FDA Finally Bans Zicam For Serious Adverse Side Effects
By Robert Latkany, MDEdited by Sarah Varney
June 19, 2009
The nose knows. This week, Matrixx Initiatives, makers of Zicam was issued a warning letter from the FDA about the cold remedy. Both Zicam Cold Remedy nasal gel and nasal swabs are now banned from being marketed without approval by the FDA because of possible serious adverse events like the loss of the sense of smell, or anosmia. But something stinks when it comes to the timing of the warning letter.
While FDA’s demand was formalized June 16th, 2009, a report by Jafek et al released almost 5 years ago found that zinc nasal products were toxic to the lining of the inner nose and could lead to anosmia. A retrospective review in 2006 by Alexander and colleague recorded 17 patients who developed anosmia within 48 hours of using intranasal zinc gluconate gel. Eby and colleague conducted a double blind placebo controlled clinical trial comparing zinc nasal sprays and lozenges to placebo and concluded it
was “unethical” to use nasal zinc for temporary colds due to its potential for causing a loss of smell. This same 2006 study also found that zinc did not reduce the severity or duration of the common cold.
So, why did it take FDA so long to put a ban on Zicam? Three years is a long time.
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