[PHNUTR-L] FDA-Approved Drug Information Now Required for the BloodThinner Warfarin (COUMADIN)

[Kathrynne Holden]

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The Food and Drug Administration (FDA) announced on October 10, 2006,
that agency-approved written drug information, called a Medication
Guide, will now, belatedly, be required with all new and refill
prescriptions for the blood thinner (anticoagulant) warfarin (COUMADIN).

Worst Pills, Best
Pills News Online Drug E-Alert
http://www.citizen.org.


Warfarin is a very important and widely-used drug in preventing the
formation of life-threatening blood clots. In 2005, there were 22
million prescriptions filled for the drug.  However, it interacts with a
number of other drugs, dietary supplements, and vitamins. When used
improperly, warfarin can lead to potentially life-threatening bleeding
episodes. The medications with which warfarin interacts are inexplicably
not listed in the Medication Guide. In our book, Worst Pills, Best Pills
and on our website, Worstpills.org, we have warned about these serious
interaction problems, list the interacting drugs, and have continually
updated the information.

The FDA has the regulatory authority to require the distribution of
Medication Guides by pharmacists for drugs that pose a serious and
significant public health concern. However, at this time, there are only
approximately 75 drugs that require Medication Guides out of the
thousands of drugs on the market. A list of these drugs with links to
their respective Medication Guides can be found on the FDA's Web site
at: http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

The new warfarin Medication Guide is reproduced below.

What You Can Do

You should ask your pharmacist for a Medication Guide if you are
currently taking warfarin. Look up the information concerning drug
interactions on Worstpills.org.

Make sure you get a Medication Guide with each refill prescription for
warfarin as it may contain new updated information.



MEDICATION GUIDE
COUMADIN(COU-ma-din) Tablets
(Warfarin Sodium Tablets, USP) Crystallin

Read this Medication Guide before you start taking COUMADIN (Warfarin
Sodium) and each time you get a refill. There may be new information.
This Medication Guide does not take the place of talking to your
healthcare provider about your medical condition or treatment. You and
your healthcare provider should talk about COUMADIN when you start
taking it and at regular checkups.

What is the most important information I should know about COUMADIN?

Take your COUMADIN exactly as prescribed to lower the chance of blood
clots forming in your body. (See "What is COUMADIN?").

COUMADIN is very important for your health, but it can cause serious
and life-threatening bleeding problems. To benefit from COUMADIN and
also lower your chance for bleeding problems, you must:

         Get your regular blood test to check for your response to
COUMADIN. This blood test is called a PT/INR test. The PT/INR test
checks to see how fast your blood clots. Your healthcare provider will
decide what PT/INR numbers are best for you. Your dose of COUMADIN will
be adjusted to keep your PT/INR in a target range for you.

         Call your healthcare provider right away if you get any of the
         following signs or symptoms of bleeding problems:

         pain, swelling or discomfort
         headaches, dizziness, or weakness
         unusual bruising (bruises that develop without known cause or
grow in size)
         nose bleeds
         bleeding gums
         bleeding from cuts takes a long time to stop
         menstrual bleeding or vaginal bleeding that is heavier than
normal
         pink or brown urine
         red or black stools
         coughing up blood
         vomiting blood or material that looks like coffee grounds

Many other medicines, including prescription and non-prescription
medicines, vitamins and herbal supplements can interact with COUMADIN
and:

         affect the dose you need, or

         increase COUMADIN side effects.

Tell your healthcare provider about all the medicines you take. Do not
stop
medicines or take anything new unless you have talked to your
healthcare
provider. Keep a list of your medicines with you at all times to show
your
healthcare provider and pharmacist.

Do not take other medicines that contain warfarin. Warfarin is the
active ingredient in COUMADIN.

Some foods can interact with COUMADIN and affect your treatment and
dose.

         Eat a normal, balanced diet. Talk to your doctor before you make
any diet changes. Do not eat large amounts of leafy green vegetables.
Leafy green vegetables contain Vitamin K. Certain vegetable oils also
contain large amounts of Vitamin K. Too much Vitamin K can lower the
effect of COUMADIN.

         Avoid drinking cranberry juice or eating cranberry products.
         Avoid drinking alcohol.

Always tell all of your healthcare providers that you take COUMADIN.
Wear or carry information that you take COUMADIN.

What is COUMADIN?

COUMADIN is an anticoagulant medicine. It is used to lower the chance
of blood clots forming in your body. Blood clots can cause a stroke,
heart attack, or other serious conditions such as blood clots in the
legs or lungs.

Who should not take COUMADIN?

Do not take COUMADIN if:

your chance of having bleeding problems is higher than the possible
benefit of treatment. Your healthcare provider will decide if COUMADIN
is right for you.

