The FDA announced today a warning concerning loss of smell associated with the use of the over the counter cold remedy, Zicam. The FDA has received reports of over 130 cases of ansomia, or loss of smell, associated with the use of Zicam. Zicam is an intranasal product that contains zinc. The agency urged consumers to quit using the product and to throw away any Zicam that they may already have at home. Zicam is marketed as an over the counter cold remedy that can shorten the length and severity of the common cold.

The effected products 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) (this has already been discontinued)

The products are sold in retail stores and pharmacies without a prescription. Zicam Kids Size has already been discontinued, but the FDA is concerned that some people may still have the product in their homes. The FDA has special concerns about the use of zinc in children. The anosmia that can be experienced by consumers can either be temporary or permanent.

The FDA sent a warning letter to Matrixx Initiatives, the manufacturer of Zicam, stating that they can no longer sell their product without FDA approval and that their warnings regarding the loss of the sense of smell are adequate. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance.

Anyone who has used this product and experiences a loss of the sense of smell should report the incident to their doctor right away. Any problems should also be reported to MedWatch. Consumers can report problems to MedWatch either online through the FDA’s website, or they can call at 1-800-FDA-1088.

For more information, see the FDA Consumer Update:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm166931.htm

The FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

The FDA Safety Information
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm

The FDA Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm166059.htm

Labels: anosmia, Common cold, FDA, MedWatch, zicam