Recalls, Market Withdrawals, and Safety Alerts Important to GI

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.

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.

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.

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

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

FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria

FDA withdraws Halflytely and Bisacodyl Tablets Bowel Prep Kit from market for safety and effectiveness reasons
The Food and Drug Administration (FDA) has determined that Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg.

FDA reports of a rare cancer of white blood cells primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with tumor necrosis factor (TNF) blockers

Prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time
FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia.

Federal government issues joint-safety announcement re: Preventing Cross-Contamination in Endoscope Processing

FDA Drug Safety Communication: PPIs and Possible Fracture Risk

Recall: Baxter Colleague Pump

Plavix – Boxed Warning

FDA Recommendation on Plavix and PPIs