NGC Update Service: March 9, 2015 ► U.S. Food and Drug Administration (FDA) Advisories

NGC Update Service: March 9, 2015

U.S. Food and Drug Administration (FDA) Advisories

• March 3, 2015: Testosterone Products: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.
• February 19, 2015: Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.