After a strong warning from the FDA, Matrixx Initiatives has voluntarily withdrawn two Zicam zinc-containing nasal cold remedies due to a potential side effect that can destroy a person's sense of smell. Zicam is an over-the-counter cold remedy that was sold in many pharmacies and retail shops, but the FDA is now requiring Matrixx Initiatives, Inc., Zicam's manufacturer, to take steps to address this serious side effect.
If you or a loved one has suffered anosmia or any other negative side effects after using a Zicam product, please use the free case evaluation form to contact our Zicam attorneys now.
A Public Health Advisory was issued by the FDA on June 16, 2009 warning consumers that three Zicam Nasal Gel/Nasal Swab products are associated with a loss of sense of smell that may be long-lasting or permanent. This condition, known as anosmia, can also cause a partial reduction of the sense of taste. The agency also sent a warning letter to Matrixx Initiatives, Inc. stating that the company should stop selling these Zicam products and must seek FDA approval in order to continue marketing them. In addition, the letter states that the labeling on these Zicam products does not contain adequate warnings regarding the risk of anosmia associated with the product.
The FDA first received reports of a loss of smell linked to Zicam in 1999, when Zicam Cold Remedy Nasal Gel was introduced. To date, it has received over 130 reports of loss of sense of smell. The FDA also mentioned in the warning letter that it is aware that Matrixx appears to have received more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products. Approximately 400 Zicam lawsuits have been filed since 2003, and in 2006, Matrixx agreed to pay $12 million to settle claims by 340 plaintiffs who claimed their sense of smell was damaged or destroyed after they used the popular over-the-counter zinc nasal gel products.
Because Zicam is labeled as a homeopathic remedy and contains zinc, which is a naturally occurring mineral that is generally considered to be safe, it was exempt from the FDA regulations governing safety testing and manufacturing. In fact, many homeopathic products can be sold without FDA approval. However, due to the significant evidence that Zicam products could pose a serious risk to consumers, the FDA has stated that Matrixx must now seek FDA approval to continue selling its remedies.
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