Washington, DC: Reports of hospitalization and death prompt the U.S. Food and Drug Administration (FDA) to issue a warning about rare but serious allergic reactions associated with the use of popular skin antiseptic products containing chlorhexidine gluconate.
The FDA identified 52 cases of anaphylaxis, a severe form of allergic reaction, with the use of chlorhexidine gluconate products applied to the skin. In the 46 years between January 1969 and early June 2015, the agency received reports of 43 cases worldwide. More than half of the 43 cases were reported after 2010, and after our 1998 Public Health Notice. This number includes only reports submitted to FDA, so there are likely additional cases about which the agency is unaware.
The serious allergic reaction cases reported outcomes that required emergency department visits or hospitalizations to receive drug and other medical treatments. These allergic reactions resulted in two deaths. Eight additional cases of anaphylaxis were published in the medical literature between 1971 and 2015,1-3 and one case was identified in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 2004 and 2013.
Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, the agency is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels.
Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels.
The FDA advises that symptoms of a serious allergic reaction include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow.
Chlorhexidine gluconate is mainly available in OTC products to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. These products are available as solutions, washes, sponges, and swabs and under many different brand names and as generics (see Facts about Chlorhexidine Gluconate).
Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease. In 1998, the FDA issued a Public Health Notice to warn health care professionals about the risk of serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.