FDA: Serious allergic reactions associated with chlorhexidine gluconate

The FDA issued a safety announcement regarding serious allergic reactions reported with the use of skin antiseptic products containing chlorhexidine gluconate. These reactions are rare, but the reports have increased over the last few years.

Chlorhexidine gluconate is found in a number of over-the-counter products used to clean and prepare the skin before surgery and before injections. Between January 1969 and June 2015, the FDA received reports of 43 cases of anaphylaxis with the use of chlorhexidine gluconate products worldwide. More than half of the 43 cases were reported after 2010. The FDA issued a public health notice regarding the use of chlorhexidine gluconate products in 1998.

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The latest safety announcement requests that manufacturers of chlorhexidine gluconate-based antiseptics add a warning about the risk of allergic reaction to the Drug Facts labels.

Additionally, the FDA noted that healthcare professionals should "should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product."

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