The Food and Drug Administration is calling for more data about antiseptic sanitizers used in health care settings, including hospitals.
The request applies to such products as antibacterial soaps and hand washes. The federal agency wants to determine if the products are as safe and effective as they were 40 years ago, the last time the organization thoroughly investigated the subject.
Antiseptic manufacturers are being asked to supply the FDA with information on how their products may affect the rise of antibiotic-resistant microorganisms, as well as absorption into the bodies of users, and about possible hormonal effects.
Alcohol and iodine are commonly used as active ingredients in many professional antibacterial products, and the agency is concerned that exposure to these chemicals is higher than previously believed.
"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, spokesperson for the American Cleaning Institute (ACI), which represents manufacturers of products such as Dial soap and Purell hand sanitizer.
The FDA states its current review would not affect home use of antibacterial soaps and lotions and that it does not intend, at this time, to pull any products from store shelves. The request applies only to products created following the monograph, a type of recipe book outlining certain chemical combinations, doses and labeling etiquette. Companies will be able to market products without FDA approval once a final version of the monograph is complete.
"Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection. The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered," Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said.
Antiseptics used in the workplace are commonly used in nursing homes, doctor's offices, clinics and hospitals, and the FDA wants to know these products are still safe and effective when used as directed.
The use of these sanitizers has changed over the last 40 years, including the knowledge of dangers of antibiotic-resistant organisms. It is also now possible to detect the presence of antiseptic chemicals in bodies at levels far lower than what could be seen in the 1970s. This could help reveal whether health care workers, especially those who are pregnant or breastfeeding, are taking the chemicals in through their skin over time.
The FDA is accepting public comment for 180 days, and manufacturers will have one year to submit the requested data. Following a 60-day rebuttal period, the agency will issue its ruling in the form of a revised final monograph.
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