Users of a recalled cold medicine have filed a pair of class action lawsuits, alleging that, instead of easing their sniffles, the medication permanently impaired their sense of smell.
On June 15, the Food and Drug Administration (FDA) warned consumers to stop using two types of Zicam cold medicine, after receiving over 130 complaints from consumers whose sense of smell was wiped out or severely diminished from having taken the medication. The side effect was blamed on Zicam's use of zinc gluconate, which can damage intranasal tissue.
In a press release, the FDA warned that the loss of smell known in medical circles as asomnia may be long-lasting or permanent. The release also stressed that asomnia can occur after taking just one dose of the medicine; indeed, many of the complaints received by the FDA were from first-time users. The FDA's Dr. Janet Woodcock warned that, Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms. Maatrix Initiatives, Inc., which manufactures Zicam, began a recall on June 24.
While losing one's smell has obvious effects on the quality of life, it can also lead to more serious and even life-threatening problems. Those with asomnia are unable to detect dangerous odors such as smoke or gasoline. Sense of taste, closely related as it is to smell, can also be affected.
The suits were filed in federal court in California and state court in Missouri. The California suit, led by plaintiff Barbara Sample, was brought on behalf of anyone who bought Zicam while in California, or from a manufacturer or other source in California, within the four years preceding June 23, 2009. The Missouri suit defines a class of all St. Louis County residents who bought the product in the year preceding the FDA bulletin, and is led by plaintiff Gwendoly West.
The California suit alleges that Maatrix concealed or omitted material information regarding the safety of the nasal gel products.
The class actions may be just the tip of the iceberg for Maatrix. The company also faces Zicam-related actions in Arizona, Illinois, Florida, Texas, Minnesota, and Wisconsin. The FDA also says that Maatrix never handed over 800 internal complaints from consumers who suffered asomnia after using Zicam.
The recall covered both the gel and swab versions of Zicam. In a filing with the Securities and Exchange Commission (SEC), Maatrix said that it intends to vigorously defend each of the recently filed lawsuits. The corporation is barred from marketing the product until it proves to the FDA that Zicam is safe and effective.
A statement on Zicam's website advises customers with remaining Zicam to either dispose of these two nasal Cold Remedy products [gel or swab], or return them through Zicam for one of our Cold Remedy oral products. The statement noted that [t]he other 17 Zicam-branded products (including our Oral cold remedy ) are all safe and effective and will remain on retailer shelves.
The recalled products are:
Zicam Cold Remedy Nasal Gel
Zicam Cold Remedy Nasal Swabs
Zicam Cold Remedy Swabs, Kids Size, a discontinued product