The Law Firm of Eric H. Weinberg is currently assisting individuals who believe they were injured as a result of using Zicam zinc-containing intranasal products. We are ready to help you. If you believe that you were injured as a result of using Zicam products, please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274.
Matrixx Initiatives, Inc., Slow To Issue Zicam Recall
On June 16, 2009, the FDA warned consumers to immediately stop using and discard zinc-containing Zicam intranasal products, because the products may cause a loss of sense of smell (anosmia.) These Zicam products are marketed by Matrixx Initiatives, Inc.
Zicam products were sold over-the-counter as cold remedies although the products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.
According to the FDA, the following Zicam products should not be used:
- Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
- Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
- Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)
Zicam Use and Loss Of Sense Of Smell (Anosmia)
The FDA has received more than 130 reports of loss of sense of smell associated with the use of the above Zicam products. The loss of sense of smell associated with Zicam use may be long-lasting or permanent. In addition, individuals have reported losing sense of smell after using Zicam for the first time and after using multiple doses of the product.
Loss of the sense of smell can also affect the ability to taste. The loss or impairment of the senses of smell and taste, poses both quality of life (inability to taste foods or enjoy fragrances) and safety (inability to detect danger signals such as smoke, gas, or spoiled food) issues.
The FDA Flexes Its Muscle
In addition to warning consumers to discontinue using Zicam zinc-containing intranasal products, the FDA has sent a warning letter to Matrixx Initiatives stating that these products cannot be marketed without FDA approval, and that the products do not include adequate warnings about the risk of loss of sense of smell.
This means that Matrixx Initiatives, Inc., was required, but failed to prove through clinical studies, that their products are both safe and effective. Additionally, the FDA’s letter to Matrixx Initiatives, Inc., indicates that FDA believes the company has withheld safety information from the public by not including a labeled warning indicating that there is a risk of loss of sense of smell associated with Zicam use.
What You Can Do
The FDA advises consumers to contact their health care professional if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products. The FDA also encourages consumers and professionals to report suspected Zicam side effects or product quality problems to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm, or by phone 800-FDA-1088.
If you or a family member was injured as a result of Zicam use, please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274. Since 1984, the Law Firm of Eric H. Weinberg has represented hundreds of individuals injured by dangerous and defective drug products. The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products, recovering over $750 million on behalf of the firm's clients.