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Health Agencies Update
April 28, 2010

Zicam Update

JAMA. 2010;303(16):1587. doi:10.1001/jama.2010.457

More than 800 additional reports of anosmia associated with the use of over-the-counter zinc-containing nasal products sold under the Zicam brand have been submitted to the US Food and Drug Administration (FDA) since the agency demanded the products be withdrawn from the market, according to an analysis by the Institute for Safe Medication Practices (ISMP).

The FDA's demand for the withdrawal of Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs in June 2009 came after the agency had received 130 reports of anosmia in individuals using the products, the first dating back to 1999. The flood of reports since then suggests that the scope and severity of the injuries associated with the products may have been greater than previously appreciated, according to the ISMP analysis (http://www.ismp.org/QuarterWatch/2009Q3.pdf). The report also noted that the manufacturer had received more than 1000 complaints about these products that it did not report to the FDA.

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