Warnings on Three Zicam Intranasal Zinc Products
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 program, either online or by phone at 1-800-FDA-1088.
SOURCE: FDA press release June 16, 2009
Last Editorial Review: 6/16/2009
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