Pharmacy Services Alerts
Chlorhexidine Gluconate – Anaphylaxis Warning Added to Over-the-Counter Drug Facts Label
Feb 10, 2017 10:00 AM
Chlorhexidine gluconate is an ingredient in prescription oral treatments (eg, mouthwash, periodontal chips) and many over-the-counter (OTC) disinfectants used for sterilization prior to injection or surgery. Chlorhexidine gluconate is available OTC as a topical solution, wash, sponge, or swab. Brand names include Prevantics, Pharmaseal Scrub Care, Hibistat, Hibiclens, Exidine, Dyna-Hex, CIDA-Stat, ChloraPrep, CHG Scrub, Brian Care, Bioscrub, and Avagard.
In 1998 the FDA issued a warning about serious allergic reactions to chlorhexidine gluconate, which was added to labeling for prescription products. There have been 52 documented cases of anaphylaxis associated with topical chlorhexidine gluconate reported through the FDA Adverse Event Reporting System, the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance database, and published literature. Two of the events resulted in death. Due to increases in reports of anaphylaxis, a warning is now being added to the OTC Drug Facts labels.
Inform patients of the risk of hypersensitivity and anaphylaxis. Obtain allergy information in regards to topical disinfectants, prescription mouthwashes, or medical devices sterilized with chlorhexidine gluconate. If a documented hypersensitivity exists, or is suspected, use an alternative such as povidone-iodine, an alcohol, benzalkonium chloride, parachlorometaxylenol, or benzethonium chloride. If a hypersensitivity occurs prior to receiving an injection or undergoing a surgical procedure verify if chlorhexidine gluconate was used and consider it as a possible cause. Instruct patients to call 911 and remove the product in the event of any of hypersensitivity (eg, difficulty breathing, swelling of the face). Report events of hypersensitivity/anaphylaxis to the FDA MedWatch Reporting Program.
Additional information is available at the links below:
- FDA Drug Safety Communication – February 2, 2017