FDA is warning about rare but serious allergic reactions to widely-used skin antiseptic products containing chlorhexidine gluconate.
“Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years,” FDA said in a recent Drug Safety Communication. “As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts Label.”
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In addition, healthcare professionals should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product, FDA said.
The over-the-counter antiseptics in question include the brand names Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Pharmaseal Scrub Care, and Prevantics. They are also sold as generic products, including through store brands.
Plus, chlorhexidine gluconate is also available as a prescription oral chip under the brand name Periochip, which is inserted between the gums and teeth to treat periodontal disease, according to FDA. 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.
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FDA identified 52 cases of anaphylaxis with the use of chlorhexidine gluconate products applied to the skin. In the 46 years between January, 1969 and early June, 2015, FDA received reports of 43 cases worldwide, and 2 of the cases resulted in death. More than half of the 43 cases were reported after 2010, and after its 1998 Public Health Notice.
“This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware,” FDA said.
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.
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