Federal health officials say more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, doctor’s offices and nursing homes to kill germs and prevent infections.
The Food and Drug Administration is asking manufacturers to submit additional data about medical hand washes and sanitizers, including the long-term effects of their daily use on the skin.
Under a proposed rule, companies must submit new studies looking at key safety issues, including possible hormonal effects and contributions to antibiotic-resistant bacteria. Products that are not shown to be safe and effective by 2018 would have to be reformulated or removed from the market.
For now, the FDA stressed that health-care workers should continue using hand washes, sanitizers and surgical scrubs, which are standard tools for preventing infections. “We’re not asking for any of these products to come off the market at this time; we’re just asking for additional data,” Theresa Michele, a director in the agency’s drug center, said. “And we’re likewise not suggesting that people stop using these products.”
The antiseptic ingredients at issue, including alcohol and iodine, have been used by doctors and nurses for decades. But FDA scientists say their routine use has increased over the last 20 years as health-care workers ramp up efforts to fight hospital infections. Widely adopted professional guidelines currently urge doctors and nurses to sanitize their hands before and after visiting each patient’s room.
“Twenty years ago you didn’t find people using antiseptic gels 100 times a day; it just didn’t happen,” Michele said.
Regulators are also concerned about emerging science suggesting that antiseptics are absorbed into the body at higher levels than previously thought, showing up in the blood and urine of users. “We now understand that many of these ingredients that we thought are just put on the skin are actually systemically absorbed,” Michele said.
The FDA wants companies to provide data from both human and animal studies on absorption rates, blood levels, toxicology and possible links to cancer and hormonal problems. Regulators say they will use this information to determine safety thresholds for users, particularly such vulnerable groups as pregnant women and breast-feeding health care workers.
The FDA will also seek information about possible links between the use of antiseptics and the growth of what are called “superbug” bacteria, which are resistant to antibiotics. Despite these unresolved questions, the agency said in a statement that its actions “should not be taken to mean the FDA believes that these products are ineffective or unsafe.”
Environmentalists have raised concerns about an ingredient called triclosan, which is used in most antibacterial soaps marketed to consumers. Some scientists worry that triclosan and a related chemical, triclocarban, can interfere with hormone levels and spur the growth of drug-resistant bacteria. The agency issued a separate review of triclosan-containing consumer products in late 2013, saying more data is needed to establish their safety and effectiveness.
The ingredient is found in some health-care hand washes and cleaners but is far less common than such ingredients as alcohol and chloroxylenol, according to FDA officials. Those chemicals are sold to hospitals in hand sanitizers, surgical scrubs and other formulations that can be used without water.
The American Cleaning Institute, a trade organization, said it agreed with the FDA’s recommendation that health-care workers continue using antiseptic products. “While manufacturers have submitted extensive data already, we will continue working with the FDA and provide the necessary information to answer their questions,” the group said in a statement.