FDA: Chlorhexidine Gluconate May Cause Allergic Reactions

Megan Brooks

February 02, 2017

Serious allergic reactions have been reported with over-the-counter (OTC) skin antiseptic products containing chlorhexidine gluconate, the US Food and Drug Administration (FDA) warned today in a safety communication.

"Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years," the agency said.

As a result, the FDA is asking manufacturers of antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the drug facts labels.

Chlorhexidine gluconate is available in OTC products to clean and prepare the skin before surgery and before injections to reduce the risk for skin infections. These products are available as solutions, washes, sponges, and swabs. They are available under several different brand names and as generics.

The labels for prescription chlorhexidine gluconate mouthwashes and oral chips used for periodontal disease already contain a warning about the possibility of serious allergic reactions. In 1998, the FDA issued a public health notice warning healthcare providers about the risk for serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.

In today's safety communication, the FDA said they know of 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, the agency received reports of 43 cases worldwide through the agency's Adverse Event Reporting System (FAERS). More than half of the 43 cases were reported after 2010, after the 1998 public health notice.

"This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware," the FDA said. "The serious allergic reaction cases reported outcomes that required emergency department visits or hospitalizations to receive drug and other medical treatments. These allergic reactions resulted in two deaths."

The agency said that eight additional cases of anaphylaxis were published in the medical literature between 1971 and 2015 and that one case was identified in the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 2004 and 2013.

The FDA is advising healthcare providers to ask patients whether they have ever had an allergic reaction to any antiseptic before recommending or prescribing a product containing chlorhexidine gluconate. They also say patients should be advised to seek immediate medical attention if they experience any symptoms of an allergic reaction when using these products.

Healthcare providers should also consider using alternative antiseptics, such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX), in cases of any previous documented or suspected allergy to chlorhexidine gluconate, the FDA said.

Healthcare providers are encouraged to report adverse events related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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