Zicam is has caused side effects in patients and the Food and Drug Administration (FDA) has advised the public to stop using them.
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (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)
The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “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.”
Source: FDA
Matrixx reports that it sold 35 million retail units of the products in question which equals about 1 billion doses. Of these, the FDA is focusing on 130 reports of problems. The percentage of people experiencing side effects, based on units sold is .0000037 percent — or .0000265 percent if you figure in the 800 “unreported” cases. It would even be more miniscule if it were calculated on the number of doses.
Can FDA approved drugs claim this extremely low incidence of side effects?
As a concerned consumer who likes to be informed, I sat in on the Matrixx conference call today. One reporter who has been covering this industry for 12 years noted that the FDA’s action was unprecendented and uncharacteristic. I also learned that Matrixx conducted 4 peer reviewed clinical studies in 2004 that showed no causal relationship between Zicam products and smell loss – something that has been rarely reported in coverage of this story. What IS known to cause smell loss is 1) the common cold, 2) sinusitis, 3) nasal injury. Aging also contributes to smell loss, just as our other senses become less sharp as we age.
BTW – I do not work for Matrixx. I just like being fully informed about a product and a precedent that could have far reaching effects. Surely there should be a warning on the package insert about the possibility of anosmia – but the product should not be banned because some people have experienced problems. If so, what about peanuts, chocolate, shellfish, gluten and other food substances that have caused serious consequences or even death, and in much greater numbers than what is being reported for the Zicam products?