Important Facts about Bayer Birth Control Pills To learn more click

							 
 
                                                                             
                                                                                                                       
 
                                                           
                                Important Facts about Bayer’s Birth Control Pills
                     To learn more, click here to read the FDA Drug Safety Communication
You may be receiving information causing you concern if you’re one of the many women who use Bayer’s birth
control pills containing drospirenone.

If you are currently using one of these pills, do not stop taking it without first talking to your healthcare provider.

Bayer continues to stand behind its products, and believes that the Pill is an important birth control option for
women. When it comes to your health, especially your birth control, Bayer believes it’s important for you to
have the facts. Learn more and talk to your healthcare provider.

1. Does the Pill carry the risk of blood clots (venous thrombosis or VTE), stroke and heart attack?
   Yes, all birth control pills, including Beyaz, SAFYRAL YASMIN and YAZ, carry the risk of blood clots, stroke
   and heart attack. These serious side effects of the Pill occur very infrequently, especially if you are young
   and in good health. However, it is important that you are familiar with these serious risks because any of
   these conditions can be life-threatening.

    The Pill may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain)
    and heart attacks (blockage of blood vessels in the heart). Blood clots and blockage of blood vessels are
    the most serious side effects of taking birth control pills. In particular, a clot in the legs (deep vein
    thrombosis), can cause pain and swelling, and a clot that travels to the lungs (pulmonary embolism) can
    cause sudden blocking of the vessel carrying blood to the lungs. The risk of blood clots is highest during
    the first year of use. This risk is greatest when first starting the Pill and when restarting the same or a
    different Pill after a 4 week or greater break. It’s important to note, however, that the incidence of blood
    clots associated with pregnancy is as much or more than the risk associated with the use of birth control
    pills.

    Do not use these products if you smoke and are over the age of 35. Smoking increases your risk of serious
    side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This
    risk increases with age and the number of cigarettes smoked.

    Some women should not use the Pill including women who have or have had blood clots, certain cancers, a
    history of heart attack or stroke, as well as those who are or may be pregnant.

    Talk to your healthcare provider before taking any birth control pill to be sure that it is right for you.

    Please see additional Important Safety information about Beyaz, SAFYRAL, YASMIN and YAZ, including
    boxed warnings, below.

2. Do Beyaz, SAFYRAL, YASMIN and YAZ carry any greater risk for blood clots (VTE), than other birth control
   pills?
   Bayer believes based on our assessment of currently available information, that the risk of developing
   blood clots is comparable among birth control pills. Because patient safety is Bayer’s top priority, we
   continue to conduct research on our birth control pills to monitor safety, even after the products are
   approved for use.
    Bayer is aware that there are studies both concluding that the risk of developing blood clots is comparable
    among birth control pills and other studies concluding that drospirenone-containing birth control pills
    carry an increased risk of blood clots compared to certain other birth control pills. A recent posting on the
    FDA website presents results of an FDA-funded study suggesting an increase in the risk of blood clots for
    women who use drospirenone-containing birth control pills compared to users of other hormonal
    contraceptives. Further information about the FDA study is available here.

    Bayer is working closely with the FDA to evaluate this information and remains committed to keeping
    patients informed about the benefits and risks associated with these products. Talk to your healthcare
    provider if you have any questions about using Bayer's birth control pills.

    Refer to Question #1 for additional information regarding risk of blood clots with the use of birth control
    pills including Beyaz, SAFYRAL, YASMIN and YAZ.


    Please see additional Important Safety Information about Beyaz, SAFYRAL, YASMIN and YAZ including
    boxed warnings, below.

3. Are Beyaz, SAFYRAL, YASMIN and YAZ safe?
   Bayer’s birth control pills are safe and effective when used as directed in accordance with product labeling
   and good clinical practice. Healthcare providers prescribe the Pill following a comprehensive evaluation of
   the risks and benefits for each individual woman. It is important to talk to your healthcare provider who
   can determine which birth control method is most appropriate for you based on your personal medical
   history and overall health profile. But you should remember that the Pill is not right for everyone.

    Do not use Beyaz, SAFYRAL, YASMIN and YAZ if you have kidney, liver, or adrenal disease because this
    could cause serious heart and health problems, or if you have or have had blood clots, certain cancers,
    history of heart attack or stroke, or if you are or may be pregnant. These products do not protect against
    HIV infection (AIDS) or STDs.

