FDA Warns of Rare but Serious Allergic Reactions Reported with Skin Antiseptic Products Containing Chlorhexidine Gluconate

February 7, 2017

On Thursday, February 2nd, the FDA issued a safety announcement, warning consumers of rare but serious allergic reactions that have occurred with widely used skin antiseptic products containing chlorhexidine gluconate.

What is Chlorhexidine Gluconate?

Chlorhexidine gluconate is a disinfectant and antiseptic that is mainly available in OTC products to clean and prepare the skin before surgery and before injections.  Products containing the substance are used to help reduce bacteria that potentially can cause skin infections.  Chlorhexidine gluconate is present in a number of products that come in a variety of forms, including solutions, washes, sponges, and swabs.  It is included in a variety of different brand name products as well as their generic counterparts.

In addition, the substance is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease.

History with the FDA

Chlorhexidine gluconate was the subject of a Public Health Notice in 1998.  At this time, the FDA warned about the risk of serious allergic reactions associated with the use of medical devices, including dressings and intravenous lines containing the substance.  Furthermore, in FDA’s recent alert, the Agency stated that “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.”

FDA Warning

Over the past several years, the FDA has received numerous reports of serious allergic reactions associated with the use of products containing chlorhexidine gluconate.  Although they are extremely rare, the FDA is “requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts Label.”

In its public notice, the FDA states that it has “identified 52 cases of anaphylaxis, a severe form of allergic reaction, with the use of chlorhexidine gluconate products applied to the skin.”  In the past 46 years, the FDA has received reports of 43 cases worldwide.  Additionally, more than half of these 43 cases have been reported since 2010.  The allergic reactions that have been reported have resulted the death of two people.  Furthermore, FDA also states that there have also been eight additional cases of anaphylaxis published in medical literature between 1971 and 2015.

The FDA notes that “this number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. The serious allergic reaction cases reported outcomes that required emergency department visits or hospitalizations to receive drug and other medical treatments.”

The FDA is advising patients and consumers to stop using products containing chlorhexidine gluconate, and is further recommending that individuals “seek medical attention immediately or call 911 if they experience symptoms of a serious allergic reaction.”  According to the Agency’s statement, these reactions can occur within minutes of being exposed to the substance, and symptoms can include:

  • Wheezing or difficulty breathing
  • Swelling of the face
  • Hives that can quickly progress to more serious symptoms
  • Severe rash
  • Shock, which the Agency states “is a life-threatening condition that occurs when the body is not getting enough blood flow.”

The Agency notes that health care professionals “should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product.”  Additionally, for patients who have experienced a previous allergy to chlorhexidine gluconate, or it is expected, health care professionals should “consider using alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX).”

For additional information on the Agency’s warning, view the FDA Drug Safety Communication.

Our regulatory group specializes in all things pertaining to an FDA submission and can help get your product approved by the Agency in the most time and cost effective manner.  To learn more about our servicescontact us today.

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