FDA Issued Warning About Antiseptic Products. On February 2, 2017, the U.S. Food and Drug Administration (FDA) issued a safety warning for skin antiseptic products containing chlorhexidine gluconate. Serious allergic reactions have been reported with over-the-counter products containing this antiseptic, the FDA warned.
“Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years.” As a result, the FDA is asking manufacturers of products containing chlorhexidine gluconate to add a warning about this risk to the drug facts labels.
Chlorhexidine gluconate is available in a variety of over-the-counter products used to clean and prepare the skin before surgery and before injections. Such antiseptics reduce the risk for skin infections. The products are available as solutions, washes, sponges, and swabs and 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. These antiseptics are also sold as generic products, including through store brands. (Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease. These products already contain a warning about the possibility of serious allergic reactions.)
The attorneys at Parker Waichman are well informed about serious allergic reactions, including anaphylaxis, and can answer questions from individuals who have experienced a life-threatening episode.
Life-Threatening Allergic Reaction
Anaphylaxis is a rare, generalized, potentially life-threatening allergic reaction to a particular substance (allergen), WebMD explains. The reaction typically occurs within seconds or minutes or, more rarely, up to a few hours after exposure to the allergen. Allergens may include such substances as insect venom, foods, medications, vaccines, chemicals or other substances. An anaphylactic reaction may be characterized by itchy, reddish rash (hives); a severe drop in blood pressure; swelling and obstruction of the mouth, nose, and throat; abdominal cramps, nausea and vomiting; diarrhea, and difficulty breathing. Without immediate, appropriate treatment, the condition may rapidly lead to unconsciousness (coma) and life-threatening complications. Patients who experience symptoms of an allergic reaction should stop using the product that contains chlorhexidine gluconate and seek medical attention immediately. If necessary, the individual should call 911 in order to get timely medical attention. The reaction can occur within minutes of exposure.
The FDA identified 52 cases of anaphylaxis related to the use of chlorhexidine gluconate products applied to the skin. From January 1969 to early June 2015, the FDA received reports of 43 cases worldwide. More than half of the 43 cases were reported after 2010, and after the agency’s1998 Public Health Notice. The number includes only voluntary reports made to FDA, so the agency said there are likely additional cases of which it is not aware.
Some of the reported cases required emergency department visits or hospitalizations so the affected individual could receive drug and other medical treatments. The reported allergic reactions resulted in two deaths, the FDA notice said. Eight additional cases of anaphylaxis were published in the medical literature between 1971 and 2015, and one case was identified in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) database between 2004 and 2013.
In 1998, the FDA issued a public health notice warning health care providers about the risk for serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.
In the recent safety communication, the FDA is advising health care providers to ask patients whether they have ever had an allergic reaction to an antiseptic before recommending or prescribing a product containing chlorhexidine gluconate. Health care providers should advise patients to seek immediate medical attention if they experience any symptoms of an allergic reaction when using these products. Health care providers should consider using or recommending alternative antiseptics, such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX), in cases where there is a previous documented or suspected allergy to chlorhexidine gluconate.
The FDA urges health care providers to report adverse events related to the use of products containing chlorhexidine gluconate to MedWatch, the FDA’s safety information and adverse event reporting program. Adverse event reports are critical to the FDA’s ability to assess and respond to this type of risk.
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