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FDA Crackdown on Zicam

Posted by Jane Akre
Tuesday, June 16, 2009 11:34 PM EST
Category: Major Medical, Protecting Your Family
Tags: Zicam, Product Liability, Food and Drug Administration, Nasal Cold Spray

Zicam, the homeopathic over-the-counter nasal cold remedy must be removed from the shelves because of reports that people have lost their sense of smell.  

Zicam Nasal Cold Remedy

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IMAGE SOURCE:  Zicam/ Zicam Web site

 

For fans who won't leave home without it, the news is bad for their favorite cold remedy, Zicam. 

The Food and Drug Administration (FDA) is ordering the maker of Zicam to cease marketing the little bottle with the big nasal spray after continuing reports that some users have lost their sense of smell.

In a letter to drug maker, Matrixx Initiatives Inc., the FDA said the company must stop marketing the products because they are misbranded and fail to adequately warn of risks.

Here are the three over-the-counter Zicam products affected:

  • Zicam Cold Remedy Nasal Gel
  • Zicam Cold Remedy Nasal Swabs
  • Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
     

The FDA has reportedly received more than 130 reports of the loss of smell, also known as anosmia, which can render someone vulnerable if they cannot smell spoiled food or smoke from fire, for example.

The nasal spray delivers the homeopathic ingredient, zinc gluconate, a naturally occuring mineral, directly into the nasal passages where it can be immediately absorbed.  The package instructions are very precise that the bottle nose should be placed barely inside the nostril and pointed to the outside of the nasal passage.

Dr. Charles Lee, at the FDA’s Center for Drug Evaluation and Research believes that zinc may damage nerve receptors which can lead to anosmia. 

Since Zicam was first introduced in 1999, the company says more than 35 million units and over 1 billion doses have been sold.  130 complaints pale in comparison, but the FDA believes Matrixx has received 800 additional adverse reports that consumers have called into the Scottsdale, Arizona-based company, and it wants them turned over.

Zicam’s other oral cold remedies RapidMelts, Oral Mist, and Chewables are not affected by the warning because they are ingested. 

The company says the FDA action is unwarranted. “[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,"a 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."

Approved or Not Approved?

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of homeopathic remedies that are not required to undergo federal review because they are generally recognized as safe (GRAS).  

But Zicam’s online information says homeopathic drugs are drugs by law and, “Zicam Cold Remedy products are regulated by the U.S. Food & Drug Administration.”

The Homeopathic Pharmacopeia of the United States (HPUS) sets guidelines and standards for the source, composition and preparation of homeopathic drugs and the groups says it works closely with the FDA  and other homeopathic organizations to set standards for over-the-counter homeopathic drug products.

Homeopathy stimulates the body to turn on its own healing mechanism and has been used since the eighteenth century.

Many fans of Zicam write on U.S. News that it has been a life-saver in cutting down on the number and severity of colds. 

One fan writes, “My guess is that many applied it incorrectly thinking the more the better and inserting it more than 1/8" up nostrils. They put all sorts of warnings on cigarette and liquor packages and still let people buy the products. Can't they do the same for a really useful product?” 

 

What’s Next

This is not a formal FDA recall and over the next 15 days, Matrixx must stop marketing Zicam and tell the FDA how it plans to get the product off store shelves. Consumers can return products to the store for a full refund.  That may not be a problem as online fans say they will make a run for the remaining supplies of Zicam. 

In the future, if Matrixx wants to make Zicam the company must seek FDA approval for nasal formulations that contain zinc gluconate.  

In 2006, Matrixx paid $12 million to settle 340 lawsuits brought by consumers who claimed to have lost their sense of smell.  The company says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

The company’s (Nasdaq: MTXX) price plunged to a 52-week low after the FDA announcement. Matrixx says Zicam accounts for about 40 percent of the company’s $111 million in net sales last year.   

The high-profile move is among the first by new FDA Commissioner Margaret "Peggy" Hamburg and Deputy Commissioner Joshua Sharfstein, who promise to be more aggressive in enforcement action.  #


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