The FDA warned consumers that Zicam, a cold remedy nasal product, could permanently damage or destroy the user’s sense of smell. Since 1999, the FDA has had over 180 reports of Zicam users who lost their sense of smell. Although the FDA took no action against the manufacturer, Matrixx Initiatives, during the Bush administration, new agency head Dr. Margaret Hamburg ordered the warning signaling the Obama administration’s more proactive stance in drug safety. She said the number of reported cases of anosmia or loss of smell indicated the problem was fairly large.
Zicam is considered a homeopathic medication and not subject to actual recall or pre-market approval under Bush-era rules. New bills currently in Congress would give the FDA that authority. The Bush administration generally relied on “voluntary” action by drug manufacturers after protracted negotiations.
The new FDA warning letter used language typically describing a recall alert. It stated that Zicam Cold Remedy may pose serious risk to consumers in addition to being misbranded. What’s ironic about the whole thing is this: the products have no proven benefit. Consumers beware!
Richard J. Arsenault, 2011
