The Food and Drug Administration (FDA) is collecting information about the safety and effectiveness of hand sanitizers used by hospital workers dozens of times each day.
Under a proposed rule published last week, companies must submit new studies of key safety issues, including possible hormonal effects and the sanitizers’ contribution to the development of 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, according to The Associated Press (AP).
The FDA estimates that it could cost companies between $64 and 90 million to conduct the requested studies. For now, the FDA advises health care professionals to continue using hand washes, sanitizers, and surgical scrubs. The products are major tools for preventing the spread of infection in health care settings. Dr. Theresa Michele, director of the FDA’s Center for Drug Evaluation and Research, told the AP, “We’re not asking for any of these products to come off the market at this time.”
Doctors and nurses have used alcohol and iodine for hand sanitizing for decades, but routine use of antiseptics has increased over the past 20 years as hospitals step up their efforts to fight infections. Current guidelines in most facilities advise doctors and nurses to sanitize their hands before and after visiting a patient’s room. Health care personnel may use such products up to a hundred times a day, according to the AP.
Recent research on antiseptics has caused concern because it appears the products are absorbed into the body at higher levels than previously thought. They show up in the blood and urine of users, the AP reports. The FDA wants manufacturers to submit data from both human and animal studies on absorption rates, blood levels, toxicology and possible links to cancer and hormonal problems. The FDA will then determine safety thresholds, with particular concern for vulnerable groups like pregnant and breastfeeding health care workers. The agency is also collecting information about possible links between hand sanitizers and the growth of “superbugs” that are resistant to antibiotics.
The FDA first began to evaluate antiseptic soaps and scrubs in 1972 under a law enacted to set guidelines for drugs and chemicals already on the market that had never been formally reviewed. The review of nearly 30 antiseptic ingredients has dragged on for decades. The most recent FDA review of health care hand cleaners came in 1994, according to the AP. The Natural Resources Defense Council filed suit against the FDA, accusing the agency of delaying action on potentially dangerous chemicals. In 2013 the FDA agreed to a legal settlement that included timetables for completing the review of chemicals including the hand sanitizers.
Environmentalists are concerned about triclosan, an ingredient in most antibacterial soaps sold to the public. The FDA issued a separate review of consumer products containing triclosan in late 2013. The agency determined it needed more data to establish their safety and effectiveness, the AP reports. Triclosan is less common in health care hand washes and cleaners than ingredients like alcohol and chloroxylenol, FDA officials say.