FDA: Life-Threatening Allergic Reactions Linked to Skin Antiseptic

The FDA is requesting that manufacturers of OTC antiseptics containing chlorhexidine gluconate add new warnings
The FDA is requesting that manufacturers of OTC antiseptics containing chlorhexidine gluconate add new warnings

The Food and Drug Administration (FDA) has warned that rare but serious allergic reactions have been reported with skin antiseptics containing chlorhexidine gluconate. The number of reports of these are rare but serious allergic reactions have risen over the last several years.

The FDA is requesting manufacturers of over-the-counter (OTC) antiseptics containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts label. The warning about serious allergic reactions is already incorporated in the labels of prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease. 

Reactions can occur within minutes of exposure presenting as wheezing, difficulty breathing, face swelling, hives, severe rash, or shock. A total of 52 cases of anaphylaxis associated with chlorhexidine gluconate products applied to the skin have been identified. Between January 1969 and early June 2015, the FDA has received 43 case reports worldwide—24 which were reported after 2010. All of the case outcomes were classified as serious with 26 reported as life-threatening, 12 requiring hospitalization, and two deaths due to anaphylactic reaction. In 39 of the 43 cases, hypotension associated with either skin, respiratory, or gastrointestinal (GI) symptoms was reported.  

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Before recommending or prescribing a chlorhexidine gluconate product, healthcare professionals should ask patients if they have ever experienced an allergic reaction to any antiseptic. If any previous allergy to chlorhexidine gluconate is documented or suspected, alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX) should be considered. If a patient experiences an unexplained allergic reaction before or during an injection or surgical procedure, clinicians should check to see whether chlorhexidine gluconate was used.

OTC chlorhexidine gluconate is available as solutions, washes, sponges, and swabs marketed under different brand names (Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Pharmaseal Scrub Care, Prevantics) and generic names. They are used to clean and prepare the skin prior to surgery and injections to reduce bacteria that can cause skin infections. Prescription chlorhexidine gluconate is available as a mouthwash ( Peridex, Periogard, Oris, PerioRx, Paroex) indicated to treat gingivitis and as an oral chip (Periochip) to treat periodontal disease. 

For more information call (855) 543-3784 or visit FDA.gov.

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