Skin Antiseptic Chlorhexidine: Defense against Infection Comes with Risk

Chlorhexidine is a disinfectant and topical anti-infective agent with a novel mechanism of action that makes it highly unlikely that microbes will develop resistance to it. Its unique antimicrobial capabilities make chlorhexidine an important line of defense against nosocomial infections. Unfortunately, chlorhexidine use can be dangerous.

According to the National Center for Biotechnology Information’s PubChem database entry for chlorhexidine, chlorhexidine is a disinfectant and topical anti-infective agent used as a surgical hand scrub; skin wound and general skin cleanser; health care personnel hand wash; and for preoperative skin preparation. It is also used as mouthwash to prevent oral plaque. Chlorhexidine gluconate (a commonly used salt form of chlorhexidine) is the active ingredient in five prescription products approved by the FDA and 19 FDA approved over-the-counter (OTC) products. These products are available as solutions, washes, sponges, and swabs and under many different brand names, as well as generics.

Chlorhexidine’s novel mechanism of action makes it highly unlikely that microbes will develop resistance to it. Chlorhexidine is positively charged and reacts with the negatively charged microbial cell surface, thereby destroying the integrity of the cell membrane. Subsequently, chlorhexidine penetrates into the cell and causes leakage of intracellular components leading to cell death.

Chlorhexidine is an important line of defense against nosocomial infections. As noted in the Scalpel Weekly News, October 10, 2016, “37,000 Deadly Bloodstream Infections Related to Dialysis,” the CDC announced it was teaming up with a broad coalition of kidney and dialysis organizations to reduce the number of bloodstream infections in dialysis patients. Each year, about 37,000 people get potentially deadly bloodstream infections related to their dialysis treatment. One of the interventions promoted in this effort was using an alcohol-based chlorhexidine (>0.5%) solution as the first line skin antiseptic agent for central line insertion and during dressing changes.

Chlorhexidine’s unique antimicrobial capability was highlighted in a February 2017 study published by the CDC, as noted in the Scalpel Weekly News, February 13, 2017, “Hospital-Acquired Yeast Pathogen Not Controlled by Antifungals; Biofilm Concern.” Researchers investigated the susceptibility of a highly virulent, multidrug-resistant fungus, Candida auris, which has been associated globally with life-threatening invasive nosocomial diseases, such as bloodstream and wound infections, to a panel of antifungal agents and chlorhexidine. Researchers performed antifungal susceptibility testing using fluconazole, voriconazole, caspofungin, micafungin, liposomal amphotericin B, amphotericin B, and chlorhexidine. The antifungal agents ability to inhibit C. auris ranged from entirely ineffective against planktonic cells, single cells that may float or swim in a liquid medium, and sessile cells, yeast cells immobilized in biofilm, to effective against only planktonic cells at high concentrations. The researchers noted that chlorhexidine exhibited the greatest activity, requiring a less than 0.02% concentration to effectively inhibit planktonic and sessile cells across all strains tested. The researchers concluded that C. auris in hospital environments was not likely to be controlled with standard antifungal approaches. However, the report showed that chlorhexidine was effective against C. auris planktonic and sessile communities. Thus, researchers recommended the use of chlorhexidine for topical control of C. auris at standard concentrations used for skin and wound cleansing and disinfection (0.05%–4.0%).

Unfortunately, using this extremely effective antimicrobial comes with serious risks. On February 2, 2017, the FDA warned that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate, as noted in the Scalpel Weekly News, February 13, 2017, “Rare but Serious Allergic Reaction to Skin Antiseptic.” Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. 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. As a result, the FDA asked the manufacturers of OTC antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels.

By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.

For more details about the CDC’s announcement regarding reducing bloodstream infections in dialysis patients, see the Scalpel Weekly News, October 10, 2016, “37,000 Deadly Bloodstream Infections Related to Dialysis.”

For more details about the CDC report on C. auris, see the Scalpel Weekly News, February 13, 2017, “Hospital-Acquired Yeast Pathogen Not Controlled by Antifungals; Biofilm Concern.”

For more details about the FDA safety alert, see the Scalpel Weekly News, February 13, 2017, “Rare but Serious Allergic Reaction to Skin Antiseptic.”

See also Medical Law Perspectives, June 2016 Report: How Risky Is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections

See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment 

See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who is Liable and Why?

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