Zinc-Containing Intranasal Products Recalled
The Food and Drug Administration asked the manufacturer of Zicam intranasal sprays and gels that contain zinc to recall those products and advised consumers to immediately stop using them because of the potential for anosmia.
In a warning letter sent to Matrixx Initiatives, the FDA's Center for Drug Evaluation and Research said that it has directly received from consumers and health care providers more than 130 reports of anosmia associated with use of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. In addition, the agency said in a warning letter sent to the company that it “is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products.”
Loss of the sense of smell has been permanent in some cases. In addition, many people who experienced anosmia said it occurred with the first dose, according to the FDA.
In a briefing with reporters, Deborah M. Autor, director of CDER's Office of Compliance, said that the agency was taking action because anosmia had the potential to be life-threatening—for instance, if someone was not able to smell a gas leak or something burning—and that it could severely affect quality of life. Also, the number of adverse event reports were very high for an over-the-counter product, Ms. Autor said. The FDA discovered the additional 800 adverse event reports during an inspection of Matrixx earlier this year, according to the agency.
“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” Ms. Autor said.
The Zicam cold remedy products are Matrixx's top-sellers, grossing $79 million in the fiscal year that ended March 31. For the last few years, cold remedy product sales have increased about 70% annually. The original product, the Zicam Cold Remedy nasal pump, was introduced in 1999.
The cold remedy products were in somewhat of a murky regulatory area, however. They are homeopathic, containing an active ingredient—zincum gluconicum 2X—that is measured in homeopathic strength, the agency said. In its letter, the FDA acknowledged that many homeopathic products are marketed without the agency's approval.
In the case of Zicam, the products claim to shorten the duration of a cold and thus are being marketed as drugs. Therefore, Matrixx is required to seek formal approval from the agency, Ms. Autor said.
Matrixx has conducted some small safety and effectiveness studies with the zinc-containing products, but none were large enough to detect any serious side effects, she said.
A recently published meta-analysis by New Zealand researchers found that there may be some benefit from zinc-containing nasal products for adults with the common cold (J. Primary Health Care 2009;1:134-9). The authors concluded, however, that the frequency of anosmia should be established before zinc sprays or gels were widely recommended.
Matrixx has been hounded for years by reports that Zicam has led to anosmia. A Google search turns up numerous links to personal injury attorneys fishing for clients. In 2006, Matrixx settled more than 340 suits claiming that its zinc-containing products led to a loss of sense of smell. The company admitted no liability.
Dr. Charles E. Lee, a medical officer at the FDA's Division of New Drugs and Labeling Compliance, said the agency is aware of animal studies and historical reports in the medical literature linking zinc salts to anosmia.
Matrixx was required to come up with a plan to remove the Zicam products from the marketplace within 15 days of the agency's June 16 warning letter.
