The FDA issued a warning to stop using and discard three zinc-containing Zicam intranasal products, as they may cause anosmia. The FDA, however, does not regulate homeopathic products such as Zicam, leading some to ask if the agency should.
The
warning was issued after the the Food and Drug Administration (FDA) received 130 complains of anosmia (the loss of sense of smell) associated with use of Zicam Cold Remedy Nasal Gel, Remedy Swabs, and Remedy Swabs, Kids Size.
Zicam has been on the market for ten years.
In response, Nasdaq Stock Market composite trading saw shares of maker Matrixx Initiatives (MTXX)
plummet over
70 per cent.
In taking the products listed, the loss of sense of smell, the FDA reports, "may be long-lasting or permanent." The cause of concern is the main ingredient, soluble zinc. Zinc has been "known to be harmful long before it was used in the cold remedy."
FDA has special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.
Many people who experienced a loss of sense of smell say that the condition occurred with the first dose, although some people have reported loss of sense of smell after later doses. FDA is concerned that the loss of sense of smell may be permanent. - FDA
Currently, homeopathic drug products are allowed to be sold without FDA approval or warning labels. According to the
National Institutes of Health, homeopathy is based on “giving extremely small doses of substances that produce characteristic symptoms of illness in healthy people when given in larger doses.”
Some bloggers and columnists believe that "a voluntary Zicam recall would not occur due to the company learning that the product causes anosmia in users, but because of fear of profit losses resulting from lawsuits."
Others, however, have expressed concern over the growing scope of the FDA.
The Wall Street Journal notes the following:
As the FDA’s warning letter makes clear, “many homeopathic drug products are manufactured and distributed without FDA approval.” But, the letter adds, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers. That’s what it’s doing in this case.
Matrixx has called the FDA action “unwarranted." Its statement is available
online.
