Is Zicam Risk Worth the Benefit?

Columbus, OHIt's a scenario that occurs in many households across the US: a person feels a cold coming on and reaches for the cold medication. In some cases, the cold medication that is reached for is Zicam. However, in many cases the cold sufferer assumes the side effects will include fatigue, headache or nausea, at worst. She does not assume that by using a cold product she is risking suffering Zicam smell loss. And that has reportedly happened to some people who experience Zicam side effects.

The FDA received approximately 130 reports of patients suffering anosmia (a loss of the sense of smell) after using Zicam products. This may not sound like a huge concern, given the millions of people who use Zicam to treat their cold symptoms. However, consider that many people may have simply assumed their loss of smell had to do with other factors—the cold itself or a nerve condition, perhaps. Many people may have lost their sense of smell and had no idea until after the news about Zicam broke that it had anything to do with their condition.

"Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock from the FDA in a news release. "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."

In a letter to the company requesting that certain Zicam products be taken off the market, the FDA wrote, "FDA has concluded that these products may pose a serious risk to consumers who use them." Furthermore, "We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling."

Zicam Warnings Too Late?

Despite the FDA's warning, some say that Matrixx Initiatives, maker of Zicam, knew a few years ago about the link between anosmia and Zicam. According to reports, Matrixx paid $12 million to settle a class action lawsuit involving approximately 300 plaintiffs, who alleged that Zicam was the cause of their loss of sense of smell.

In spite of that lawsuit, Matrixx continued to market Zicam. It pulled the affected Zicam products off store shelves at the FDA's request, in June, 2009, but has also issued a statement asserting that Zicam is safe to use.