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Matrixx Initiatives Pulls Zicam Products

Company disputes FDA warning about nasal remedies

June 18, 2009

“Consumer safety is and has always been the company's top priority,” the company said in a statement. “While Matrixx Initiatives believes that the FDA action today was unwarranted, it is voluntarily withdrawing Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market. Based on the FDA's recommendation, consumers should discard any unused product or contact Zicam at 1-877-942-2626 or visit www.zicam.com to request a refund.”

The FDA said it had logged more than 130 complaints from consumers detailing their loss of the sense of smell after using the nasal products. It urged consumers to stop using three Zicam products because they are associated with the loss of sense of smell, a condition known as anosmia. Anosmia may be long-lasting or permanent.

The products are:

• Zicam Cold Remedy Nasal Gel

• Zicam Cold Remedy Nasal Swabs

• Zicam Cold Remedy Swabs, Kids Size, a discontinued product

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

But the company, while withdrawing the products, has done so under protest.

"Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its Zicam Cold Remedy intranasal gel products and anosmia," said William J. Hemelt, Matrixx Initiatives' acting president. "It is well understood in the medical and scientific communities that the most common cause of anosmia is the common cold, which Zicam Cold Remedy intranasal gel products are taken to treat. Given the enormous number of doses sold and colds treated, there is no reason to believe the number of complaints of anosmia received is more than the number that would be expected in the general population. There is no reliable scientific evidence that Zicam causes anosmia."

Hemelt the company was taken by surprise by the FDA warning, since the action was taken without notifying Matrixx Initiatives first.

“Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products." Hemelt said.

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