By Susan Brinkmann, OCDS
The Food and Drug Administration (FDA) is warning consumers to stop using the popular homeopathic cold remedy, Zicam, because of hundreds of reports of people losing their sense of smell after using the product.
According to a report in The New York Times, the FDA received 130 reports from consumers and doctors of patients who lost their sense of smell after using one of Zicam’s nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs.
“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” said Deborah M. Autor, director of compliance in the agency’s drug center. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”
The FDA says their complaints date back to 1999 when Zicam was first introduced by Matrixx Initiatives out of Scottsdale, Arizona. Because Matrixx called Zicam a homeopathic product, it was not required to seek FDA approval before selling it. However, by 2006, Matrixx had paid $12 million to settle 340 lawsuits from users who claimed their sense of smell (known as anosmia) was destroyed by the products. Hundreds more lawsuits have since been filed.
The company insists their product is fine, however.
“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” they said in a recent press release. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”
Matrixx had $101 million in sales last year, of which $40 million came from Zicam products.
The FDA, which does not have the power to demand a recall, sent a warning letter to Matrixx on June 16 stating that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.”
The company has responded by suspending shipments of Zicam and promising to reimburse customers who wanted a refund.
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