FDA Sticks to Zicam Cold Remedy Warning Letter on Loss of Smell

October 27, 2009
By Gabriel Mejia, Esq. on October 27, 2009 10:59 AM | | Comments (0)

The U.S. Food and Drug Administration (FDA) has refused to back down from a warning letter sent to Zicam manufacturers, Matrixx Initiatives, Inc., regarding the potential dangers of its over-the-counter cold medication.  In June 2009, the FDA warned consumers that three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size (discontinued product) -- were associated with 130 reports of the loss of sense of smell (also known as anosmia).  According to the FDA, the loss of sense of smell reportedly occurred after the first dose of the drug, but is also known to occur after multiple doses.

The potentially dangerous Zicam products contain zinc gluconate (labeled "zincum gluconicum") as the active ingredient.  The FDA warns on its website that although these products are marketed to reduce the duration and severity of the common cold, the products have not been shown to be effective in doing so.  Consumers are advised not to use the potentially dangerous drugs for any reason and to throw away any remaining product.  Matrixx Initiatives has since pulled the products in question from the market, but the FDA fears that unknowing consumers will use products still stored in their medicine cabinets.

In the June 2009 warning letter, the FDA accused Matrixx Initiatives of failing to provide any data to establish that Zicam Cold Remedy intranasal products are safe and effective for the uses identified in their labeling.  On the contrary, the FDA said that there is published scientific literature that evidences various salts of zinc can damage olfactory function in humans.

The FDA also stated that Matrixx Initiatives failed to obtain an FDA-approved application which was necessary for the Zicam products in question despite their homeopathic status and marketed the potentially dangerous drug without FDA approval.  The FDA also claimed the Zicam products associated with the loss of sense of smell were misbranded because their labeling did not contain adequate warnings regarding the risk of anosmia (or loss of sense of smell).  The FDA also suggested that Matrixx Initiatives had an additional 800 reports associating Zicam Cold Remedy intranasal products to the loss of sense of smell which were not disclosed to the FDA.

If you have taken one of the Zicam products in question and experienced a loss of sense of smell, it is important to contact a health care professional and seek medical attention.  The loss of smell can cause serious hardships in a person's life such as the inability to appreciate dangerous gases, smoke, or spoiled food.  The loss of smell is often also accompanied by a loss of taste.  If you have lost your sense of smell after taking either Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, or Zicam Cold Remedy Nasal Swabs, Kids Size, an attorney experienced in handling defective and dangerous product cases can help you understand your rights and fight for the compensation you may be legally entitled to.

Gabriel Mejia, Esq. is a Coral Springs personal injury attorney handling accident and injury cases in Florida for Law Offices Cytryn and Velazquez, P.A.

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