Four premature babies died and 29 suffered chemical burns, skin loss, rashes, and other “serious side effects” in the U.S. and U.K. after being wiped down with 2% chlorhexidine before a catheter was inserted, according to a health warning in Europe in 2014.
They urged doctors to be cautious when using the antiseptic wipes on premature babies under 32 weeks’ gestational age. No warnings were issued by the U.S. Food and Drug Administration (FDA).
However, on February 2, 2017, the FDA did issue a Safety Alert about a rapidly-growing number of reports of anaphylaxis and “serious allergic reactions” to chlorhexidine gluconate (CHG).
Over 80% of the reports were filed after 2010. The FDA did not say why reports increased so dramatically since 1969, but the evidence points to the growing popularity of hospitals bathing critically ill patients and premature babies with 2% CGH washcloths every day.
Dr. Daniel J. Livorsi explained to Medscape that hospitals are trying to prevent infections, but daily CHG bathing has “uncertain benefits” and was “spurred by several quasi-experimental studies.”
One questionable study was published by the New England Journal of Medicine in 2013. It was partially funded by Sage Products, which sells the most popular 2% CHG cloth on the market.
The conclusions of that study were directly contradicted by a far more scientifically-rigorous study at Vanderbilt Medical Center in 2015. The study found no difference in the rate of infections in ICU patients who were bathed with 2% CHG vs. non-antiseptic cloths.
Dr. Arthur Wheeler explained that older studies supporting the practice are not well-supported:
“This is a practice that is going on all across in the country, not at every single hospital, but at many hospitals; it’s reasonably expensive. The scientific evidence that chlorhexidine cloths make a difference was weak.”
In addition to a lack of evidence that daily 2% CHG baths actually work, paying nurses to bathe patients in antiseptic is a massive use of nursing hours and relatively expensive for the healthcare system.
With little evidence supporting the practice, and concerns about allergic skin reactions and antibiotic-resistance, a growing number of experts are questioning the logic behind the surge in 2% CHG baths.
Source: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate