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

Federal health officials warned manufacturers to cease marketing the products.

ByLISA STARK and KRISTINA FIORE<br>In collaboration with <a href="http://www.medpagetoday.com/"target="external">MedPage Today</a>
June 16, 2009, 2:09 PM

WASHINGTON, D.C., June 16, 2009&#151; -- When 45-year-old Mary Ann Brandon of Tyler, Texas, felt a cold coming on two years ago, she reached for a treatment she had never tried before -- Zicam nasal spray.

"I used one squirt in each side of my nose," said Brandon, noting that she used the product on the recommendation of a friend.

But rather than relief from her symptoms, Brandon said, she experienced excruciating pain.

"Within 30 minutes my husband and I were headed to the hospital," she recalled. "It burned my whole face, neck. I felt like I was on fire."

While she was able to reach the hospital for treatment for her reaction to the product,she says she was met with another bizarre side effect that has continued to this day.

"I got up the next day, ate, and could not taste a thing," she said. "It took about two weeks for the burning to go away. I had no taste or smell."

The U.S. Food and Drug Administration today 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 -- a condition known as anosmia.

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The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, said Dr. Charles Lee, medical officer at the FDA's Center for Drug Evaluation and Research.

The agency 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.

Matrixx issued a statement on the FDA's action on Tuesday afternoon. "[T]he company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products," the statement reads. "Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company's product safety data."

Regardless of the cause, anosmia can be more serious a problem that it sounds.

"The loss of sense of smell is serious," Lee said at a press briefing.

He said the loss of sense of smell "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 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."

Katie Rhodes, 39, said she is one of those people. Rhodes said she used Zicam just once and lost her sense of smell. She said getting used to the change was a major adjustment.

"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.

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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