4. How do I know if I’m experiencing a blood clot, heart attack or stroke?
   These serious side effects of the Pill occur very infrequently, especially if you are young and in good health.
   However, the following are possible warning signals:

    Pain and swelling in the calf could indicate a possible clot in the leg. Sharp chest pain, coughing of blood or
    sudden shortness of breath could be an indication of a possible clot in the lung. If you experience crushing
    chest pain or heaviness in the chest, this could indicate a possible heart attack. In addition, sudden severe
    headache or vomiting, dizziness or fainting, disturbances of vision (sudden blindness, partial or complete)
    or speech (trouble speaking), weakness, or numbness in an arm or leg could be symptoms of a possible
    stroke.

    If any of these serious side effects occur while taking birth control pills, call your healthcare provider
    immediately.

Please see additional Important Safety Information about Beyaz, SAFYRAL, YASMIN and YAZ including boxed
warnings, below.
What are Beyaz®, SAFYRAL®, YASMIN® and YAZ® prescribed for?
For women who choose the Pill for birth control, Beyaz, SAFYRAL, YASMIN and YAZ are approved to:

       Prevent pregnancy - 99% effective when taken as directed

Beyaz and SAFYRAL are also approved for women who choose the Pill for birth control to:

       Provide a daily dose of folate supplementation, which is recommended for women in their
        reproductive years. Folate lowers the risk of having rare neural tube birth defects in a pregnancy
        occurring during Beyaz or SAFYRAL use or shortly after stopping

In addition, Beyaz and YAZ are also approved for women who choose the Pill for birth control to:

       Treat premenstrual dysphoric disorder (PMDD)
            o Beyaz and YAZ are not approved to treat Premenstrual Syndrome (PMS), a less serious set of
                symptoms occurring before your period

       Treat moderate acne in women at least 14 years of age

Who should not take Beyaz, SAFYRAL, YASMIN or YAZ?
Do not use Beyaz, SAFYRAL, YASMIN or YAZ if you smoke and are over age 35. Smoking increases your risk of
serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack.
This risk increases with age and number of cigarettes smoked.

Do not use Beyaz, SAFYRAL, YASMIN or YAZ if you have kidney, liver, or adrenal disease because this could
cause serious heart and health problems, or if you have or have had blood clots, certain cancers, history of
heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking Beyaz, SAFYRAL, YASMIN and YAZ?
Beyaz, SAFYRAL, YASMIN and YAZ increase the risk of serious conditions including blood clots, stroke, and
heart attack. The risk of blood clots is highest during the first year of use. This risk is greatest when first
starting the Pill and when restarting the same or a different Pill after a 4 week or greater break.

In addition, Beyaz, SAFYRAL, YASMIN and YAZ each contain drospirenone, a different kind of hormone that for
some may increase potassium too much. Consult your healthcare provider if you are on daily long-term
treatment for a chronic condition with medications that may increase potassium (see below), as you should
have a blood test to check your potassium level during the first month of taking Beyaz, SAFYRAL, YASMIN or
YAZ.

Call your healthcare provider right away if you have:

       Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in
        your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm
        or leg, or trouble speaking; yellowing of the skin or eyes
What medications may increase potassium?
NSAIDs—ibuprofen (Motrin®, Advil®), naproxen (Aleve® and others) when taken long-term and daily for arthritis
or other problems, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE
inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®,
Avapro®, and others), aldosterone antagonists, and heparin.

What are the most common side effects in Beyaz and YAZ clinical trials?
The most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting, breast
pain/tenderness, fatigue, irritability, decreased libido, weight gain and mood changes.

What are the most common side effects in SAFYRAL and YASMIN clinical trials?
The most common side effects were premenstrual syndrome, headache/migraine, breast
pain/tenderness/discomfort, nausea/vomiting, mood changes and abdominal pain/discomfort/tenderness.

Beyaz, SAFYRAL, YASMIN and YAZ do not protect against HIV infection (AIDS) or other STDs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information for Beyaz, please see the full Prescribing Information.
For important risk and use information for SAFYRAL, please see the full Prescribing Information.
For important risk and use information for YASMIN, please see the full Prescribing Information.
For important risk and use information for YAZ, please see the full Prescribing Information.

BAYER®, the Bayer Cross®, Beyaz®, SAFYRAL®, YASMIN®, YAZ®, Aleve® and drsp® are trademarks of Bayer. All
other trademarks are the property of their respective owners.