Talk to your healthcare provider about all of your health conditions.

you are pregnant or plan to become pregnant. COUMADIN can cause death
or birth defects to an unborn baby. Use effective birth control if you
can get pregnant.

you are allergic to warfarin or to anything else in COUMADIN.

What should I tell my healthcare provider before starting
COUMADIN?

Tell your healthcare provider about all of your health conditions,
including if you:

         have bleeding problems
         fall often
         have liver or kidney problems
         have high blood pressure
         have a heart problem called congestive heart failure
         have diabetes
         drink alcohol or have problems with alcohol abuse. Alcohol can
         affect your COUMADIN dose and should be avoided.
         are pregnant or planning to become pregnant. See "Who should not
         take COUMADIN?"
         are breastfeeding. COUMADIN may increase bleeding in your baby.
         Talk to your doctor about the best way to feed your baby. If
you choose to breastfeed while taking COUMADIN, both you and your baby
should be carefully monitored for bleeding problems.

Tell your healthcare provider about all the medicines you take
including
prescription and non-prescription medicines, vitamins, and herbal
supplements. See "What is the most important information I should know
about COUMADIN?"

How should I take COUMADIN?

Take COUMADIN exactly as prescribed. Your healthcare provider will
adjust your dose from time to time depending on your response to
COUMADIN.

You must have regular blood tests and visits with your healthcare
provider to monitor your condition.

Take COUMADIN at the same time every day. You can take COUMADIN either
with food or on an empty stomach.

If you miss a dose of COUMADIN, call your healthcare provider. Take the
dose as soon as possible on the same day. Do not take a double dose of
COUMADIN the next day to make up for a missed dose.

Call your healthcare provider right away if you take too much
COUMADIN.

Call your healthcare provider if you are sick with diarrhea, an
infection, or have a fever.

Tell your healthcare provider about any planned surgeries, medical or
dental procedures. Your COUMADIN may have to be stopped for a short time
or you may need your dose adjusted.

Call your healthcare provider right away if you fall or injure
yourself, especially if you hit your head. Your healthcare provider may
need to check you.

What should I avoid while taking COUMADIN?

Do not start, stop, or change any medicine without talking with your
healthcare
provider.

Do not make changes in your diet, such as eating large amounts of
green, leafy
vegetables.

Do not change your weight by dieting, without first checking with your
healthcare provider.

Avoid drinking alcohol.

Do not do any activity or sport that may cause a serious injury.

What are the possible side effects of COUMADIN?

COUMADIN is very important for your health, but it can cause serious
and lifethreatening bleeding problems. See "What is the most important
information I should know about COUMADIN?"

Serious side effects of COUMADIN also include:

death of skin tissue (skin necrosis or gangrene). This can happen soon
after starting COUMADIN. It happens because blood clots form and block
blood flow to an area of your body. Call your healthcare provider right
away if you have
pain, color, or temperature change to any area of your body. You may
need
medical care right away to prevent death or loss (amputation) of your
affected
body part.

"purple toes syndrome." Call your healthcare provider right away if you
have
pain in your toes and they look purple in color or dark in color.

Other side effects with COUMADIN include allergic reactions, liver
problems, low blood pressure, swelling, low red blood cells, paleness,
fever, and rash. Call your healthcare provider if you have any side
effect that bothers you.

These are not all of the side effects of COUMADIN. For more
information, ask your healthcare provider or pharmacist.

How should I store COUMADIN?

Store COUMADIN at room temperature between 59° and 86° F. Protect from
light.

Keep COUMADIN and all medicines out of the reach of children.

General Information about COUMADIN

Medicines are sometimes prescribed for purposes not mentioned in a
Medication Guide.  Do not use COUMADIN for a condition for which it was
not prescribed. Do not give COUMADIN to other people, even if they have
the same condition. It may harm them.

This Medication Guide summarizes the most important information about
COUMADIN.  If you would like more information, talk with your healthcare
provider. You can ask your healthcare provider or pharmacist for
information about COUMADIN that was written for healthcare
professionals.

If you would like more information, call 1-800-321-1335.

Rx only

COUMADIN is distributed by:
Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA
COUMADIN is a registered trademark of Bristol-Myers Squibb Pharma
Company.  COUMADIN (Warfarin Sodium), the COUMADIN color logo, COLORS OF
COUMADIN, and the color and configuration of COUMADIN tablets are
trademarks of Bristol-Myers Squibb Pharma Company.

**The brands listed (other than COUMADIN) are registered trademarks of
their
respective owners and are not trademarks of Bristol-Myers Squibb
Company.

This Medication Guide has been approved by the U.S. Food and Drug
Administration.
-- 
Kathrynne Holden, MS, RD < fivestar at nutritionucanlivewith.com >
"Ask the Parkinson Dietitian"  http://www.parkinson.org/
"Eat well, stay well with Parkinson's disease"
"Parkinson's disease: Guidelines for Medical Nutrition Therapy"
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