May 07, 2015
After roughly 40 years, U.S. health regulators are seeking data to see if the cocktail of ingredients in antiseptics used in hospitals, clinics and nursing homes are as safe and effective as they were once considered.
The Food and Drug Administration said on Thursday it is asking manufacturers for more data, including on absorption, potential hormonal effects and bacterial resistance of the 'active' ingredients in antiseptics, to see if they are still appropriate for use in a healthcare setting.
Since the review of healthcare antiseptics in the 1970s, things have changed, the FDA noted, alluding to a shift in frequency of use, hospitals' infection control practices, technology and safety standards.
An independent panel of experts to the FDA raised similar concerns last year. In 2013, the regulator issued a warning to manufacturers, saying it was aware of at least four deaths and multiple infections caused by over-the-counter antiseptics.
Commonly used active ingredients in healthcare antiseptics include alcohol and iodine. Data suggests that, for at least some of these ingredients, the systemic exposure is higher than previously thought, the agency noted.
"We're going to try to answer their questions in great detail as called for, but we believe the FDA already has sufficient data on these products," said Brian Sansoni, a spokesman for American Cleaning Institute (ACI), a trade association for the cleaning products industry.
The ACI represents antiseptic ingredient and product makers such as Gojo Industries Inc, the maker of Purell hand sanitizers; Dial Corp, a unit of Germany's Henkel <HNKG_p.DE>; Ecolab Inc and Steris Corp.
The FDA said no healthcare antiseptics were going to be pulled off shelves as of now, and that their review excluded home-use antiseptics such as antibacterial soap and hand sanitizers.
The new data request relates only to healthcare antiseptics covered by the over-the-counter monograph, a kind of "recipe book" covering acceptable ingredients, doses, formulations and labeling. Once a final monograph is implemented, companies can market their product without having to go through the FDA.
Companies will have one year to submit the data, which the FDA will evaluate before determining if the OTC monograph needs to be revised.
"We're concerned if the FDA takes maybe a too narrow view regarding the safety and effectiveness data – depending how the final rule ends up – they could take effective products or ingredients off the shelves," Sansoni said.