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FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics

Posted 30 Apr 2015 by Drugs.com

April 30, 2015 – The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. “Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.” Health care antiseptics are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing ho ... Read more

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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, Skin Disinfection, Preoperative, Dyna-Hex, Betasept, Isopropyl Alcohol, Perisol, Benzethonium Chloride, Denatured Alcohol, Lugols Strong Iodine, Periogard, Lugols Solution, Pedi-Pro (Benzalkonium), Topical Disinfection, Hibistat, Calgon Vesta, PerioChip, Alcare Plus

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, Dyna-Hex, Betasept, Isopropyl Alcohol, Perisol, Benzethonium Chloride, Denatured Alcohol, Lugols Strong Iodine, Periogard, Lugols Solution, Pedi-Pro (Benzalkonium), Hibistat, Calgon Vesta, PerioChip, Alcare Plus, Iodine Mild, Denti-Rinse

Health Tip: Clean a Wound Carefully

Posted 25 Jan 2012 by Drugs.com

-- When you get a cut, scrape or minor puncture wound, careful cleaning can help prevent an infection. The American Academy of Family Physicians offers these suggestions for cleaning a minor wound: Run cool water over the wound, either by pouring from a cup or holding the area under running water. Using a soft washcloth and soap, gently clean the skin. Avoid applying soap directly in the wound. Clean a pair of tweezers with isopropyl alcohol, then use the tweezers to remove any dirt or debris in and around the wound. Avoid using strong cleansing solutions such as hydrogen peroxide or iodine. Use plain water unless otherwise directed by a doctor. Read more

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