The US Food and Drug Administration (FDA) on Tuesday warned consumers to stop using three Zicam intranasal cold remedy products containing zinc after continuing reports that some users have lost their sense of smell.
The over-the-counter products are: Zicam Cold Remedy Nasal Gel Zicam Cold Remedy Nasal Swabs Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
The FDA also issued a warning letter to Scottsdale, Ariz.-based drug maker Matrixx Initiatives Inc. to stop marketing the products and seek FDA approval if it wants to keep them on the market.
“The loss of sense of smell is serious,” Dr. Charles Lee, medical officer at the agency’s Center for Drug Evaluation and Research, said at a press briefing.
He said the loss of sense of smell, known medically as anosmia, “is potentially life-threatening and it may be permanent.”
“People without the sense of smell may not be able to detect dangers, such as gas leaks or something burning in the house and may not be able to tell if food is spoiled before eating,” said Deborah Autor, director of the US office of compliance at the Center for Drug Evaluation and Research.
“People who cannot smell are also not able to appreciate flavors and could lose much of the pleasure of eating, adversely impacting their quality of life.”
The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, Lee said. “While the number of adverse events may not seem high, we believe they are significant,” Lee said, explaining that the agency hasn’t seen a corresponding number of anosmia reports with other common cold products.
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, “I am surprised the FDA has done this.
I think it’s great. I hope it sticks.” 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 US 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.(agencies)