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Nasal gel caused loss of smell, suits claim

Manufacturer agrees to settle with some, will contest others


Hundreds of people across the country blame a common over-the-counter cold remedy for taking that joy from them: Zicam nasal gel, which is designed to ease the symptoms and shorten the duration of colds.

Last month, Matrixx Initiatives Inc., of Phoenix, maker of the popular Zicam products for colds, flu, sinuses and allergies, agreed to pay $12 million to settle lawsuits involving 340 plaintiffs. They said they suffered anosmia, or smell loss, after using the zinc-based gel, which is put into the nose with a pump.

The company admitted no wrongdoing and vowed to continue to "vigorously defend itself" in court. Sixty-one additional cases are pending, some involving Zicam’s nasal swabs. The company’s sprays and lozenges are not at issue.

No plaintiffs or attorneys returned phone calls during the last week.

Matrixx spokesman Robert J. Murphy said the company had spent $12 million in legal fees since the first Zicam productliability suit was filed about 2½ years ago. He called the settlement, announced in the midst of cold season, "strictly a business decision."

And business is good. Matrixx’s net sales rose 40 percent to more than $46 million for the nine months ending Sept. 30, 2005, compared with the same period in 2004.

The firm makes 22 products in the $3.5 billion retail cough and cold category and says its nasal gel is the only one on the market. Last year, Matrixx introduced a gentler spray tip to replace the pump, but the pump can still be found on store shelves in some areas.

Zicam products are widely considered "alternative," rather than mainstream, and are classified by the Food and Drug Administration as homeopathic remedies. That means they can be marketed as drugs but are held to a lower standard for safety and effectiveness.

Despite repeated requests for details of Zicam users’ complaints, spokeswoman Laura Alvey said only that "the FDA continues to monitor and review reports. If the situation warrants, the agency will take proper regulatory action."

According to the FDA’s adverse-event database, 133 Zicam users reported having problems in 2004, the latest year available.

Most involved the nasal gel and loss of smell, but because smell heavily influences taste, these people likely also suffered taste loss.

Zicam directions say to place the tip of the pump or swab just inside the nostril, apply the gel, and press lightly on the outside for about five seconds. "To avoid possible irritation," the pump box says, "do not sniff up gel."

The company blames its legal troubles on Bruce W. Jafek, an ear, nose and throat specialist at the University of Colorado School of Medicine, who in 2003 reported seeing 10 Zicam gel patients who had lost their sense of smell.

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