FDA reviewing safety, efficacy of OTC antiseptics
SILVER SPRING, Md. - The U.S. Food and Drug Administration on Thursday proposed to review the safety and effectiveness of certain active ingredients used in OTC antiseptics. However, the agency is not advocating any change in wound care treatment at this time.
“Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.”
The review is routine, the agency noted. "Since the FDA began review of health care antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use," the agency stated.
Emerging science also suggests that for at least some health care antiseptic active ingredients, systemic exposure is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients. The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.
“Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,” said Theresa Michele, director of CDER’s Division of Nonprescription Drug Products. “Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals.”
Health care antiseptics include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. The most common active ingredients in health care antiseptics marketed under the OTC monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.
The proposed rule does not require any health care antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing health care antiseptic products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects and development of bacterial resistance. Once the proposed rule is finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available.
Today’s action is part of the FDA’s larger, ongoing review of monograph antiseptic active ingredients, FDA noted, and does not affect health care antiseptics approved under the New Drug Application process, consumer antiseptic products or consumer hand sanitizers.