Zicam recall: Manufacturer pulls intranasal cold remedy

-Examiner

06/25/2009 - That which we call a rose by any other name would smell as sweet—unless you’re one of the hundreds of people who say they lost their sense of smell after using intranasal Zicam cold remedies.

On June 16, the Food and Drug Administration cautioned consumers to stop using the following products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs and the already-discontinued Kids Size Zicam Cold Remedy Swabs.

Matrixx Initiatives—which has sold more than 1 billion doses since its intranasal products hit the shelves in 1999—“vigorously disagrees” that its products are unsafe, averring that consumers with the olfactory affliction didn’t read the directions and stuck the nozzle of the Zicam bottle too far up their noses.

Nonetheless, today (June 24,) Matrixx began informing consumers of a voluntary recall of the zinc-based nasal gel and gel swabs.

The Food and Drug Administration is a regulatory agency charged with watching out for the safety of Americans with regards to a number of industries.

The FDA oversees product approvals, manufacturing, labeling and safety in the areas of: biologics, which includes the safety of the nation’s blood supply; cosmetics; drugs (both over-the-counter and prescription); medical devices; radiation emitting electronic products; and veterinary products like food and drugs administered to pets and livestock.

The agency also keeps busy regulating bottled water and all food products save for raw agricultural products like fresh fruits, vegetables, whole grains, meat and poultry as well as sausages and processed meat products containing greater than two percent meat (these are overseen by the United States Department of Agriculture.)

The FDA began receiving complaints about Zicam-related loss of smell in 1999, but did not pursue the matter, according to a recent article in Time magazine. According to the article, this is partially due to the fact that the FDA does not regulate “homeopathic, non-drug products like Zicam, nor does it have the authority to enforce a product recall.”

It should be noted that the Food and Drug Administration has recalled a number of FDA-approved medications over the years, notably Fenfluramine. Fenfluramine was part of the anti-obesity medication coctail Fen-Phen, which was popular with dieters until it was withdrawn from the U.S. market in 1997 amid reports of pulmonary hypertension and heart valve disease.

the decade since the FDA was first alerted to issues with Zicam intranasal cold remedies, Matrixx kept the stink about loss of smell quiet. In 2006, Matrixx shelled out $12 million to settle with hundreds of people who say Zicam robbed them of their sense of scent.

One consumer crying foul is Greensboro, N.C. resident David Richardson. While Richardson has not filed a lawsuit, he has retained a personal injury lawyer and is one of the scores of people who have lodged a complaint about Zicam Cold Remedy with the FDA.

Like many of us, Richardson has often supplemented professional medical care and advice over the years with vitamins and supplements as well as over-the-counter homeopathic and complementary remedies like Echinacea.

Richardson says he only used Zicam for a cold once, back in 2005. After pumping the nasal gel into his nostrils and inhaling, he remembers feeling a burning sensation.

Richardson’s nose was already stuffy, so he chalked up his ensuing loss of smell to his cold. When his cold got better but his sense of smell remained elusive, he headed to the doctor’s office for an MRI.

Nothing unusual was found and Richardson’s sensory deprivation remained a mystery, until he looked up Zicam on the Internet and saw a slew of pending lawsuits from people who were in the same scentless boat.

A doctor has since tested Richardson’s sense of smell and affirmed that the problem may, indeed, be linked to Zicam. With the help of medical care, Richardson has gradually regained about 20 percent of his ability to smell.

He is still mourning the missing 80 percent, though.

"It's like watching a sunset in black and white,” Richardson told reporter Jeff Donn in an Associated Press article. “The things that you take for granted, not only smelling fresh-cut grass or bread in the oven . . . you miss those parts of your life. There's not a day that goes by that you're not reminded of it."

Anosmia (medical-speak for loss of smell), is nothing to sniff at. According to an article on the website of the Mayo Clinic, “loss of smell can cause people to lose interest in eating, leading to weight-loss, malnutrition or even depression.”

Loss of smell can pose a number of dangers even if the person with the condition manages to avoid the pitfalls of under-eating and of depression. If you have anosmia, you have lost a significant alert system: You can’t smell smoke, leaking gas, toxic fumes and food that has gone bad.

As many as 5 million American adults have disorders affecting their senses of taste and smell, according to the Anosmia Foundation website.

If you don’t wish to join them, you probably want to take any Zicam products that have been recalled out of your medicine cabinet and toss them. (Note: You can receive a refund or exchange your recalled product for one of Zicam's still-on-the-shelves oral remedies. To do so, call Matrixx's toll-free customer service line [877-942-2626] or visit www.zicam.com.)

Zicam was never billed as a product that could get rid of colds; instead, it was marketed as a product that could reduce the symptoms and duration of a cold if you took it soon after becoming ill.

Its recall, though, reminds all of us of an old saying that—despite some amazing medical advances—remains true:

There is no cure for the common cold.