The FDA recently sniffed out three products that cause consumers to lose their sense of smell: Zicam Cold Remedy nasal gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, kid-size, were all found to contain zinc, an ingredient scientists say damages nerves in the nose that are needed to smell. So far, the FDA has reported that about 130 consumers have reported a loss of smell from their use of the products.
The FDA issued a warning letter to Matrixx, the company that manufacturers Zicam, to stop distribution of the products, but the FDA has yet to issue a formal recall. Instead, Matrixx will have to submit safety and effectiveness data on the drug. Following the submission of that data, Matrixx will be required to seek FDA approval if it wishes to continue marketing its Zicam products. Prior to these safety issues, Zicam has never been required to have FDA approval because the products are considered homeopathic, meaning the formulation potentially contains herbs, minerals and flowers.
Matrixx has settled hundreds of Zicam lawsuits in the past, but they maintain in a statement on their website that no plaintiff has ever won a court case because they claim that there is no proven link between the use of Zicam and the loss of smell. They recently stated that they will consider withdrawing the Zicam products from the market. All of the consumer complaints the FDA has received have come from physicians and patients, and not the manufacturer.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.