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To: Jeffrey S. Mitchell who wrote (7368)2/21/2005 1:14:36 PM
From: Jeffrey S. Mitchell  Read Replies (2) | Respond to of 12465
 
Re: 2/21/05 - [MTXX] Mercury News: Zinc nasal sprays stir safety concerns; S.J. man says product cost him his sense of smell

Posted on Mon, Feb. 21, 2005

Zinc nasal sprays stir safety concerns

S.J. MAN SAYS PRODUCT COST HIM HIS SENSE OF SMELL

By Barbara Feder Ostrov

Mercury News

Not his wife's barbecued chicken. Not the sweet scent of the huele de noche plant that grows in his front yard. Not even the pungent Ben Gay ointment he rubs into his aching shoulders.

Ruben Flores says he hasn't been able to smell anything since using a popular zinc nasal spray to cut short a nasty cold two years ago.

Now Flores is suing the manufacturer -- as are hundreds of others around the country who say the same thing happened to them.

``Now I can't even smell microwave popcorn,'' said Flores, a UPS delivery person who lives in San Jose. ``If I had my sense of smell and taste back, I'd value that over anything.''

Widely available at drugstores, zinc nasal sprays are coming under increasing scrutiny amid a flurry of lawsuits and doctors' case reports linking them to a permanent loss of smell.

The U.S. Food and Drug Administration is evaluating complaints related to zinc nasal sprays, said spokeswoman Victoria Kao.

While science offers no definitive evidence on the risks of these products, a number of Bay Area doctors are cautioning their patients that the risk of permanently losing one's sense of smell isn't worth shaving a few days off a cold.

Flores used Zicam Cold Remedy Nasal Pump, a zinc gluconate gel product made by Matrixx Initiatives, a publicly traded Phoenix company. It's also available at pharmacies as lozenges, oral spray and nasal gel swabs -- which Rush Limbaugh recently touted as ``magic'' -- for about $9 to $12.

284 lawsuits

At least 284 lawsuits relating to these products have been filed against Matrixx, according to documents the company filed with the U.S. Securities and Exchange Commission. A Phoenix law firm says it's representing more than 300 patients in legal actions against Matrixx.

After similar lawsuits, Quigley, maker of Cold-Eeze zinc nasal spray, pulled it from the market, citing disappointing sales. But Matrixx vigorously defends its products and dismisses reports linking them to anosmia -- the medical term for permanent loss of smell -- as ``unfounded and misleading.'' A scientific panel convened by the company to examine the issue found insufficient evidence to link the products to a loss of smell.

``The company feels the product is safe,'' said Robert Murphy, a publicist working with Matrixx. He said the company's clinical research has never indicated any safety problems with Zicam Cold Remedy nasal products.

No studies found

There are no rigorous studies on whether zinc nasal spray users are at higher risk of losing their sense of smell, although some doctors have reported seeing patients who said they could no longer smell after using these products.

Some scientists believe that in certain quantities, zinc, an element found in almost every cell, may have an astringent effect that can damage cells in the nasal cavity that control the sense of smell.

Because there are so many potential causes of anosmia -- including severe colds, flu, infections, allergies and surgery -- Matrixx and some scientists believe people are unfairly blaming zinc nasal sprays for their loss of smell. Flores, for example, said he had been treated for sinus infections before using Zicam.

Zinc lozenges and oral sprays have been shown in some studies to shorten the duration of colds by a few days. The research on the effectiveness of nasal zinc products is mixed, with some studies showing that they shorten the common cold and others showing no effect.

Sales of these products are booming, and the Zicam zinc nasal products are hot sellers: Matrixx has said that more than 10 million people have bought them since they were introduced in 1999.

Flores, 56, was fighting a nasty cold when he used Zicam twice a day for two weeks.

``I felt a burning sensation in my nose, and my wife told me to stop using it,'' he said. ``I thought maybe it was supposed to be that way.''

Loss of smell

He didn't think much of it -- until he noticed a month later that he couldn't smell the BENGAY ointment he rubbed on a sore shoulder. He grabbed his wife's cologne and sniffed. Nothing. After a CT scan showed no obvious problems, Flores said, his doctor told him he might never recover his sense of smell.

Flores said his sense of taste has been diminished as well, leaving him unable to distinguish between steak and chicken or tomatoes and apples. Even his wife's beloved barbecue chicken ``tastes just blah,'' he said.

Flores has joined about 2.5 million Americans who are believed to suffer from a partial or complete loss of smell, according to the National Institutes of Health. There are no proven treatments to restore smell.

Dr. Andrew Goldberg of the University of California-San Francisco says zinc products taken by mouth, such as oral sprays and lozenges, appear to be safe. But he's warning his patients away from zinc nasal sprays until more research is done on their safety.

``My wife bought some and I threw it away,'' said Goldberg, who directs UCSF's Center for Clinical Research in Otolaryngology. ``I told her, `it's really not worth the risk.' ''

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Contact Barbara Feder Ostrov at bfeder@mercurynews.com or (408) 920-5064.

mercurynews.com