Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc

FDA recommends that consumers stop using these products and throw them away

On June 16, 2009 The FDA issued the following product recall. The recall was triggered when the FDA received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia).  These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms.

The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, said Dr. Charles Lee, medical officer at the FDA’s Center for Drug Evaluation and Research.

The agency also issued a warning letter to Scottsdale, Ariz.-based drug maker Matrixx Initiatives Inc. to stop marketing the products and seek FDA approval if it wants to keep them on the market.

Matrixx issued a statement on the FDA’s action on Tuesday afternoon. “The company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products,” the 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.

Right about now, my Inconvenient Women readers are probably asking the same questioned that popped through my head when I read the FDA recall.

Are you telling me that the FDA will pull an over the counter product off the shelves for 130 adverse event reports; and will do NOTHING about the Merck HPV vaccine, Gardasil!

The families of the thousands of girls and young women who have suffered adverse effects after being injected with Gardasil, and those who mourn the over twenty young women who have died after taking the HPV vaccine have to be wondering, why the FDA moved so decisively to remove an over the counter cold medicine, yet the only consession the FDA has made about Merck’s Gardasil has been to issue a “Warning About Fainting” after the Gardasil injection. Am I the only one who thinks the FDA’s safety priorities are skewed? Looking at the Gardasil-related injuries,  the FDA recall of a cold remedy that has injured 130-people is a head-shaker. I’ve included the FDA contact information at the close of this Blog. Call or write the FDA if you feel they should be as proactive about the dangers posed by Merck’s Gardasil as they are over a cold medication that might effect a sense of smell.

Zicam Recall Information

FDA recommends that consumers stop using these products and throw them away.  See the FDA website for How to Dispose of Unused Medicines.

For treating symptoms of the common cold, consumers can take a number of other over-the-counter drugs.  However, the common cold goes away without treatment, usually within seven to ten days.

Since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, FDA has received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products.  The reports vary.  Many people state that the loss of sense of smell occurred with the first dose of the Zicam product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.

Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food.  Also, loss of the sense of smell is often linked with a loss of the sense of taste.  People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating.

FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

Contact Us
  • 1-800-FDA-0178 Fax
  • MedWatch OnlineRegular Mail: Use postage-paid FDA Form 3500

    Mail to: MedWatch 5600 Fishers Lane

    Rockville, MD 20852-9787

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.