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Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc podcast

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Run Time -- 00:03:42

On June 16, 2009, the Food and Drug Administration issued a public health advisory titled: Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc

I am Sherunda Lister from F-D-A’s Center for Drug Evaluation and Research.

FDA is issuing this advisory to alert consumers about the risk of permanently losing their sense of smell, known as anosmia, from zinc-containing cold remedies administered into the nose. This advisory does not concern zinc tablets taken orally and lozenges taken by mouth.

The zinc-containing products affected by this advisory are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and a discontinued product that consumers may have, called Zicam Cold Remedy Swabs, Kids Size.  All of these products are marketed by Matrixx Initiatives and are sold without a prescription to consumers to treat the common cold, which usually goes away without treatment within seven to ten days.

FDA sent a Warning Letter to Matrixx Initiatives advising it to stop marketing these products and to inform FDA of the actions that it will take to address those products already in the marketplace. 

FDA recommends that consumers stop using Zicam intranasal products and throw them away. 

There are other over-the-counter drug products for cold symptoms, which are FDA-approved for adults and older children. For children less than 2 years of age, over-the-counter cough and cold products are not approved, and should not be used, because they may cause serious and potentially life-threatening side effects. 

Since the introduction of zinc-containing products to the market in 1999, FDA has received more than 130 reports of anosmia associated with the use of zinc-containing intranasal products.  The reports vary in that many people state that the loss of sense of smell occurred with the first dose of the product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.

Loss of the sense of smell may cause serious problems.  People with anosmia may not be able to smell smoke, a gas leak, or spoiled food, for example.  Anosmia is often associated with a loss of sense of taste, or ageusia.  People need to be able to smell in order to taste properly.  People who cannot smell are not able to appreciate flavors, could eat spoiled food, and could lose much of the pleasure of eating.  Therefore, the effect of not being able to taste presents a potential danger and quality of life issue for anyone who experiences the problem of anosmia.  Loss of one’s sense of smell or sense of taste may also affect the work of people employed in the food industry, or other industries in which the sense of smell and taste are very important.

FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste after using any zinc-containing products that are administered into the nose.

We urge healthcare providers and patients to report adverse reactions such as a loss of sense of smell or taste from the use of zinc-containing products, to us at the FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash S-A-F-E-T-Y slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns  is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

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