FDA Needs to See More Safety Data on Hospital Antiseptics

May 6, 2015

Manufacturers of over-the-counter antiseptics used in healthcare settings will need to submit new safety data to the FDA if they want to keep their products on the market, the agency said, citing growing concerns about the systemic effects of long-term exposure to certain active ingredients.

Specifically, the agency is worried about absorption, hormonal effects and the potential for bacterial resistance to ingredients that healthcare workers come into contact with hundreds of times a day.

The requirements, laid out in a proposed rule, are meant to bring the FDA’s standards in line with new patterns of antiseptic use and infection control practices and better tests for systemic exposure since the agency began evaluating these products.

While some data points to long-term systemic effects of alcohol and triclosan, many other APIs haven’t been evaluated for critical elements, such as dosing amount and frequency, application method, duration of exposure, product formulation and the skin condition and age of the individual, the FDA says.

This is especially important, as regulators are learning that some ingredients — such as triclosan and triclocarbon — can alter thyroid and reproductive hormones, and their effects on pregnant and nursing women and on children are not known, the agency adds.

Under the proposed rule, sponsors would need to demonstrate the range of in vitro antimicrobial activity against normal flora and bacteria on the skin — either by using minimum inhibitory concentration tests to prove the product can inhibit the growth of real-life clinical samples and laboratory strains, or via minimum bactericidal concentration tests that show the level of product concentration needed to completely kill the organisms in question.

The proposal applies to hand washes, hand rubs, surgical hand scrubs, surgical hand rubs and patient preoperative skin preparations.
Comments are due Oct. 28 to regulations.gov, docket no. FDA-2015-N-0101. Read the summary and the proposed rule at www.fdanews.com/04-30-15-antisepticsrule.pdf. — Lena Freund