Zicam Zinc Nasal Sprays May Damage Sense of Smell, FDA Says

"Socially, it was harder to interact," she said. "I couldn't enjoy food. I couldn't enjoy wine. Also, one of the things I most miss was I couldn't smell my children. I had to have my five-year old open the milk for me, or smell the milk for me to see if it was off."

FDA Asks Matrixx to Hand Over More Than 800 Reports

Lee said today that "while the number of adverse events may not seem high, we believe they are significant." He said the agency hasn't seen a corresponding number of anosmia reports with other common cold products.

Also, Lee said, consumers typically file complaints directly with the manufacturer, not the FDA.

Until 2007, there were no requirements for over-the-counter product manufacturers to provide adverse event reports to the agency.

In the warning letter, the FDA asked Matrixx to hand over more than 800 reports "that we know they have relating to loss of sense of smell associated with these products," Autor said.

Dr. Robert Henkin, a neurologist who directs the Taste and Smell Clinic in Washington, D.C., said, "It is wonderful and very good that the FDA had enough courage to do this. I just hope that it'll stick.

"The patients themselves have done everything they could to try to get some kind of action on the part of the government and, up until today, they had been fully unsuccessful," he added.

Henkin also said it's not simply a matter of patients losing their taste and smell, it also results in a distortion of those senses.

"This is devastating," he said. "It colors their whole lifetime. When they eat something or smell something it smells distorted or awful, sometimes rotten or chemical. It inhibits them from being able to eat or socialize."

The FDA first started receiving adverse event reports about the drug in 1999, but the majority came after 2004, Lee said.

In 2006, the company paid $12 million to settle 340 lawsuits brought by consumers who claimed the zinc nasal gel adversely affected their sense of smell.

Matrixx May Still Seek FDA Approval for Zicam

The FDA has given Matrixx 15 days to stop marketing the product and to come up with a plan for getting the product off the shelves. The FDA said if the company wants to continue selling the product, it needs to come in and try to seek approval as a new drug.

The zinc products are sold as homeopathic remedies, and Autor said that as part of the FDA's compliance policy guide, homeopathic drugs can "stay on market without FDA approval in certain circumstances if they are in compliance with labeling and manufacturing requirements."

In this case, Autor said, Zicam products containing zinc will now need FDA approval.

The agency stressed that the warning pertains only to zinc-bearing, intranasal Zicam products. That includes Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids Size -- the last of which has already been discontinued.

Lee said there is information from both the historical literature and animal studies that show zinc to be "toxic to nerve receptors within the nose. Damage to those receptors can cause anosmia."

Autor added that Matrixx has already conducted trials involving a small number of patients with regard to zinc-containing Zicam products, but said there were "not enough patients in those trials to detect adverse events."

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