AcipHex and Warfarin
Monday, August 04, 2008
PTINR.com Staff
Millions of people suffer from heartburn and reflux. Weekly patient self testing for those taking warfarin maybe alerted sooner of possible interactions with AcipHex than those patients testing less often.
AcipHex® (rabeprazole Sodium), a medication approved for the short-term treatment of gastrointestinal reflux disease (GERD), might present a safety risk to patients taking Coumadin® (warfarin).
Although the FDA first approved the use of AcipHex® in 2002 as a daily, short-term (up to eight weeks) treatment only for adult GERD patients, it was recently approved for use in adolescents 12 years and older.1 AcipHex® is a generally well-tolerated medication. Side effects that occurred in more than 2% of study patients include abdominal pain, diarrhea, and headache.2
In post-marketing trials of AcipHex®, increased INR values were observed in patients with concomitant warfarin use. High INR values can potentially increase the risk of bleeding and death in some patients.2 Therefore, the AcipHex® product label now includes recommendations for more frequent INR testing in warfarin (Coumadin ®) patients who also require AcipHex® treatment.
Weekly patient self-testing identifies such warfarin-drug interactions earlier than standard monthly INR monitoring. Patient self-testing requires a prescription, appropriate training, and the ability for the patient to communicate test results. Home INR testing is a covered benefit for Medicare patients with the following indications for warfarin therapy: atrial fibrillation, mechanical heart valve replacement, and venous thromboembolic disease.3
References:
FDA Approves AcipHex (rabeprazole Sodium) 20 Mg For Short-Term Treatment of GERD in Adolescents. (2008). Retrieved July 13, 2008, from Health Diseases Blog Web site: http://healthdiseases.org.cn/2008/07/fda-approves-aciphexr-rabeprazole-sodium-20- mg-for-short-term-treatment-of-gerd-in-adolescents.html
Eisai Incorporated. (2008). AcipHex [Package Insert]. Raritan, New Jersey.
Center for Medicare and Medicaid Services. (2008). Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087R) [Memorandum]. Baltimore, MD.