Reclast® medication & Warfarin

Publication Date: 
Tue, 11/08/2011
By: Alere Staff

Reclast® prescription medication, or zoledronic acid, manufactured by Novartis, received U.S. Federal Drug Administration (FDA) approval in August, 2007 as the first once-a-year treatment for postmenopausal osteoporosis.1 Women are four more times at risk for osteoporosis than men and the most frequent users of bone density medications.2

A three-year Reclast® medication study versus placebo demonstrated a 70% reduction of vertebral fractures, a 41% reduction in hip factures and a significant improvement in bone density. There was a slightly higher incidence of atrial fibrillation in the study group (2.4%) versus 1.9% in the control group.This suggests the incidences of developing atrial fibrillation were not related to the acute infusions.1

The Novartis package insert for Reclast® does not include a drug-to-drug interaction between Reclast and warfarin. Adverse reactions to Reclast did included flu-like symptoms, headache, fever, hypocalcemia, among others, but these were not associated with warfarin use.1

If maintaining bone density and preventing osteoporosis is a priority, choose a medication that works safely while taking warfarin. A discussion between doctor and patient is important before considering Reclast therapy. Patients on warfarin may react differently to the Reclast 15 minute, once-a-year injection.

More frequent International Normalized Ratio (INR) testing may be required, especially in the early weeks following a Reclast® medication injection.3 Increasing testing frequency is recommended when making any changes to your diet, medication, etc. Studies have shown that increasing testing frequency with weekly testing of INR improves patient safety and helps keep the drug in its therapeutic effective zone.4,5 Weekly testing was shown to be the most effective testing frequency.4 Medicare and many private/commercial insurance reimburse patients for weekly patient self-testing.6 Go to the Getting Started page or call Alere at 1.800.504.4032 for more information about testing your INR at home.

  1. Novartis, 2010 Web site: www.reclast.com Retrieved: February 10, 2010.
  2. National Osteoporosis Foundation, 2008.
  3. Bristol-Myers Squibb Company. Medication Guide for Coumadin Tablets and Coumadin for Injection [Package Insert]. Princeton, NJ: Bristol-Myers Squibb Company, 2009.
  4. Am J Manag Care. 2014;20(3):202-209.
  5. Heneghan C., et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. 2006. Lancet, 367, 404-11.
  6. Center for Medicare and Medicaid Services. Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management  (CAG-00087R) [Memorandum]. 2008. Baltimore, MD.