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FDA Issues Safety Requests for Topical Antiseptic Products

Filed November 14th, 2013 Laurie

The U.S. Food and Drug Administration (FDA) requested label and packaging changes for certain over-the-counter (OTC) topical antiseptic products in the wake of reports of serious and sometimes deadly side effects.

The FDA said in a press release issued yesterday that contamination of topical antiseptic products can occur when organisms are introduced into them by users. Outbreaks linked to topical antiseptics appear in medical literature and have been reported to the U.S. Centers for Disease Control and Prevention (CDC). Clinical infections reported to the FDA prompted past recalls.

According to the press release, the FDA has reviewed reports of four deaths, five cases of wound infection, seven cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site infection, and 32 cases of bacteremia, bacteria-infected blood. These infections have been confirmed to be caused by contaminated antiseptic products containing common antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products.

The FDA wrote that commonly used products contain isopropyl or ethyl alcohol, povidone iodine, poloxamer iodine, benzalkonium chloride, benzethonium chloride, or chlorhexidine gluconate as a single agent or in combination with alcohol. These products are sold as solutions, swabs, pads saturated with a solution, and applicators containing a solution.

The agency recommends that topical antiseptic manufacturers package the products indicated for preoperative or pre-injection skin preparation in single-use containers. The FDA also recommends that the products be used exactly as directed on the label, that single-use containers should be used only one time on one patient, that the products are not diluted once they are opened, and applicators and any unused solution be discarded after the single application.

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