[Clinicians] FW: Public Health Message- ZICAM warning, please share

[Shannon Kolman]

Hello CHAMPS Clinicians' Listserv Members,


Below is some important information about FDA warnings against the use
of certain Zicam products.  You can also click on the FDA's Consumer
Updates page at the bottom of this email for more information.

 

Shannon Kolman, MBA

Clinical Programs Director

Community Health Association of Mountain Plains States (CHAMPS)
www.champsonline.org <http://www.champsonline.org/> 

Ph: 303-861-5165 ext. 236

 

The mission of CHAMPS is to support all Region VIII (CO, MT, ND, SD, UT,
WY) federally-funded Community Health Care Centers so they can better
serve their patients.

 

 

From: Konsella, Laurie (HHS/OPHS) [mailto:Laurie.Konsella at hhs.gov] 
Sent: Tuesday, June 16, 2009 11:55 AM
Subject: FW: Public Health Message- ZICAM warning, please share

________________________________________________________________________
_______________________________________________        

On June 16, 2009, the Food and Drug Administration (FDA) warned
consumers to stop using and discard three zinc-containing Zicam
intranasal products. The products may cause a loss of sense of smell.

Intranasal products are administered through the nose.

What products are affected by this warning?
FDA's action affects Zicam's three intranasal products that contain
zinc. The three Zicam products claim to reduce the duration of the
common cold and the severity of cold symptoms.

The products (listed with their size and product numbers) are

* Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
* Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
* Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

The Zicam intranasal zinc products are widely sold in pharmacies, other
retail stores, and on the Internet. Zicam Cold Remedy Swabs, Kids Size,
has already been discontinued, but FDA is concerned that consumers may
have the product in their home. FDA has special concerns regarding use
of intranasal zinc in children. Children may experience a loss of sense
of smell but may be less likely to communicate the condition.

Why did FDA take action?
The agency has received more than 130 reports of anosmia-the loss of
sense of smell-associated with use of these three Zicam products.

Many people who experienced a loss of sense of smell say that the
condition occurred with the first dose, although some people have
reported loss of sense of smell after later doses. FDA is concerned that
the loss of sense of smell may be permanent.

What steps did FDA take?
* FDA issued a public health advisory warning consumers to stop using
and discard or return the Zicam zinc-containing intranasal products.

* The agency sent a warning letter to Matrixx Initiatives advising the
firm that these products cannot be marketed without FDA approval. The
warning letter also states that the products do not include adequate
warnings about the risk of loss of sense of smell.

What should consumers do if they experience harm related to these
products?
FDA recommends they contact their health care professional if they
experience loss of sense of smell or other problems after using any
zinc-containing products that are administered into the nose.

The agency asks health care professionals and consumers to report
possible cases of loss of sense of smell or other problems after use of
these products to FDA through the MedWatch
<http://www.fda.gov/Safety/MedWatch/default.htm>  program, either online
or by phone at 1-800-FDA-1088.

This article appears on FDA's Consumer Updates page
<http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm> , which
features the latest on all FDA-regulated products.

 

Date Posted: June 16, 2009

 

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://champslists.org/pipermail/clinicians_champslists.org/attachments/20090617/63a6cefd/attachment.html>