FDA News

FDA warns of rare, serious allergic reactions with skin antiseptic chlorhexidine gluconate

The FDA recently issued a warning to patients and health care professionals that rare but serious allergic reactions have been reported with skin antiseptic products containing chlorhexidine gluconate.

The agency reported in a safety announcement that while rare, the number of reports of serious allergic reactions to the products have increased over the past several years.

The agency has requested that manufacturers of the over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate add a warning about the risk to the Drug Facts label, since the number of reports of serious allergic reactions has increased over the last several years, according to a safety announcement from the FDA.

Chlorhexidine gluconate, a widely used antiseptic, is mainly available in OTC products, including solutions, washes, sponges and swabs, to clean and prepare the skin before surgery and before injections to reduce bacteria that have the potential to cause skin infections, according to the release.  Brand names include Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Phamaseal Scrub Care and Prevantics. Chlorhexidine gluconate is also available in generic and store brands, according to the announcement.

Prescription chlorhexidine gluconate mouthwash to treat gingivitis and prescription oral chips to treat periodontal disease already contain on their labels a warning about possible serious allergic reaction, according to the FDA.

“We identified 52 cases of anaphylaxis, a severe form of allergic reaction, with the use of gluconate products applied to the skin” the FDA reported in the safety announcement. “In the 46 years between January 1969 and early June 2015, FDA 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 we are unaware.”

The agency reported that serious allergic reactions cases that required emergency visits or hospitalizations resulted in two deaths.

The agency reports that patients and consumers should stop using a product containing chlorhexidine gluconate and seek medical attention immediately if they experience symptoms of a serious allergic reaction, including wheezing or difficulty breathing, swelling of the face, hives that quickly progress to more serious symptoms, severe rash or shock.

Health care professionals are being advised by the FDA to always ask patients if they have ever had an allergic reaction to antiseptic before recommending or prescribing a product with chlorhexidine gluconate, and to consider using alternative antiseptics including povidone-iodine, alcohol, benzalkonium chloride, benzethonium chloride or parachlorometaxylenol if any previous allergy to chlorhexidine gluconate is suspected.

Reference: www.fda.gov

The FDA recently issued a warning to patients and health care professionals that rare but serious allergic reactions have been reported with skin antiseptic products containing chlorhexidine gluconate.

The agency reported in a safety announcement that while rare, the number of reports of serious allergic reactions to the products have increased over the past several years.

The agency has requested that manufacturers of the over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate add a warning about the risk to the Drug Facts label, since the number of reports of serious allergic reactions has increased over the last several years, according to a safety announcement from the FDA.

Chlorhexidine gluconate, a widely used antiseptic, is mainly available in OTC products, including solutions, washes, sponges and swabs, to clean and prepare the skin before surgery and before injections to reduce bacteria that have the potential to cause skin infections, according to the release.  Brand names include Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Phamaseal Scrub Care and Prevantics. Chlorhexidine gluconate is also available in generic and store brands, according to the announcement.

Prescription chlorhexidine gluconate mouthwash to treat gingivitis and prescription oral chips to treat periodontal disease already contain on their labels a warning about possible serious allergic reaction, according to the FDA.

“We identified 52 cases of anaphylaxis, a severe form of allergic reaction, with the use of gluconate products applied to the skin” the FDA reported in the safety announcement. “In the 46 years between January 1969 and early June 2015, FDA 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 we are unaware.”

The agency reported that serious allergic reactions cases that required emergency visits or hospitalizations resulted in two deaths.

The agency reports that patients and consumers should stop using a product containing chlorhexidine gluconate and seek medical attention immediately if they experience symptoms of a serious allergic reaction, including wheezing or difficulty breathing, swelling of the face, hives that quickly progress to more serious symptoms, severe rash or shock.

Health care professionals are being advised by the FDA to always ask patients if they have ever had an allergic reaction to antiseptic before recommending or prescribing a product with chlorhexidine gluconate, and to consider using alternative antiseptics including povidone-iodine, alcohol, benzalkonium chloride, benzethonium chloride or parachlorometaxylenol if any previous allergy to chlorhexidine gluconate is suspected.

Reference: www.fda.gov