Safety Alerts & Recalls
What does this mean?
If you use any skin cleanser or mouthwash/oral chips product that contains chlorhexidine gluconate, please be aware that these products have the risk of rare but serious allergic reactions.
If you experience symptoms of a serious allergic reaction while using these products, you should stop using the product right away and seek medical attention immediately or call 911. These reactions can occur within minutes of exposure. Symptoms include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow.
Talk to your healthcare provider if you have questions or concerns about this safety alert or any of your medicines.
FDA Warns about Rare but Serious Allergic Reactions with Chlorhexidine Gluconate
The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin cleanser products containing chlorhexidine gluconate. Chlorhexidine gluconate is a widely used antiseptic. It is mainly available in over-the-counter (OTC) products used to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections.
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 (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.
The following products contain chlorhexidine gluconate: --- OTC products are available as topical solutions, washes, sponges, and swabs. They are marketed under brand names such as Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Pharmaseal Scrub Care, and Prevantics. They are also sold as generic products, including store brands.
--- Prescription oral rinse solution to treat gingivitis. It is marketed under the brand name Peridex as well as many generic brands such as Periogard, Oris, PerioRx, and Paroex.
--- Prescription oral chip under the brand name Periochip, which is inserted between the gums and teeth to treat periodontal disease.
--- Some medical devices such as dressings and intravenous lines also contain chlorhexidine gluconate.
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