FDA wants safety data on OTC antiseptics used in hospitals

June 5, 2015

The FDA wants more scientific data to support the safety of active ingredients in antiseptics in hospitals, clinics, nursing homes, and other healthcare facilities.

The FDA wants more scientific data to support the safety of active ingredients in antiseptics in hospitals, clinics, nursing homes, and other healthcare facilities.

Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the FDA is requesting additional scientific data in its proposed rule, to demonstrate that healthcare antiseptics in the over-the-counter (OTC) drug monograph are generally recognized as safe and effective (GRASE).

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Emerging science suggests that, for at least some healthcare antiseptic active ingredients, systemic exposure (full-body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients, according to an FDA statement.

Long-term safety data

“The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the healthcare setting and on the use of these products by certain populations, including pregnant and breastfeeding healthcare workers, for which topical absorption of the active ingredients may be important,” the statement said.

“Today healthcare professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,” said Theresa Michele, MD, director of CDER’s Division of Nonprescription Drug Products. The proposed rule “seeks to ensure the FDA’s evaluations and determinations for all healthcare antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by healthcare professionals,” Michele added.

The antiseptics in question 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 the antiseptics, marketed under the over-the-counter drug monograph, include alcohol and iodines.

 

Manufacturers to provide more data

The proposed rule does not require any healthcare antiseptic products to be removed from the market currently. Instead, it requires manufacturers that want to continue marketing healthcare 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.

“The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER).

Interested parties can submit electronic or written comments to the FDA by October 28, 2015. 

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