Comments on: FDA Issues Warning Over Matrixx Intiatives’ Zicam http://blog.pharmtech.com/2009/06/16/fda-issues-warning-over-matrixx-intiatives%e2%80%99-zicam/ The blog of Pharmaceutical Technology magazine Fri, 12 Mar 2010 00:24:37 -0500 http://wordpress.org/?v=2.8.4 hourly 1 By: Maribel Rios http://blog.pharmtech.com/2009/06/16/fda-issues-warning-over-matrixx-intiatives%e2%80%99-zicam/comment-page-1/#comment-15183 Maribel Rios Thu, 25 Jun 2009 15:30:18 +0000 http://blog.pharmtech.com/?p=1432#comment-15183 Frequently asked questions about the recall are now posted at: http://www.zicam.com/FDAwarningletterfaq Frequently asked questions about the recall are now posted at:
http://www.zicam.com/FDAwarningletterfaq

]]> By: Maribel Rios http://blog.pharmtech.com/2009/06/16/fda-issues-warning-over-matrixx-intiatives%e2%80%99-zicam/comment-page-1/#comment-14805 Maribel Rios Wed, 17 Jun 2009 16:56:07 +0000 http://blog.pharmtech.com/?p=1432#comment-14805 Thank you for your comments. As an update, the company has announced that it will voluntarily withdraw Zicam Cold Remedy Swabs and Zicam Cold Remedy Nasal Gel. Matrixx Initiatives have agreed to comply with FDA requirements and is seeking a meeting with the agency. The company insists there is no causal link between its Zicam Cold Remedy intranasal products and anosmia, and it reports more than 1 billion doses have been sold since 1999. Thank you for your comments. As an update, the company has announced that it will voluntarily withdraw Zicam Cold Remedy Swabs and Zicam Cold Remedy Nasal Gel. Matrixx Initiatives have agreed to comply with FDA requirements and is seeking a meeting with the agency. The company insists there is no causal link between its Zicam Cold Remedy intranasal products and anosmia, and it reports more than 1 billion doses have been sold since 1999.

]]> By: Heather Stephens http://blog.pharmtech.com/2009/06/16/fda-issues-warning-over-matrixx-intiatives%e2%80%99-zicam/comment-page-1/#comment-14801 Heather Stephens Wed, 17 Jun 2009 15:09:45 +0000 http://blog.pharmtech.com/?p=1432#comment-14801 I have used Zicam nasal gel spray and swabs for colds for the past 7-8 years. I have always followed the directions for use on the package. During that time, I have not experienced any loss of smell or taste, either during or following use of the product. In fact, I can confidently report that both senses are acute and intact. The product has been extremely effective in reducing the length and severity of cold symptoms and has hugely improved my feelings of health and well-being when I have the common cold. I have recommended this product to many people, and no one has ever mentioned any adverse reaction after use. I have written to the FDA, urging them to allow continued marketing of Zicam nasal gel products; if appropriate, a warning could be placed on the package. In my opinion, after long-term, occasional use of this very effective therapy, the benefits far outweigh the risks. I have used Zicam nasal gel spray and swabs for colds for the past 7-8 years. I have always followed the directions for use on the package. During that time, I have not experienced any loss of smell or taste, either during or following use of the product. In fact, I can confidently report that both senses are acute and intact. The product has been extremely effective in reducing the length and severity of cold symptoms and has hugely improved my feelings of health and well-being when I have the common cold. I have recommended this product to many people, and no one has ever mentioned any adverse reaction after use. I have written to the FDA, urging them to allow continued marketing of Zicam nasal gel products; if appropriate, a warning could be placed on the package. In my opinion, after long-term, occasional use of this very effective therapy, the benefits far outweigh the risks.

]]> By: yetta http://blog.pharmtech.com/2009/06/16/fda-issues-warning-over-matrixx-intiatives%e2%80%99-zicam/comment-page-1/#comment-14781 yetta Wed, 17 Jun 2009 00:45:34 +0000 http://blog.pharmtech.com/?p=1432#comment-14781 My family (young son and very elderly mother) and I have used Zicam swabs since they were introduced. We use them AS DIRECTED and have never experienced any problems. Used as directed, the swab does not touch the more sensitive upper nasal membrane. I would be very interested to know if the persons experiencing the anosmia has used the product(s) following the explicit directions accompanying Zicam products or if this is yet another result of persons not following dosing instructions. I would be dismayed if this product were to stop being sold as it certainly has helped us remain on the plus side of weathering seasonal colds. My family (young son and very elderly mother) and I have used Zicam swabs since they were introduced. We use them AS DIRECTED and have never experienced any problems. Used as directed, the swab does not touch the more sensitive upper nasal membrane. I would be very interested to know if the persons experiencing the anosmia has used the
product(s) following the explicit directions accompanying Zicam products or if this is yet another result of persons not following dosing instructions.

I would be dismayed if this product were to stop being sold as it certainly has helped us remain on the plus side of weathering seasonal colds.

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