WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said Tuesday consumers need to stop using certain Zicam cold and allergy products because they can cause permanent loss of smell.
In a warning letter sent to Matrixx Initiatives Inc., Zicam's maker, the FDA said it "has concluded that these products may pose a serious risk to consumers who use them." The agency, which has recently stepped up its enforcement activities, said the products cannot be marketed unless Matrixx seeks FDA approval to sell the products.
Shares of Matrixx Initiatives Inc. (MTXX), maker of Zicam, dropped 68% to $6.26 in recent trading.
In a statement, Matrixx said it "believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace." However, the company said in a separate statement posted on Zicam's Web site that it would stop shipping the products and would reimbuse customers seeking a refund.
The company said it believes the affected products are safe and do not cause anosmia," or loss of smell. The Zicam intranasal products account for about 40% of the company's net sales, which totaled $111.63 million for the year that ended on March 31. Sales of over-the-counter cold and cough products total about $4 billion annually.
Zicam is sold over-the-counter, primarily as a cold and allergy remedy. The products are sold in various forms including intranasal products meant to be used in the nose.
The FDA said consumers should stop using the intranasal zinc-containing products, which are sold as Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs. The agency also said consumers should also stop using Zicam Cold Remedy Swabs, Kids Size, which the company is no longer selling. Agency officials said consumers could still have the children's-size product in their medicine cabinets.
The action doesn't affect other Zicam products, such as tablets, "rapid melts" and liquid forms.
FDA officials said they've received more than 130 reports from consumers about the loss of smell, but said they believe that Matrixx has received about 800 such reports, which have not all been reported to the agency. The FDA said the reports showed that many people who experienced a loss of smell said the condition occurred with the first dose while others reported a loss of the sense of smell after multiple uses of the products. The agency said the loss of smell can be long-lasting or permanent.
In 2006, Matrixx settled more than 300 lawsuits brought by consumers who alleged that Zicam zinc nasal gel damaged or destroyed their sense of smell.
Maxtrixx wasn't required to submit adverse events to the FDA until the end of 2007 when a law went into effect requiring over-the-counter supplement makers to report side effects to the FDA, an agency spokeswoman said.