FDA Calls for More Safety Data on Antiseptics

The FDA is requesting more data on the safety and efficacy of certain health care antiseptic active ingredients.

These antiseptics include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations, which are all primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings, and nursing homes to reduce bacteria that potentially can cause disease.

The most common OTC active ingredients in these antiseptics are alcohol and iodines, which differ from consumer antiseptics like antibacterial soaps and hand sanitizer rubs that are not included in the FDA’s proposed rule.

Infection control practices and FDA safety standards have changed since the agency originally began reviewing health care antiseptics in the 1970s. Now, new technology can detect low levels of antiseptics in the body, and emerging data have pointed to greater full body exposure to health care antiseptic active ingredients than previously thought.

Citing existing data that raised concerns about the effects of repeated exposure to some of these active ingredients, the FDA is requesting more scientific findings on the long-term safety of daily exposure, especially among pregnant and breastfeeding health care workers for whom topical absorption may be critical.

The FDA noted its request does not mean it considers the active ingredients unsafe or ineffective.