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Zicam Recall Issued After FDA Warns About Risk of Loss of Smell

  • Written by: AboutLawsuits
  • 2 Comments

Matrixx Initiatives, the makers of Zicam, have announced they will comply with a FDA order to stop marketing nasal gel and swab versions of their over-the-counter cold remedy, voluntarily withdrawing two products from the market amid concerns that they could cause permanent loss of ability to smell.

The Zicam recall was issued after the FDA advised consumers on Tuesday to immediately stop using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Sizes.

Based on the FDA’s recommendation, Matrixx has notified consumers to discard any unused product or contact them to request a refund. Zicam Cold Remedy Kids Size Swabs were previously discontinued by Matrixx and are not included in the recall.

Although Matrixx agreed to voluntarily withdraw Zicam, they characterized the FDA’s actions as “unwarranted” and insist that Zicam side effects do not cause temporary or permanent loss of smell, known as anosmia. They indicate that the most common cause of anosmia is the common cold, and that there is no reliable scientific evidence that Zicam causes loss of ability to smell.

Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs accounted for about 40% of all sales for Matrixx Initiatives at the time of the recall. Following the FDA warning, the company’s stock price fell by more than $13, to just over $6.

The Zicam recall does not affect 17 other products bearing the brand name Zicam, including a number of oral medications.

The nasal gel swabs and spray versions of Zicam contain zinc gluconate, which can damage nerves in the nose and cause a loss of smell. However, Matrixx Initiatives indicates that Zicam does not deposit zinc deep enough into the nose to cause the smell problems.

Matrixx Initiavies has faced a number of Zicam lawsuits over loss of sense of smell and taste since the products were first introduced in 1999. Although the company maintains that no case has ever been lost in court, they have reportedly settled about 340 cases out of court for undisclosed amounts.

The FDA ordered Matrixx Initiatives to stop marketing Zicam nasal gel and swabs until they submit data establishing the safety and effectiveness of the cold remedy. The recalled Zicam products did not originally require FDA approval, as they were classified as homeopathic products, a classification usually reserved for herbal remedies. However, the FDA can force a company to have a product approved, regardless of classification, once a health concern has been identified.

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2 comments

  1. Cholesterol Reply

    Matrixx reports that it sold 35 million retail units of the products in question which equals about 1 billion doses. Of these, the FDA is focusing on 130 reports of problems. The percentage of people experiencing side effects, based on units sold is .0000037 percent — or .0000265 percent if you figure in the 800 “unreported” cases. It would even be more miniscule if it were calculated on the number of doses.

    Can FDA approved drugs claim this extremely low incidence of side effects?

    As a concerned consumer who likes to be informed, I sat in on the Matrixx conference call today. One reporter who has been covering this industry for 12 years noted that the FDA’s action was unprecendented and uncharacteristic. I also learned that Matrixx conducted 4 peer reviewed clinical studies in 2004 that showed no causal relationship between Zicam products and smell loss – something that has been rarely reported in coverage of this story. What IS known to cause smell loss is 1) the common cold, 2) sinusitis, 3) nasal injury. Aging also contributes to smell loss, just as our other senses become less sharp as we age.

    BTW – I do not work for Matrixx. I just like being fully informed about a product and a precedent that could have far reaching effects. Surely there should be a warning on the package insert about the possibility of anosmia – but the product should not be banned because some people have experienced problems. If so, what about peanuts, chocolate, shellfish, gluten and other food substances that have caused serious consequences or even death, and in much greater numbers than what is being reported for the Zicam products?

  2. mekesha Reply

    They have known about the negative side effect since 1991. All they care about is money not us. I wrote about Zicam too, check out my blog
    http://yovia.com/blogs/mekeshapryer/

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