Zicam Action Ushers in New Day at FDA
July 6, 2009 in Editorial
We first heard about ZIcam on October 9, 2000. That's when the a PR firm touted a study in the ENT (Ear, Nose & Throat) Journal showing that a zinc nasal gel shortened the duration of the common cold.
At that point zinc lozenges had already established themselves in the marketplace. That's because in the 1980s a stubborn little girl with leukemia wouldn't swallow her zinc tablet. Instead, she sucked on it and her cold symptoms disappeared almost overnight.
This prompted her physicians to investigate whether zinc could be effective against the common cold. Studies since then have produced mixed results--some showing benefit and others showing none.
Fast forward to Zicam. Instead of sucking on a lozenge that some people found nauseating, consumers were offered the possibility of squirting or swabbing zinc gluconate straight into their nostrils.
It wasn't long before people were telling us about this wonderful new cold remedy. But by 2005 we began to hear about the dark side of Zicam.
Some people were complaining that using Zicam in their noses impaired the sense of smell: "My sister used Zicam and immediately lost her sense of smell. Her doctors say she will be lucky to get 30 percent back. After 5 weeks, she has barely any sense of smell. She is a medical practitioner and followed the directions explicitly."
Before too long, there were published reports of people losing their sense of smell following the use of zinc nasal gel (Laryngoscope, Feb. 2006). The manufacturer of Zicam countered that such reports were "completely unfounded and misleading."
Consumer Reports alerted the public in January, 2007: "Studies with animals and case reports suggest that nasal zinc may cause loss of smell, possibly permanent. Last year we [CR] unearthed more than 200 complaints to the Food and Drug Administration about an impaired sense of smell, taste, or both after using zinc nasal products."
Meanwhile, Matrixx Initiatives, Inc., the maker of Zicam, settled a class action lawsuit in 2006 with over 300 people for $12 million. Despite the settlement, the company denied that its product was responsible and instead pointed a finger to cold viruses as the culprit.
Now there is new leadership at the FDA. Commissioner Margaret Hamburg, MD, took decisive action only weeks after being confirmed in her new job. She promised to be a tougher cop: "We've been more aggressive in enforcement actions, where people's health is at risk."
The agency backed this claim up by issuing a caution to consumers to stop using Zicam Cold Remedy Nasal Gel and Swabs. In addition, on June 16, 2009, the FDA sent Matrixx a letter warning that the products pose a serious risk to consumers and demanding that the company correct its violations of FDA rules.
This quick action by the new leadership team at the FDA should bolster confidence in the agency's determination to protect the public health. Transparency and decisive action have been missing from this watchdog agency for far too long. Action on these Zicam nasal products is a welcome first step. |
