FDA Advises Consumers Not To Use Zicam - Nasal Zicam....BAD!!!!

[Guest guest]

"JAMES GUTTROMSON" <charjimgNasal ZicamI want my friends and loved ones to know what has happened to me inhopes that it will never happen to you or anybody you care about. About10 days ago I felt a cold coming on so before I went to bed I used ZicamCold Remedy Nasal Gel. It's supposed to help you "get over your coldfaster". Immediately after I sprayed it into each nostril I felt themost horrific burning sensation imaginable. It literally felt like Ihad sprayed pepper spray directly into my brain. It burned all the way to the top of my skull. My nasal passages swelled, my eyeswatered - the burning lasted all night long into the next day. Afterabout a day I realized I couldn't taste anything and I thought "Wow - Imust really have a bad cold". Then I noticed that I couldn't smellcoffee brewing, couldn't smell my perfume when I put it on, couldn'tsmell the popcorn I burned, couldn't smell my favorite candle. Ipanicked and starting smelling everything that I could find that hadreally strong odors - ammonia, finger nail polish remover, bleach, etc.I couldn't smell ANYTHING! I started tasting everything that had reallystrong tastes such as HOT salsa, raw red onions, Doritos, coffee. Icouldn't taste ANYTHING!I told my mother about this and she said "Oh I've heard Zicam can affectyour Olfactory nerve". I went online, typed in "Zicam side effects" andbam - up popped all sorts of web sites with people reporting the same thing I experienced. It seems that this past June,Zicam pulled the swabs for adults and children off the shelf but not thenasal gel.I went to my ENT and he said the Zicam had basically "FRIED" myOlfactory nerve and the results are most likely permanent. He put me ina strong dose of a steroid called Prednisone in hopes of recovering ANYbit of the nerve damage but he told me to "take this and pray". He said he had read about the side effects of Zicam and couldn't believe it is still on the shelf. It isn't FDA approved. I am taking the Prednisone and praying but nothing is happening. I LITERALLY CANNOT SMELL OR TASTE ANYTHING! I can tell if foods are hot or cold, I can tell the consistency and I can faintly detect if it is salty but that is it. PLEASE PLEASE PLEASE pass this on to everyone you care about. I don'twant this to happen to ANYONE else!!!!!!!!!! and if you have Zicam in your medicine cabinet THROW IT AWAY!FDA NEWS RELEASEFor Immediate Release: June 16, 2009Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delanceyConsumer Inquiries: 888-INFO-FDAFDA Advises Consumers Not To Use Certain Zicam Cold RemediesIntranasal Zinc Product Linked to Loss of Sense of Smell The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. The products are: --Zicam Cold Remedy Nasal Gel --Zicam Cold Remedy Nasal Swabs --Zicam Cold Remedy Swabs, Kids Size (a discontinued product) The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. “Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.” People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment. The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance. Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone. --Online --Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 --Fax: 800-FDA-0178 --Phone: 800-FDA-1088For more information:http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm