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FDA Seeks to Improve Safety of Antiseptic Swabs

Posted 14 Nov 2013 by Drugs.com

THURSDAY, Nov. 14 – Manufacturers of antiseptic swabs and solutions are being asked to make voluntary labeling and packaging changes, the U.S. Food and Drug Administration said Thursday. The goal is to improve the products' safety when applied to the skin before surgery or injections. Reports of infections linked to the over-the-counter antiseptics are infrequent but continuing, the agency said in a statement explaining its request. When used properly, these antiseptic swabs and solutions safely reduce the number of bacteria on patients' skin before they undergo an operation or receive shots. But use of contaminated antiseptics has led to localized infections and even death, according to the FDA. "Most often, contamination of [antiseptic products] occurs when organisms are introduced into the product by users," the agency said in the news release. The FDA is asking for labeling changes ... Read more

Related support groups: Chlorhexidine, Hibiclens, Benzalkonium Chloride, Peridex, Betasept, Benzethonium Chloride, Lugols Strong Iodine, Skin Disinfection, Preoperative, Benza, Lugols Solution, Dyna-Hex, Perisol, Lavacol, BD Butterfly Alcohol Pad, Denatured Alcohol, Zephiran Chloride, Butterfly Alcohol Pad, Hibistat Towelette, Biopatch, Chlorostat

FDA Medwatch Alert: Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

Posted 13 Nov 2013 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation.  When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections.  However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users.  Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection. Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and ... Read more

Related support groups: Chlorhexidine, Hibiclens, Benzalkonium Chloride, Peridex, Betasept, Benzethonium Chloride, Lugols Strong Iodine, Benza, Lugols Solution, Dyna-Hex, Perisol, Lavacol, BD Butterfly Alcohol Pad, Denatured Alcohol, Zephiran Chloride, Topical Disinfection, Butterfly Alcohol Pad, Hibistat Towelette, Biopatch, Chlorostat

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