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FDA Warning: Rare but Serious Allergic Reactions from Skin Antiseptic

On Behalf of | Feb 8, 2017 | FDA Alerts

On February 2, 2017, the Food and Drug Administration (FDA) issued a warning regarding reports of rare but serious allergic reactions on the skin of individuals who have used over-the-counter (OTC) products containing chlorhexidine gluconate. The FDA has requested that manufacturers, which produce antiseptic containing the ingredient, issue a warning detailing the risk on the Drug Facts labels of such products.

What Should Patients and Consumers Know?

Chlorhexidine gluconate can be found in various OTC antiseptic skin products, in addition to mouthwashes and oral products used to combat gum disease. These products are typically used to reduce bacteria that can cause infection, and are available in a variety of forms.

Commonly used products containing the ingredient include Colgate Peroxyl Mouth Sore Rinse, Orajel Antiseptic Rinse and Listerine Ultra Clean Mouthwash, among skin products branded under the names Bioscrub, ChloraPrep and Prevantics. While the allergic reaction—anaphylaxis—caused by the ingredient is rare, it is very serious and potentially fatal if untreated. Patients who experience symptoms of the reaction should immediately seek medical attention. These symptoms include:

  • Wheezing or difficulty breathing
  • Swelling of the face
  • Hives
  • Severe rash
  • Shock

How Common is the Reaction?

The FDA has identified only 52 cases of confirmed anaphylaxis caused by chlorhexidine gluconate products applied to the skin. However, the Administration notes that more than half of these cases were reported after 2010, and that there are likely cases that have gone unreported.

What Patients Should Keep in Mind:

If you have suffered a severe allergic reaction after using a product containing chlorhexidine gluconate, it is important that you or your health care provider report this incident and the related product to the FDA.

For additional information related to product liability alerts and FDA safety warnings, contact the product liability attorneys at The Law Offices of Peter Angelos.