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.
3. Do all birth control pills carry the risk of blood clots (venous thrombosis or VTE), stroke and heart attack?
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.
