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article imageFDA seeking information on hand sanitizers to 'fill in the gaps'

By Karen Graham     Jun 29, 2016 in Health
Hand sanitizers are everywhere we go today, from disposal wipes at the grocery store to little plastic bottles we carry in our purse or pocket. But just how safe and effective are they? That is what the FDA wants to know.
Digital Journal readers may remember that last May, we reported the Food and Drug Administration (FDA) was requesting additional safety and effectiveness data for active ingredients in a broad range of products used in the healthcare setting.
This year, the FDA is focusing on topical consumer antiseptic rubs, including hand sanitizers marketed over-the-counter (OTC). In the agency's statement, published on Wednesday, the FDA said more data is needed to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns.
The FDA also stressed it was not indicating the products are not safe to use or do not work, just as it said last year when requesting additional data on health-care related sanitizers. This time, the agency points out that in a few studies, there was a vague indication that some of the ingredients might be absorbed through the skin, according to NBC News.
Knowing if some of the ingredients, including ethanol or ethyl alcohol, isopropyl alcohol, and benzalkonium chloride can be absorbed through the skin, as well as their concentrations is doubly important, especially if they are being used by pregnant women and small children, says the FDA. "Since 2009, 90 percent of hand sanitizers used ethyl alcohol as their active ingredient," the FDA said.
"Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Dr. Woodcock points out that it is the agency's responsibility to ensure the products being used multiple times a day on small children and others are safe and effective. "To do that, we must fill the gaps in scientific data on certain active ingredients," she adds.
With the rise in the number of antibiotic-resistant pathogens, the FDA says the new data it is requesting could suggest the hand sanitizers may be playing a role in bacterial resistance. As of this time, nothing is being pulled off the market.
As everyone should already know, the best way to clean hands is by washing them with soap and water. The soap helps the water to wash away germs.
More about hand sanitizers, Fda, formal review, data on alcohol, antiseptic
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