Oral Anticoagulant Research and Resources for Patients and Caregivers

 
Focus on Genetic Testing

FDA Approves updated oral anticoagulant prescribing information on genetic testing
(Aug. 2007)
FDA approved updated labeling including new information for the widely used blood-thinning drug, Coumadin. This new information explains that people's genetic makeup may influence how they respond to the drug. Specifically, people with variations in two genes may need lower warfarin doses than people without these genetic variations. The two genes are called CYP2C9 and VKORC1. The CYP2C9 gene is involved in the breakdown (metabolism) of warfarin and the VKORC1 gene helps regulate the ability of warfarin to prevent blood from clotting. For more information, click here.

For more information on genetic testing, including concerns about how information about genotype testing will be added to the label, see the Anticoagulation Forum newsletter here.

This issue of the newsletter includes a letter from the AC Forum Board of Directors to Dr. Lawrence Lesko, Director, Office of Clinical Pharmacology at the FDA. The letter outlines the AC Forum's concerns about the FDA's plan to add information about genotype testing to the warfarin package insert. The newsletter also includes Dr. Lesko's response letter.
Research on Oral Anticoagulants

To hear firsthand from those directly involved in the issues and challenges associated with safe oral anticoagulant use, NCL commissioned Bearing Point to conduct focus group research with three different population groups: patients, pharmacists, and general practice/internal medicine physicians. The results of this effort are available here.

 

The Use of Oral Anticoagulants: Key Findings from Surveys of Patients, Caregivers, and Physicians (executive summary)

 

To request a copy of the entire 150-slide survey presentation, please email us.

Information on Strokes and Other Conditions Related to Oral Anticoagulants

American Heart Association

This site provides information on how to recognize the signs of stroke.

 

Food and Drug Administration

This brochure, Aspirin for Reducing Your Risk of Heart Attack and Stroke: KNOW THE FACTS, explains why you need to work with your health professional when choosing and using aspirin to lower the risk of heart attack and stroke.

 

National Stroke Association

The National Stroke Association wants you to know that atrial fibrillation (AF) is a controllable risk factor for stroke. AF is an irregular heartbeat that can allow blood to pool in the heart causing blood clots which may move to the brain causing a stroke. Blood thinning medication is one of the treatments for this condition.

Other Information on Using Medications Safely:

AARP

This site contains resources to help people safely and effectively manage their medications.

 

Institute for Safe Medication Practices (ISMP)

The Institute for Safe Medication Practices (ISMP) is a nonprofit organization devoted entirely to medication error prevention and safe medication use. ISMP represents over 30 years of experience in helping healthcare practitioners keep patients safe, and it continues to lead efforts to improve the medication use process.

ISMP provides useful information for consumers on the following topics:

·         General Advice on Safe Medication Use

·         Lessons to be Learned from Past Errors

·         Preventing Drug Errors in Children

·         Safe Medicine, the ISMP Medication

·         Safety Newsletter for Consumers

·         ISMP Patient Safety Brochure

FDA Information

FDA Medication Guide for Oral Anticoagulant Coumadin Oct. 2006

The Food and Drug Administration (FDA) and Bristol-Myers Squibb (manufacturers of Coumadin) have recently notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients. Click here for more information. FDA regulations require a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. Information about all currently approved Medication Guides is available here.

 

General Information on Use of Oral Anticoagulants

AHRQ Patient Guide to Coumadin/warfarin therapy

This guide was put together by the Agency for Healthcare Research and Quality (AHRQ) to provide patients with helpful information about Coumadin/warfarin therapy.

New! Now available in Spanish!

AHRQ's new pamphlet, Su guia para el trat amiento con Coumadin/warfarina (Your Guide to Coumadin®Warfarin Therapy), can help Spanish-speaking patients know what to expect and watch out for while using the blood thinner Coumadin®/warfarin.  This 13-page, easy-to-read brochure educates patients about their medication therapy and potentially dangerous side effects, explains how to communicate effectively with their health care providers and provides tips for lifestyle modifications. It also provides information on remembering when to take the medicine, learning how to stay safe while taking the medicine, maintaining a consistent diet and alerting health care providers to concurrent drugs and/or supplements to avoid any potential adverse interactions.  An English-language Your Guide to Coumadin®/Warfarin Therapy also is available.  Printed copies are available by sending an e-mail to ahrqpubs@ahrq.hhs.gov.

Anticoagulation Forum

This site is run by a network of health care professionals committed to the therapy of thromboembolic disorders predominantly through the venue of anticoagulation management service. Through the exchange of information, medical education, and scientific investigation, the Forum promotes professional development and the enhancement of the quality of anticoagulation care. 

ClotCare Online Resource: Helping others improve lives through anticoagulation

This site provides information about different types of medicines and treatments that may be used by individuals on oral anticoagulation therapy.

 

DrugDigest

This resource provides easy-to-understand information for safe and effective use of warfarin. Pill identification photos, drug interactions checker, and printable medication cards are also available. 

Mayo Clinic.com: Tools for healthier lives

This resource provides helpful information about how to safely and effectively manage oral anticoagulation therapy.

National Library of Medicine/National Institutes of Health

This resource provides helpful information about how to safely and effectively manage oral anticoagulation therapy.

The National Alliance for Thrombosis and Thrombophilia (NATT)

This site is run by a nationwide alliance of patients and medical professionals committed to preventing and treating health problems caused by blood clots. They promote awareness, early diagnosis, and optimal treatment through research, education, support, and advocacy.

 

WarfarinDosing

This site helps health care practitioners begin warfarin therapy by estimating the dose in new patients. The estimates are based on clinical factors and, when available, genotypes of two genes.

 

Focus on Special Populations

The Heart Surgery Forum: A cardiothoracic multimedia journal. This resource provides helpful information for the parents or caregivers of teenagers taking warfarin.

 

Focus on Diet

Important Drug and Food Information. This handout provides helpful dietary information about the interaction between warfarin and vitamin K. This material was originally put together for individuals participating in the NIH research setting.

American Academy of Family Physicians. This resource provides information from a clinical study showing that American ginseng can reduce the efficiency of warfarin.

 

This information is not a substitute for the medical advice of a qualified health care provider, and we urge you to visit a qualified physician for diagnosis and for answers to your questions.

Copyright 2009 National Consumers League