The Food and Drug Administration is being taken to task for a failure to include chlorhexidine in its recently announced plan to review the safety of active ingredients in antiseptics used in healthcare.

A group that includes Consumers Union, publishers of Consumer Reports, submitted a comment to the docket for the proposed rule, stating: “We would like to strongly recommend the inclusion of chlorhexidine in this initiative. Chlorhexidine is undergoing a rapidly expanding role in the prevention of hospital acquired infections. Many researchers are advocating the use of chlorhexidine every day on every patient in the ICU. However, we feel both the safety and efficacy of chlorhexidine has not been substantiated. There are significant concerns regarding the developing of antibiotic resistance and the long term effects of expanded chlorhexidine usage on the patient’s and facility’s microbiome.”1-3

The exclusion problem may have arisen because the FDA proposed rule is primarily focused on the effect of antiseptics on healthcare workers, while chlorhexidine is often used to decolonize and eradicate the bacterial flora on patients’ skin. Such practices have been shown to reduce infections with methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens.

However, the advocacy group warned that researchers have found evidence of bacteria developing resistance to chlorhexidine. They cited a study that found patients who were bathed daily with chlorhexidine were more likely to develop central-line bloodstream infections with reduced susceptibility to the skin prep solution.4

In addition, the group cited “significant concerns regarding industry influence and research integrity of chlorhexidine. There have been at least four articles which have compared chlorhexidine plus alcohol to another antiseptic but attributed the increase in efficacy to chlorhexidine alone.3 … Therefore we recommend that chlorhexidine be included in the FDA’s proposed regulation calling for more complete safety and effectiveness data on antiseptics.”

Among those signing off on the comment were Kevin T. Kavanagh, MD, MS, Health Watch USA, Lexington, KY 40509; Lisa McGiffert, Consumers Union Safe Patient Project, Austin, TX; and Jean Rexford, Connecticut Center for Patient Safety, Fairfield, CT.

References

  1. Kavanagh KT, Saman DM, Yu Y. Reply to “Planned Analyses of the REDUCE MRSA Trial”. Antimicrob Agents Chemother 2014 Apr;58(4):2486-2487.
  2. Kavanagh KT, Calderon LE, Saman DM. Viewpoint: A response to “Screening and isolation to control methicillin-resistant Staphylococcus aureus: sense, nonsense, and evidence.” Antimicrob Res Infect Cont 2015;4:4.
  3. Maiwald M, Chan ES. Pitfalls in evidence assessment: the case of chlorhexidine and alcohol in skin antisepsis. J Antimicrob Chemother 2014;69(8):2017-2021.
  4. Suwantarat N, Carroll KC, Tekle T, et al. High prevalence of reduced chlorhexidine susceptibility in organisms causing central line-associated bloodstream infections. Infect Control Hosp Epidemiol 2014;35(9):1183-1186.