If you have been diagnosed with atrial fibrillation (AF), chances are you’re being prescribed a blood thinner like Coumadin (warfarin). Even though warfarin medication has the benefit of reducing the risk of stroke, it comes with its own risks and side effects.
As of October 9, 2006, the U.S. Food and Drug Administration (FDA) requires that Coumadin be labeled with a black box warning. A black box warning label appears on a prescription’s packaging when the FDA finds that a drug poses a serious and significant public health risk. The FDA required the warning for Coumadin based on studies confirming drug risks due to “major or fatal bleeding.”
A study published in 2006 found that people who took warfarin for more than a year were 25% more likely to suffer an osteoporotic fracture of the hip, spine or wrist than people who either had taken warfarin for less than a year or who had not taken warfarin at all. Of the warfarin users who suffered a fracture: 65% broke a hip, 19% broke a vertebra, 10% broke a wrist, and 5% had more than one fracture. The 30-day mortality rates were 39% after hip fracture, 37% after vertebra fracture, 25% after wrist fracture and 26% after multiple fractures. For patients on long term warfarin treatment, men had fractures 63% more often than women. The study does not reach any definitive conclusions about the correlation between long-term warfarin use and bone fractures, but researchers hypothesize that the inhibitors of blood clotting factors may also suppress bone matrix proteins.
Patients taking Coumadin (warfarin) may experience one or more of these risks and/or side effects:53
This is a partial list. A complete list of risks and side effects for Coumadin is available at the FDA online or from Bristol-Myers Squibb full prescribing information.
A study conducted at Massachusetts General Hospital in Boston looked at physician-cited reasons for not prescribing warfarin to patients who presented with ECG-documented atrial fibrillation at the time of medical treatment. Of 405 patients who met the standards of the study criteria, only 51% were prescribed warfarin.56 Of the 49% who were not prescribed warfarin, 97% had at least one high risk factor for stroke and 83% had at least two high risk factors for stroke.56 These patients were not prescribed warfarin because of physician-cited contraindications. Those contraindications included history of hemorrhage, history of falling, patient intolerance, and mental impairment.
In the summary of the Boston study, the researchers noted that despite the first published evidence of warfarin's effectiveness 16 years ago, prevention against stroke in atrial fibrillation remains suboptimal. Given the aging of the population, stroke prevention in atrial fibrillation is a pressing health imperative.56
If you are contraindicated for warfarin, you should ask your doctor about other therapies, such as catheter ablation and surgical ablation. Certain surgical ablation procedures include the excision or exclusion of the left atrial appendage. Candidacy for surgical ablation procedures is dependant upon the patient's health and ability to undergo surgery.
Your doctor can help you decide what your treatment options are based upon the type of atrial fibrillation you have and your overall health and medical history. Take the time to educate yourself about your treatment options, write down questions to ask your doctor at your next follow-up, and speak to your physician about your options and concerns. If you are a patient or physician and are interested in learning additional information about clinical studies currently underway, please visit clinicaltrials.gov.
Coumadin® is a registered trademark of Bristol-Myers Squibb. For the most recent information about Coumadin®, prescription information and precautions, please visit www.coumadin.com.
