WASHINGTON, June 16 — The FDA has warned patients to stop using zinc-containing Zicam intranasal cold remedy products in light of reports of anosmia, the agency announced today.

The agency also issued a warning letter to Scottsdale, Ariz.-based drugmaker Matrixx Initiatives to stop marketing the products, and the company must now seek FDA approval in order to keep them on the market.

“The loss of sense of smell is serious,” Charles E. Lee, M.D., medical officer at the agency’s Center for Drug Evaluation and Research, said during a press teleconference. “[It] . . . is potentially life-threatening and it may be permanent.”

Dr. Lee said anosmia can be dangerous if patients can’t detect gas leaks or smoke from a fire, or can’t tell whether food is spoiled before eating it.

The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, Dr. Lee said.

“While the number of adverse events may not seem high, we believe they are significant,” he said, explaining that the agency hasn’t seen a corresponding number of anosmia reports with other common cold products.

Also, he 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,” said Deborah M. Autor, director of the office of compliance at the Center for Drug Evaluation and Research.

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

While the FDA has asked the company to stop marketing the products, the agency said it will “work with Matrixx to address products on the market,” and will allow the firm to seek FDA approval in the future.

The zinc products are sold as homeopathic remedies, and Autor explained 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.

Dr. 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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