The email pasted below was sent out by a victim of ZICAM to warn us all.
I followed the link in her email to the FDA webpage about ZICAM (also pasted below) and saw for myself the FDA’s warning about certain forms of the product, ZICAM Nasal Gel and ZICAM Nasal Swabs. I thought to myself, “surely these products are no longer on the shelf.” It had always seemed unlikely to me that there would be any such product available on the shelf that had not received prior FDA approval. The government cares about us… after all.
…. (whimpers) eh?
So I called my local Rite-Aid TODAY (January 20th, 2010) and confirmed the shocking truth: they ARE THERE!
Despite an FDA letter issued last June (2009) to the maker of ZICAM, Matrixx Initiatives, “warning” (wha?) them that they cannot market a product that has not received FDA approval, and despite the FDA’s acknowledging that it had received more than 130 reports (as of last June!) of loss of smell, the FDA, rather than taking action to ban their sale until such approval is met, has seen fit only to post a public advisory on their website (updated last on January 4th, 2010) advising the public not to use these products “for any reason” as they have confirmation that they CAN BURN your olfactory nerves …. PERMANENTLY.
The FDA merely encourages people who should be harmed by these products to report that fact to them at the FDA’s “MedWatch Adverse Event Reporting program.”
People!! We are being used as GUINEA PIGS! … worse still … even AFTER at least 130 cases were documented as of June 2008!! If not that, then what?? Is the FDA getting some kickback (read, “bribe”) from Big-Pharma profits at the expense of the public’s, as the FDA put it, “quality of life“?? How many cases of permanent damage does it take?? Does this sound more and more like a case of deliberate malicious mayhem on the part of the Food and Drug Administration?
The Rite-Aid pharmacist was concerned, I’ll give him that, saying he’d definitely look into the matter. He rather unthinkingly intimated, however, that since the FDA had not issued a ban, the onus is upon the consumer to know the risk before purchase. !! eh?? I did counter, believe you me.
Says Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, (CDER),
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms. 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.”
Where is the sense in that? I don’t know about you, but I haven’t gotten the memo yet. Perhaps the FDA thinks that everyone is equipped with that computer-chip implant in the brain that downloads reference data upon command.
For my part, I don’t use chemical cold products, preferring to rely upon Golden Seal tea and powder, Cayenne Pepper, Vitamin C, plenty of sleep and fluids. I get rid of a full-on cold typically in three days this way. I firmly believe that chemical cold “remedies” actually suppress the immune system and prolong the duration of colds, all for the trade-off of stifling the symptoms during the cold. Sometimes, if I begin to feel the throat symptom of a cold coming on, I’ll take GNC brand Zinc/Vitamin C throat lozenges, particularly overnight under my tongue, thereby nipping a cold in the bud.
The woman writing below tells of how she learned the hard way that ZICAM’s nasal gel is very, very dangerous.
FDA NEWS RELEASE
For Immediate Release: June 16, 2009
Media Inquiries: Siobhan DeLancey, 301-796-4668, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
Intranasal 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.
–Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787