Important Facts about Bayer`s Drospirenone

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Important Facts about Bayer’s Drospirenone-containing Birth Control Pills
Bayer HealthCare is committed to providing customers the latest information regarding the safety of its products.
In cooperation with the Food & Drug Administration (FDA), Bayer has updated the product information for Beyaz, SAFYRAL, YASMIN
and YAZ. We would like to make you aware of new information regarding the risk of blood clots with the use of drospirenone (drsp)
containing birth control pills (like Beyaz, SAFYRAL, YASMIN or YAZ).
Talk with your healthcare provider about your health, personal risk factors and your risk of getting a blood clot before deciding
which birth control pill (also known as “the Pill”) is right for you. If you are currently using Beyaz, SAFYRAL, YASMIN or YAZ, do not
stop taking it without first talking to your healthcare provider.
1. Do Beyaz, SAFYRAL, YASMIN and YAZ carry any greater risk for blood clots (venous thrombosis or VTE), than other birth
control pills?
All users of birth control pills have an increased risk of developing a blood clot compared to non-users. Women who use birth
control pills with drospirenone (like Beyaz, SAFYRAL, YASMIN, or YAZ) may have a higher risk of getting a blood clot. Some
studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for
women who use birth control pills that do not contain drospirenone. Blood clots can be life-threatening or lead to permanent
disability. Talk with your healthcare provider about your health, personal risk factors and your risk of getting a blood clot before
deciding which birth control pill is right for you.
If you are currently using Beyaz, SAFYRAL, YASMIN or YAZ, do not stop taking it without first talking to your healthcare provider.
If you stop taking the Pill and a pregnancy occurs, there is an even higher risk of blood clots during pregnancy than in women
who take birth control pills. (see question #2 below for more information regarding the risk of blood clots).
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. These products do not protect against HIV infection (AIDS) or STDs.
2. How does the risk of blood clots with the use of birth control pills compare to non-use, or to the risk of blood clots during
pregnancy or the first few months after child-birth (postpartum period)?
Users of birth control pills have an increased risk of developing a blood clot compared to non-users. However, a woman’s risk of
blood clots is higher during pregnancy and especially during the first few months after child-birth (see figure below) than that of
a woman on The Pill. To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do
not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure
below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use birth control
pills, for women who use birth control pills, for pregnant women, and for postpartum women in the first 12 weeks after
delivering a baby.
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Likelihood of Developing a Serious Blood Clot
A “COC” is a combination oral contraceptive, which are birth control pills that contains two synthetic female hormones
3. Do all birth control pills carry the risk of blood clots (venous thrombosis or VTE), stroke and heart attack?
Yes, all birth control pills carry the risk of blood clots, stroke and heart attack, especially in women who have other risk factors
such as smoking, obesity, or those women who are over the age of 35. These serious side effects of the Pill are uncommon in
healthy women, and occur infrequently. However, it is important that you be familiar with these serious risks because any of
these conditions can be life-threatening or lead to permanent disability.
Please refer to question #1 regarding risks of blood clots that may be greater in users of Beyaz, SAFYRAL, YASMIN or YAZ.
The Pill may increase a woman’s 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. 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 increased risk of blood clots is highest when you first start taking birth control pills and when you restart the same or
different birth control pills after not using them for a month or more.
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.
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4. How do I know if I’m experiencing a blood clot, heart attack or stroke?
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.
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 or 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 increased risk is highest when you first start taking birth control pills and when
you restart the same or different birth control pills after not using them for a month or more. Users of drospirenone-containing pills
(like Beyaz, SAFYRAL, YASMIN and YAZ) may have a higher risk of blood clots than users of birth control pills that do not contain
drospirenone. Talk to your healthcare provider about your risk of blood clots before deciding which Pill is right for you.
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.
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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?
In the contraception, moderate acne and folate clinical trials, the most common side effects were headache/migraine, menstrual
irregularities, nausea/vomiting and breast pain/tenderness.
In the PMDD clinical trials, the most common side effects were menstrual irregularities, nausea, headache, breast tenderness,
fatigue, irritability, decreased libido, weight gain and mood changes.
What are the most common side effects in SAFYRAL and YASMIN clinical trials?
In the contraception and folate 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.