Recalls, Market Withdrawals, and Safety Alerts Important to GI

February 19, 2015
Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

The FDA is issuing a safety communication to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of duodenoscopes, used during a procedure known as Endoscopic Retrograde Cholangiopancreatography (ERCP) 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. The FDA’s safety communication contains recommendations for health care professionals, reprocessing facilities and patients, to help reduce the risk of infection.

ACG Note: Patients are reminded that the therapeutic benefit of ERCP usually outweighs the potential low risk of infection and that they should talk to their doctors about any concerns. ACG has been working with – and will continue to work with – the leadership of all other GI societies, the Centers for Disease Control & Prevention (CDC), the Food and Drug Administration (FDA), manufacturers and other groups to evaluate and address this complex issue.

Read the Joint GI Society statement.

May 13, 2014
FDA study of Medicare patients finds risks lower for stroke and death but higher for GI bleeding with Pradaxa vs. Warfarin

In its ongoing review of the blood thinner Pradaxa (dabigatran), the U.S. Food and Drug Administration (FDA) recently completed a new study in Medicare patients comparing Pradaxa to the blood thinner warfarin (Coumadin, Jantoven, and generics), for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF). The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

ACG Note: ACG has been working with the FDA on this issue of GI bleeding in patients taking Pradaxa. Please contact ACG staff if you or your practice have similar experiences in patients taking Pradaxa.

October 26, 2012
Class Recall: Ethicon Endo-Surgery Circular Stapler Sets – User Difficulty With Firing Stapler Devices

FDA announced a recall on October 26, 2012 for these products distributed from April 2011 to July 2012. According to the agency, users have had difficulty using the stapler device in procedures to treat prolapse or hemorrhoids.

August 14, 2012
Hospira announces a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL

On August 14, 2012 Hospira announced a nationwide recall of three lots of Propofol due to visible particles embedded in the glass to the user level. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.

February 9, 2012
FDA MedWatch – Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs

Drug Safety Communication – Hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together

February 8, 2012
FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)