Health & Medicine
FDA Calls To Look Into Safety Of Hospital Antiseptics
Kathleen Lees
First Posted: Apr 30, 2015 09:43 PM EDT
Hospitals are full of sanitizers to help keep germs away. Yet now, the U.S. Food and Drug Administration (FDA) has sought out additional information regarding the safety and effectiveness of certain active ingredients found in antiseptics that are commonly used by health care professionals, according to Reuters.
"Emerging science [suggests that] systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients," the FDA said, in a statement, adding that the "additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important."
As alcohol and iodines are most commonly used in active ingredients like antiseptics, the addition of home-use antiseptics like antibacterial soaps and hand sanitizers were not included in the evaluation and would not be forced out of the market at this time.
Yet new information suggests that some active ingredients in antiseptics could be higher than previously thought, which may potentially be dangerous to our health.
"Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day," said Theresa Michele, director of CDER's Division of Nonprescription Drug Products. "Today's proposal seeks to ensure the FDA's evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals."
The proposal will be open to public comment for 6 months. "Concurrently, companies will have 1 year to submit new data and information, followed by a 60-day rebuttal comment period," the agency concluded. "The FDA will then evaluate all the data and comments that were received in response to this proposal to make a final determination regarding GRASE [generally recognized as safe and effective] status for each active ingredient."
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First Posted: Apr 30, 2015 09:43 PM EDT
Hospitals are full of sanitizers to help keep germs away. Yet now, the U.S. Food and Drug Administration (FDA) has sought out additional information regarding the safety and effectiveness of certain active ingredients found in antiseptics that are commonly used by health care professionals, according to Reuters.
"Emerging science [suggests that] systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients," the FDA said, in a statement, adding that the "additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important."
As alcohol and iodines are most commonly used in active ingredients like antiseptics, the addition of home-use antiseptics like antibacterial soaps and hand sanitizers were not included in the evaluation and would not be forced out of the market at this time.
Yet new information suggests that some active ingredients in antiseptics could be higher than previously thought, which may potentially be dangerous to our health.
"Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day," said Theresa Michele, director of CDER's Division of Nonprescription Drug Products. "Today's proposal seeks to ensure the FDA's evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals."
The proposal will be open to public comment for 6 months. "Concurrently, companies will have 1 year to submit new data and information, followed by a 60-day rebuttal comment period," the agency concluded. "The FDA will then evaluate all the data and comments that were received in response to this proposal to make a final determination regarding GRASE [generally recognized as safe and effective] status for each active ingredient."
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone