The U.S Food and Drug Administration (FDA) has proposed a new rule requesting further investigations into certain active ingredients found in health care antiseptics.
These common antiseptics are marketed under the over-the-counter drug monograph, and are primarily used by healthcare professionals. They include hand washes and rubs, surgical hand scrubs, and preoperative skin preparations.
"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 (CDER). "The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered."
The most common active ingredient in these products include alcohol and iodines, which is different from consumer antiseptics found in homes. Past studies have found systemic exposure of these products is higher than previously believed, which raises concerns about the effects of repeated daily use.
"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."
The new rule does not require these antiseptics to be removed from shelves, but rather requires manufacturers who wish to keep marketing them under the monograph to provide additional data on the safety and effectiveness of the active ingredients, such as "absorption, potential hormonal effects and development of bacterial resistance."
