Three Zicam products were recently identified by the U.S. <a href=”http://www.fda.gov/” rel=”nofollow”>Food and Drug Administration as posing a risk of anosmia, or loss of smell. This is a potentially debilitating condition, and the FDA is concerned that some cases of loss of smell may be permanent. According to an FDA warning issued on June 16, 2009, over 130 cases of loss of smell have been reported to the agency (hundreds more are suspected) - many of which occurred after the first dose with one of the following three Zicam intranasal products:

• Zicam Cold Remedy Nasal Gel
• Zicam Cold Remedy Swabs
• Zicam Cold Remedy Swabs, Kids Size

Each of these products is administered directly into the nasal cavity and contains a form of zinc as the active ingredient. The products are all marketed as reducing the symptoms associated with the common cold as well as their duration. This is not a claim supported by the FDA, however.

In fact, in a letter to the owner of Zicam products, the FDA noted that:?

• The risk of loss of smell was not adequately stated in the products’ warnings
• The products were misbranded
• The marketing of the products was done without FDA approval

The agency also noted that other widely-used intranasal cold products are more effective, carry a lower risk of loss of smell, and are marketed with FDA approval.

Have Zicam Caused You to Suffer Loss of Smell?

Both children and adults are at risk of suffering loss of smell with Zicam use, though children may be less likely to report it. Loss of smell can result in an inability to pick up on dangerous odors such as smoke, gas leaks, and rotten food. For those in the food industry, loss of smell can result in an inability to perform one’s work.

If you or your child has experienced a loss of smell after taking one of the zinc-containing Zicam products listed above, it’s best to see a doctor as soon as possible. You should also consider reporting the event to the FDA’s MedWatch program and talking to a Zicam lawyer.

Because Zicam did not adequately warn users regarding the risk of loss of smell with certain of its products, those who have suffered this side effect may be entitled to seek compensation in a legal action. Contact a medical attorney, today, to have your questions about Zicam and loss of smell answered in a free claim evaluation. ?

The Food and Drug Administration issued a warning on June 16, 2009 for three Zicam nasal products, including Zicam Cold Remedy Nasal Gel. According to the FDA warning, the popular cold remedies may pose serious risks to consumers. One such risk is the loss of smell (anosmia) - a serious and potentially permanent condition. The FDA said that it had received more than 130 reports of anosmia associated with Zicam Cold Remedy Nasal Gel and two other Zicam products, and it’s possible that hundreds of additional cases have been reported to Matrixx Initiatives, Inc., which owns Zicam.

Consumers who are in possession of Zicam Cold Remedy Nasal Gel are urged to discontinue use immediately.?

Reporting an Adverse Event

Zicam Cold Remedy Nasal Gel is an intranasal product, which means it is administered directly into the nose.? It is one of Zicam’s three over-the-counter, zinc-containing intranasal products - all of which are marketed as reducing the severity and length of the common cold in children and adults. However, this claim is not backed by the FDA and, in fact, in violation of FDA regulations.

The FDA recommends that consumers who have experienced loss of smell after using Zicam Cold Remedy Nasal Gel contact a physician and report the event to the agency’s MedWatch program. In its health advisory, the FDA said that many cases of loss of smell occurred with the first dose of Zicam, but it may happen with later doses as well.?

Zicam Problems Cited by the FDA

In a letter to Matrixx, the FDA stated that:

- Zicam Cold Remedy Nasal Gel and two additional zinc-containing Zicam products are not generally recognized as safe and effective

- The products are marketed without FDA approval

- The products do not contain adequate warnings about the risk of loss of smell and are misbranded

- In addition to loss of smell, some individuals have also reported experiencing loss of taste after using zinc-containing Zicam products

- Other widely used intranasal products - ones that are approved by the FDA - are safer and less side effects are reported

Contact a Lawyer

The loss of sense of smell can have devastating effects, particularly in children and those who work in the food industry. Those who have suffered this side effect after using Zicam Cold Remedy Nasal Gel may be able to take legal action against the product manufacturer. Learn more about your legal rights by contacting a medical attorney who has experience in these cases.?

Two Zicam nasal swab products - Cold Remedy Swabs, both Regular and Kids Size - were recently deemed by the U.S. <a href=”http://www.fda.gov/” rel=”nofollow”>Food and Drug Administration to pose serious risks to consumers. In a public health advisory warning issued on June 16, 2009, the FDA stated that both Swabs and Nasal Gel made by Zicam may cause a potentially permanent and debilitating condition known as anosmia.?

Anosmia and Zicam Cold Remedy Nasal Swabs

Anosmia is essentially the loss of the sense of smell and the FDA said it has received over 130 reports of this condition in users of zinc-containing intranasal Zicam products, including the Nasal Swabs. In addition to the 130 cases of anosmia reported to the FDA, potentially hundreds more have been reported directly to the product manufacturer.?

Anosmia can, for example, affect a person’s ability to:

• Smell smoke, gas leaks and other dangers
• Smell spoiled food
• Work in the food industry

The loss of sense of smell can occur in children and adults who use Zicam Nasal Swabs, and many users said the side effect occurred with the first dose. However, it is possible for a person to suffer loss of smell after multiple uses. The FDA also said it had received reports of loss of taste.

Consumers who have the Cold Remedy Nasal Swabs by Zicam should stop use and discard them. Those who have experienced side effects such as loss of smell should seek medical attention and also file a report with the FDA’s MedWatch program.

Inadequate Warnings

Among numerous problems with the Swabs (as cited by the FDA) is that the product does not contain adequate warnings regarding the risk of loss of smell. According to the FDA, Zicam Nasal Swabs are marketed without the agency’s approval, mis-branded, and generally not recognized as safe and effective for treating the common cold.?

If you or your child has experienced the loss of smell after using Swabs by Zicam or other zinc-containing Zicam product, you may be eligible to take legal action against the product’s maker.? To learn more about your legal rights, contact a medical attorney, today. Attorneys offer free claim evaluations and can inform you as to whether you may be entitled to compensation for your losses.??