Zicam Manufacturer Failed to Turn Over FDA Reports
Matrixx Initiatives Inc., manufacturer of Zicam brand cold remedies, failed to turn over 800 consumer complaints of serious side effects to the Food and Drug Administration (“FDA”) over a period of two years. The FDA recently issued a Zicam warning after it received 130 complaints directly from doctors and consumers linking Zicam swabs and nasal sprays to anosmia, or loss of smell. The FDA does not know whether these Zicam side effects are permanent, and the side effects can occur after just one use of Zicam products.
A 2007 mandate from the FDA required all companies to turn over any consumer complaints linking food or drug products to serious side effects. However, Matrixx maintains that the 2007 regulation does not apply to it because Zicam is a cold remedy, not a drug, and therefore not subject to FDA regulation. FDA spokespeople have asserted that Matrixx was bound by the 2007 government directive.
Several Zicam lawsuits have already been filed, and that number is expected to grow in the upcoming months. If you or someone you love has suffered a loss of smell after using Zicam nasal sprays or swabs, you may be entitled to compensation. Contact an experienced Zicam lawyer.
Tags: Zicam