FDA Alerts Consumers Concering Zicam®
Jon L. Gelman LLC is investigating cases involving individuals who have suffered the loss of taste and smell (anosmia) after using Zicam®. Zicam® is an over-the-counter nasal spray used to relieve the symptoms associated with the common cold and flu and is manufactured by Matrixx Initiatives. Matrixx manufactures a range of products under the Zicam® name, but the name Zicam® is generally used to refer to its over-the-counter nasal zinc solution spray.
The following symptom has been associated with the use of Zicam®:
• Anosmia (loss of taste and smell)
If you or a loved one may have experienced anosmia in connection with Zicam® use, please contact attorney Jon Gelman at email@example.com or +1 973.696.7900.
Drug History and Serious Adverse Reactions
Zicam® is an intranasal, zinc solution spray inserted directly into the nostrils and is manufactured by Matrixx Initiatives, Inc. Matrixx
Initiatives also produces the following products:
• Zicam® Allergy Relief Nasal Gel
• Zicam® Cold Remedy Nasal Gel
• Zicam® Cold Remedy Swabs
• Zicam® Extreme Congestion Relief
• Zicam® Kids Size Cold Remedy Swab
• Zicam® Nasal Moisturizer
• Zicam® Sinus Relief
Zinc products fall under the FDA's homeopathic division and, therefore, do not require pre-market approval. In the late 1930s, zinc was used in Canada on 5,000 children during a polio outbreak. At that time, doctors were hopeful that the zinc would kill the polio virus as it entered the nasal cavity. The zinc spray, however, did not kill the polio virus. Rather, 25 percent of the children exposed to the nasal spray experienced varying degrees of taste and smell loss.
Some physicians have linked Zicam® with a total loss of taste and smell, or anosmia, and some users have reported having had a burning sensation in their nasal cavities immediately after using the product that was followed by a loss of smell and taste.
On June 16, 2009, the FDA issued a warning advising consumers to discontinue use and dispose of the Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size. The warning was in response to more than 130 reports received by the FDA involving the loss of sense of smell associated with the use of these Zicam products, including permanent damage. The agency also sent a letter to manufacturer Matrixx Initiatives, Inc., that acknowledged more than 800 reports submitted to the company regarding the loss of sense of smell with Zicam Cold Remedy products and requested a response and corrective actions within 15 days.
In spite of reports and medical opinions regarding the nasal spray as being linked to anosmia, the manufacturer has not warned the public of the risks. Dr. Terence Davidson, Director of the University of California Nasal Dysfunction Clinic, explains the potential dangers stating, "You put zinc on the olfactory receptor and you effectively kill the receptor. It's like pouring acid on an open wound.
In January 2006, Matrixx agreed to pay $12 million to settle 340 lawsuits brought by consumers who claimed that Zicam® Cold Remedy, the zinc nasal gel that is the company's flagship product, damaged or destroyed their sense of smell. The manufacturer denied that Zicam® was responsible and blamed a virus.
On April 11, 2006, The Federal Trade Commission (FTC) launched an inquiry into the advertising and promotion of Zicam® Cold Remedy and half a dozen similar over-the-counter cold products manufactured by Matrixx Initiative. The company disclosed the investigation in a filing to the Securities and Exchange Commission, saying it was designed to determine whether Matrixx engaged in "unfair or deceptive acts or practices."
FDA Warning: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm