Chlorhexidine gluconate often is used to clean skin before surgery or injections and
is available as solutions, washes, sponges and swabs, according to the warning.
The FDA identified 52 cases of anaphylaxis worldwide that were tied to use of the
product on the skin between January 1969 and June 2015, according to a data summary. Cases have increased in recent years.
Several oral products already contain warning labels about the possibility of allergic
reactions, and in 1998 the FDA issued a health notice about medical devices containing
Health care providers should ask patients about allergies to antiseptics before recommending
these products, and patients who use them should seek medical attention immediately
if they experience an allergic reaction. Symptoms include wheezing or difficulty breathing,
swelling of the face, hives, severe rash or shock.
When previous allergy to chlorhexidine gluconate is documented or suspected, alternative
antiseptics, including povidone-iodine, alcohols, benzalkonium chloride, benzethonium
chloride or parachlorometaxylenol, may be used.
Health care professionals and patients can report adverse side effects to the FDA’s
MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.