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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.
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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.
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. Along with other useful
information, the site also provides information on the
location of anticoagulation clinics throughout the
United States and abroad.
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.
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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.
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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
New 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.
Presentations
(these are PowerPoint Presentations, which must be
viewed in Microsoft Explorer)
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.
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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:
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General Advice on Safe Medication Use
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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
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