Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.
On February 2, 2017, the FDA announced it is warning that rare but serious allergic reactions have been reported with the 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. As a result, we are requesting the manufacturers of over-the-counter (or 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.
Health care professionals should ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product. Advise patients to seek immediate medical attention if they experience allergic reaction symptoms. Consider using alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX) when any previous allergy to chlorhexidine gluconate is documented or suspected.
In 1998, we issued a Public Health Notice warning health care professionals about the risk of serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.
We identified 52 cases of anaphylaxis, with the use of chlorhexidine gluconate products applied to the skin. Between January 1969 and early June 2015, FDA received reports of 43 cases worldwide. More than half 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 serious allergic reaction cases reported outcomes that required emergency department visits or hospitalizations for medical treatment. These allergic reactions resulted in two deaths. Eight additional cases of anaphylaxis were published in the medical literature between 1971 and 2015, and one case was identified in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 2004 and 2013.
Side effects involving chlorhexidine gluconate should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing information for health care professionals and the Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at [email protected].
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