Re: 3/3-6/05 - [MTXX] AP: Cold-remedy confusion may prompt new rules; Chicago Sun Times: Lawsuit claims zinc spray destroyed sense of smell
Cold-remedy confusion may prompt new rules
By Associated Press | March 4, 2005
CHICAGO -- Standing in a chain drugstore, Beth McClanahan considered the product Zicam. ''I wouldn't have known it was homeopathic," she said. ''Zicam sounds very scientific."
Stuffy noses and sore throats drive many to herbal and homeopathic remedies. But like McClanahan, consumers may not realize they're buying alternative medicines when they choose wildly popular products such as Airborne and Zicam -- both shelved alongside conventional medicines.
The makers of both kinds of medicines have paid for studies to test their products. But Airborne and Zicam have not been reviewed for safety and effectiveness by the Food and Drug Administration, unlike prescription and new over-the-counter drugs. The law allows their sale until the FDA proves them harmful.
''I think it's quite confusing for consumers to try to sort out which things have some data showing they actually work," said Dr. Ronald B. Turner, a cold virus expert at the University of Virginia.
Homeopathic products are labeled as such. Zicam, which contains zinc, is the third-leading nasal spray. Airborne is an effervescent tablet containing Chinese herbs and echinacea.
''There's a reason for the success of these products. Consumers want them, and they're effective," said Rider McDowell, cofounder of the company that created Airborne. But the Institute of Medicine wants tougher rules to make sure they're safe and effective.
And Steven Dentali of the American Herbal Products Association says his group wants new rules, such as mandatory reporting of adverse side effects. ''We think our safety record's going to look pretty good," he said, compared to some prescriptions.
© 2005 The New York Times Company
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Lawsuit claims zinc spray destroyed sense of smell
March 6, 2005
BY JIM RITTER Health Reporter
A Chicago woman is suing the manufacturer of an over-the-counter cold remedy that she says caused her to lose her sense of smell.
Diane Horvat, 38, said she used a zinc-based remedy called Zicam as directed last August, felt a burning sensation in her nose "and immediately noticed she had no sense of smell," said her attorney, G. Grant Dixon.
Horvat never will be able to enjoy "the true pleasures of life, from a bottle of wine to good perfume," Dixon said.
Her lawsuit, filed Monday in Cook County circuit court, is one of an estimated 300 filed nationwide, according to Robert Murphy, a spokesman for the manufacturer, Matrixx Initiatives.
"The company believes the product is safe and effective and will be vindicated in the courts," Murphy said.
Between 2 percent and 3 percent of the population suffer loss of smell, Murphy said. Other factors besides Zicam are likely to be the cause of any loss of smell suffered by Horvat and other plaints, he said -- such as sinusitis, nasal injuries or bad colds.
Zicam is a homeopathic remedy. Each dose contains less than 3 millionths of a gram of zinc gluconate. One bottle retails for between $10 and $13.
Last year, a study at the University of Colorado smell and taste center reported that seven men and three women between 31 and 55 years old reported a loss of smell after taking zinc gluconate. The researchers described only one case in detail.
Three company-sponsored studies have cleared Zicam, Murphy said. A population study found that, though 11 million bottles of Zicam have been sold since 1999, there's been no corresponding spike in the number of people who have lost their sense of smell.
The company spokesman said a second study found that lab rats that received up to six times the recommended dose of Zicam had no loss of smell. And he said a third study found that, when Zicam is sprayed into the nose, it doesn't even reach the upper area of the nasal cavity where smell reception occurs.
A spokeswoman for the Food and Drug Administration said the federal agency is evaluating complaints related to zinc nasal sprays.
Copyright 2005, Digital Chicago Inc.
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