FDA gives manufacturers a year to remove triclosan from healthcare antiseptics
The Food and Drug Administration is banning the use of an active ingredient commonly found in hospital antiseptic products, citing safety and efficacy concerns, but the ban won't begin for a full year.
The agency on Tuesday finalized a rule requiring makers of hand washes, hand rubs, surgical hand scrubs, surgical hand rubs, and patient antiseptic preoperative skin preparations to reformulate their products without the ingredient triclosan, a chemical that has been associated with health risks and a possible contributor to the development of antibiotic-resistant bacteria.
In all, 24 ingredients were cited as being "not generally recognized as safe and effective" by the FDA in its ruling, and they will be banned from the over-the-counter healthcare antiseptic product market effective Dec. 20, 2018. Products containing the banned ingredients will either have to be removed from the market, reformulated or undergo approval as a new drug application.
According the FDA, manufacturers have already stopped using 23 of the active ingredients cited in the rule with the exception of triclosan. In an email response to a question over what impact the rule might have on supplies of antiseptic products, a spokeswoman with the FDA's Center for Drug Evaluation and Research noted that the agency anticipated the rule will remove only "a small number of products" from the market and "consequently will have little impact on the industry".
The FDA has estimated healthcare professionals use antiseptic products as often as 100 times a day. But the increased use of such products have raised a number of questions over their safety and effectiveness as hospitals have sought to take stronger measures to reduce the number of infections acquired in healthcare settings.
More than 700,000 patients developed infections in acute-care hospitals in 2011, according to the Centers for Disease Control and Prevention, resulting in an estimated 75,000 deaths.
The agency delayed making a determination on five other active ingredients: benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl or isopropyl alcohol, and povidone-iodine, allowing product makers one year to provide more evidence that proves the ingredients are safe and effective.
The American Cleaning Institute, a trade organization for soap and cleaning-product makers, released a statement praising the FDA's decision to delay action on those five active ingredients. ACI Executive Vice President Richard Sedlak said the industry needed more time to provide additional safety and efficacy data for what he deemed were "critically important ingredients used in healthcare antiseptic products".
"Manufacturers need sufficient time to provide FDA with additional safety and efficacy data to support the continued use of these products in healthcare facilities," Sedlak said.
Tuesday's rule follows regulatory action the FDA began in 2013 when it issued a proposed rule requiring manufacturers to provide data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes.
Last year, the agency banned over-the-counter consumer antibacterial washes that contained 19 active ingredients, including triclosan, after determining such products were no more effective than plain soap and water.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said at the time of the action that it was being done because of data that suggested that antibacterial ingredients may do "more harm than good over the long term."
The FDA estimated Tuesday's final rule would reduce human exposure to triclosan by 88,000 kilograms annually. A 2007 study published in the journal Clinical Infectious Diseases found soaps containing triclosan were associated with no "additional health benefit" over regular soap but carried a potential risk for drug resistance.
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