FDA Wants Data to Support Antiseptic Claims

Agency also plans to require more safety data on topical germicides for healthcare use. 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. It added that it wants "additional data on the long-term safety of daily, repeated exposure to these ingredients in the healthcare setting and on the use of these products by certain populations, including pregnant and breastfeeding healthcare workers, for which topical absorption of the active ingredients may be important." The new rules only apply to antiseptics sold for use in healthcare settings, not consumer products such as antibacterial soaps or hand sanitizer rubs, the FDA emphasized. http://www.medpagetoday.com/HospitalBasedMedicine/InfectionControl/51289?xid=nl_mpt_DHE_2015-05-01&eun=g721819d0r&userid=721819&mu_id=5883165