Rare but serious allergic reactions have surfaced associated with the use of popular skin antiseptic products that contain chlorhexidine gluconate. The U.S. Food and Drug Administration (FDA) received reports of hospitalization and death related to severe adverse effects involving these products.
Uses for Chlorhexidine Gluconate
Chlorhexidine gluconate is in a germicidal mouthwash that may be used to reduce bacteria in the mouth and belongs to a class of drugs known as antimicrobials. An oral rinse containing chlorhexidine gluconate can be used to treat gingivitis (swelling, redness, bleeding gums), and is usually prescribed by a dentist.
Chlorhexidine gluconate oral rinse is not for treating every type pf gingivitis. It is to be used only to treat the condition a dentist prescribes it for. This medication should not be shared with another person, even if they have the same gum symptoms. Chlorhexidine gluconate should not be given to a child or teenager without a doctor’s advice. This medication may cause severe irritation or chemical burns in young children.
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Chlorhexidine has also been used in those with weakened immune systems to decrease the formation of mouth sores (mucositis), and used to help prevent pneumonia in hospitalized patients breathing through a ventilator, according to WebMD.
Chlorhexidine gluconate will not treat a viral fungal infection such as cold sores, canker sores, or oral thrush, which is a yeast infection.
To reduce infection, use when topical antiseptic is used, and to minimize risks of these products becoming contaminated with bacteria during use, the FDA asks those manufacturers that package antiseptics indicated for pre-operative or pre-injection skin preparation to ensure the products are packaged in single-use containers.
Allergic Reactions Involving Chlorhexidine Gluconate
A severe form of allergic reaction called anaphylaxis was identified in 52 cases where chlorhexidine gluconate products had been applied to the skin. Between January 1969 and June 2015, the agency received reports of 43 cases worldwide. Over half of the 43 cases were reported after 2010, and after a 1998 Public Health Notice. There are likely additional incidents about which the agency has no knowledge, as the number only includes reports submitted to the FDA.
The number of reports of severe allergic reactions to these products has increased over the last few years. Due to these reactions, the FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to put a warning about these risks on the Drug Fact labels.
Some allergic reactions that are more serious required emergency department visits or hospitalizations to receive medical treatment. These severe allergic reactions reported resulted in two deaths. Eight additional anaphylaxis cases were published in the medical journals between 1971 and 2015. Several of these cases were identified in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 2004 and 2013.
Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the potential of serious allergic reactions in their labels.
The FDA notes that symptoms of a serious allergic reaction include: difficulty breathing or wheezing; swelling of the face that may rapidly progress to more serious symptoms; severe rash; or shock, a life-threatening condition that occurs when the body does not get sufficient blood flow.
Emergency medical help may be necessary if the following signs appear: hives; swelling of the face, lips, tongue, or throat; white patches or sores inside the mouth or on the lips; mouth ulcers or swelling of the salivary glands (underneath the jaw). Less serious side effects may include: mouth irritation; dry mouth; unusual or unpleasant taste in the mouth; or decreased taste sensation.
Chlorhexidine gluconate is mostly available in OTC products to clean and prepare the skin before surgery and before injections to help reduce bacteria that may potentially cause skin infections. These products are available as solutions, washes, sponges, and swabs and under many various brand names and as generics.
In 1998, the FDA issued a Public Health Notice to warn health care professionals about the risk of serious allergic reaction with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate. To reduce risk of allergic reactions, health care professionals and patients should follow product label directions carefully, advises the FDA.
Legal Information and Advice
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