Rare but life-threatening risk with chlorhexidine gluconate products.
by John Gever
Managing Editor, MedPage Today February 02, 2017
WASHINGTON — Antiseptic solutions, washes, sponges, and other products containing chlorhexidine gluconate may carry a slight risk of causing severe allergic reactions including anaphylaxis, the FDA said Thursday.
The agency said it had identified 52 cases of anaphylaxis in individuals worldwide in the past 70 years who had used chlorhexidine gluconate products, including two fatalities. About half of these occurred since 2010.
These products are sold over the counter under more than a dozen brand names and as generics, and use is widespread, the FDA noted. It emphasized that the risk appears to be rare, but it issued the new warning because reports of such reactions have been increasing.
Nevertheless, the agency urged healthcare professionals to ask patients about previous allergic reactions to skin antiseptics. If allergic potential is suspected, the FDA said, alternatives such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or paracholometaxylenol can be used instead.
In addition to the many OTC products containing chlorhexidine gluconate, the chemical also comes as a prescription mouthwash for gingivitis and as a prescription oral chip for treating periodontal disease. Labels for these products currently include a notice about allergy risk.
Also, some medical devices such as intravenous lines include chlorhexidine gluconate; the FDA warned in 1998 about possible allergic reactions to those products as well.