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FDA: Some antiseptics may cause serious allergic reactions :

February 2, 2017

Common skin antiseptic products have been linked to rare but serious allergic reactions, according to a new warning from the Food and Drug Administration (FDA).

The FDA is advising health care providers and consumers to use care with antiseptic products containing chlorhexidine gluconate and is asking manufacturers to add a warning to the label of over-the-counter products.

Chlorhexidine gluconate often is used to clean skin before surgery or injections and is available as solutions, washes, sponges and swabs, according to the warning.

The FDA identified 52 cases of anaphylaxis worldwide that were tied to use of the product on the skin between January 1969 and June 2015, according to a data summary. Cases have increased in recent years.

Several oral products already contain warning labels about the possibility of allergic reactions, and in 1998 the FDA issued a health notice about medical devices containing chlorhexidine gluconate.

Health care providers should ask patients about allergies to antiseptics before recommending these products, and patients who use them should seek medical attention immediately if they experience an allergic reaction. Symptoms include wheezing or difficulty breathing, swelling of the face, hives, severe rash or shock.

When previous allergy to chlorhexidine gluconate is documented or suspected, alternative antiseptics, including povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride or parachlorometaxylenol, may be used.

Health care professionals and patients can report adverse side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.

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