FDA identified at least 52 cases of anaphylaxis, a severe form of allergic reaction, associated with the use of chlorhexidine gluconate when applied to the skin. From January 1969 to June 2015, the agency received 43 reports of anaphylaxis in patients who used chlorhexidine gluconate worldwide.
These allergic reactions resulted in at least two deaths, according to the FDA.
More than half the 43 cases were reported after 2010, and this number only includes reports submitted to FDA, so there are likely many more cases about which the agency is unaware. The reported anaphylaxis cases required emergency room visits or hospitalization for treatment.
As a result of these problems, FDA is requiring manufacturers of over-the-counter (OTC) chlorhexidine gluconate antiseptics to include a warning about this risk in their Drug Facts labels.
Symptoms of anaphylaxis include wheezing or difficulty breathing, swelling of the face, and hives that can quickly progress to more serious symptoms such as severe rash or shock, which is a potentially fatal condition that occurs when the body is not getting enough blood flow.
Chlorhexidine gluconate is widely available in OTC products to clean and prepare the skin before surgery, and before injections in order to help reduce bacteria that can cause infections. These products are sold under many different brand names, including:
- Biopatch wChlorhexidine Gluconate
- Operand Chg Surgical Scrub Brush
- Operand Chlorhexidine Gluconate
- Operand Closed Loop Chg Scrub
Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease. In 1998, FDA issued a Public Health Notice warning healthcare professionals about the risk of serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.