FDA Reviewing Complaints Whether Nasal Spray Causes Loss Of SmellOct 6, 2004 | www.thedenverchannel.com Hundreds of consumers say Zicam has caused them to lose their sense of smell and now the Federal and Drug Administration is taking notice, 7NEW Investigator John Ferrugia said.
For the past year, doctors at the University of Colorado Health Sciences Center Taste and Smell clinic have been documenting the loss of smell among users of Zicam's intranasal spray, which contains zinc gluconate.
Hundreds of consumers claim they had a terrible burning sensation and totally lost their sense of smell after using the product.
Our 7NEWS investigation prompted the FDA to ask those affected to call the FDA hotline to report adverse effects.
7NEWS has learned that the FDA has now received more than 100 complaints about the Zicam spray and additional complaints about a similar product called Cold-Eeze.
An FDA spokesperson now confirms the agency is "conducting a final review in order to determine whether Zicam (zinc gluconate) is causing the instances of (loss of smell)" and, there is "an open investigation being deliberated within FDA."
But "no decisions have been made" with regard to action, the FDA said.
Both the makers of Zicam and Cold-Eeze claim their product is safe and the maker of Zicam said the FDA has yet to contact the company to inform it of an investigation. Even so, the company is redesigning the pump that injects Zicam nasal spray into the nose.