Recently, the FDA advised consumers to stop using Zicam intranasal products, including Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs (Kids Size). These products contain the active ingredient zinc gluconate and are manufactured by Matrixx Initiatives, Inc., which had been marketing and selling the products as over-the-counter homeopathic cold remedies.
According to the FDA’s News Release and its Warning Letter to Matrixx, these intranasal products may be causing temporary and permanent loss of smell (known as “anosmia”). The agency has received more than 130 reports from people suffering this condition after one or several doses of the Zicam intranasal products. Additionally, the agency believes that the company has received in excess of 800 such reports.
In its warning letter to Matrixx, the FDA recognized that many drugs are marketed and sold as homeopathic remedies without FDA approval, consistent with the agency’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15).” However, the warning letter advises Matrixx that this policy guide does not exempt purported homeopathic remedies from “new drug” regulation by the FDA when there is evidence of a safety risk. In light of the lack of scientific evidence of safety and efficacy in these products – and the volume of smell-loss reports received by the FDA – the agency intends to treat Matrixx’s Zicam intranasal products as “new” drugs for which a New Drug Application (NDA) will be required. The agency also considers the products to be misbranded because there is not adequate labeling to advise users of the risk of loss of smell.
Several products liability lawsuits have been filed against Matrixx already, and there are also claims that third-party suppliers of these products – such as pharmacies – are responsible for not recalling, or at least warning about, these intranasal products.
If you or a loved one has used one of the Zicam intranasal products – either Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, or Zicam Cold Remedy Swabs (Kids Size) – and experienced any loss of smell, you may have a legal claim for damages. We are interested in hearing your story. If you would like to discuss your case with an attorney, please call our firm at (610) 941-4204 or visit us at our website at www.pbmattorneys.