally administered versions of Zicam Cold Remedy—Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (a discontinued product)—because the FDA had associated a serious risk of anosmia with them. [21]
Petitioner Matrixx Initiatives, Inc., is a pharmaceutical company that sells cold remedy products through its wholly owned subsidiary Zicam, LLC. One of Zicam's main products is Zicam Cold Remedy (Zicam), which is produced in the form of a nasal spray or gel containing the active ingredient zinc gluconate.
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Cold medicines are a group of medications taken individually or in combination as a treatment for the symptoms of the common cold and similar conditions of the upper respiratory tract. The term encompasses a broad array of drugs, including analgesics , antihistamines and decongestants , among many others.
The hypothesized mechanism of action by which zinc reduces the severity and/or duration of cold symptoms is the suppression of nasal inflammation and the direct inhibition of rhinoviral receptor binding and rhinoviral replication in the nasal mucosa. [1] Zinc has been known for many years to have an effect on cold viruses in the laboratory. [8]
Decongestant nasal sprays are advised for short-term use only, preferably 5 to 7 days at maximum. Some doctors advise to use them 3 days at maximum. A recent clinical trial has shown that a corticosteroid nasal spray may be useful in reversing this condition. [3] Topical nasal decongestants include: Oxymetazoline; Phenylephrine; Xylometazoline
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