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.?

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