FDA committee quashes recommendation to reclassify ethanol, isopropyl alcohol, and iodine.
An FDA advisory committee has decided against moving a trio of popular antiseptics to a different safety and efficacy category, noting the change could increase infection risk by reducing hand washing among health care professionals, Medscape reports.
Had the panel recommended the move, ethanol, isopropyl alcohol, and iodine would have shifted to safety Category III, which means there is insufficient data to classify the substances as safe and effective. The antiseptic ingredients are currently classified as Category I, under which OTC drug products are generally deemed safe and effective for their intended use.
The committee’s decision hinged on both history and evidence, as it considered that health care providers have used the 3 antiseptics for decades, and no data has demonstrated that the chronic use of the products is unsafe. In addition, the committee members felt the change could reduce hand washing compliance, thus increasing infection risk within the general public, Medscape reported.
At the September 3, 2014, meeting, the FDA committee unanimously recommended proposing new safety standards for 11 common OTC health care antiseptic ingredients. If the new standards are implemented, 5 ingredients—including the 2 types of alcohol, as well as 3 types of iodine—would be generally recognized as safe and effective, while benzalkonium chloride, benzethonium chloride, chloroxylenol, hexylrescorcinol, triclocarban, and triclosan would be placed in Category III.
The FDA staff members proposing the changes referenced new data on OTC antiseptics that covered exposure to topical antiseptic ingredients, potential hormonal effects, and cutaneous absorption. The new regulation would only cover active ingredient use, not subsequent marketed formulations, Medscape noted.