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Wednesday, February 6, 2013
Yaz Birth Control
Although many women started taking Yaz to improve their menstrual cycles, they learned that the everyday side effects of the drug created more problems than they thought.
Even though the mild to moderate side effects from Yaz can range from slight cramping to moderate nausea, this drug is also known for its severe and sometimes debilitating side effects that include migraine headaches, uncontrollable uterine bleeding and kidney disorders.
Yaz, Yasmin and Ocella are different from other birth control pills because they contain a new generation of synthetic progesterone called drospirenone, which is closely related to spironolactone, a diuretic. Drospirenone also has anti-androgenic properties, which means it works against testosterone and other hormones. It also contains synthetic estrogen, similar to most birth control pills.
Yaz is the only pill with 24 active pills that include the hormones and four inactive pills. This gives the patient an increased dose of hormones through the month. Most birth control pills include seven inactive pills.
Yaz is also known to put women at a higher risk of hypertension (high blood pressure), blood clots, liver function disturbances, liver tumors, anaphylactic reactions, changes in glucose levels that can lead to diabetes and to worsen lupus.
Yaz side effects are wide ranging, from upper respiratory infections, similar to that seen in the common cold, to high potassium levels. Researchers also warn that the drug can cause headaches, some as severe as migraines, vaginal yeast infections and unusual vaginal discharge.
Yaz has also been found to cause irregular non-menstrual bleeding, stomach cramps, hair loss and weight gain. Yaz is also known to cause acne, less sexual desire, darkening of the skin on the face, high blood sugar and problems tolerating contact lenses.
More severe side effects from Yaz include anaphylactic reactions, including itching, hives, difficulty breathing and face, lips, tongue swelling. The drug’s side effects also include breast lumps or discharge, a change in the amount of urine processed, fainting, arm and leg numbness, irregular heart beat and inflammatory bowel disease.
Patients with preexisting renal problems and hepatic disease should not take Yaz because Yaz interferes with potassium levels. Serum potassium levels should be checked in women starting Yaz because of the possibility of high potassium levels, called hyperkalemia. Because drospirenone is chemically similar to spironolactone, Yaz should not be used in patients with preexisting kidney problems.
If Yaz is taken with certain drugs and foods, the effects of the pills could be altered. Always check with a doctor before taking the following drugs: ACE inhibitors, antibiotics, heparin, morphine, diuretics, salicylic acid, St. John’s wort and vitamin C. Women who take long-term NSAIDs, such as ibuprofen and naproxen, should not take Yaz. Women who have ever had blood clots in the legs, lungs or eyes should not take Yaz. Yaz is known to increase the risk of severe and deadly blood clots.
Pay close attention to the Yaz side effects and warnings in the drug insert.
Since the drug was released to the market in 2006, the drug’s maker, Bayer, has faced several warning from the FDA. Initially, the FDA fined the company for its slick advertising that proclaimed Yaz to be a cure-all for a multitude of known female menstrual conditions, including premenstrual dysphoric disorder (PMDD) and hormone-induced acne.
Bayer was repeated chastised by the FDA for its advertising practices. Then, in 2009, the FDA sent the company a warning letter regarding the quality of ingredients found during a routine inspection of the manufacturing plant in Germany.
The problems at the plant included dirty equipment and failure to adequately test the final products. At least eight batches of the low-quality birth control pills were sent to the U.S.
The FDA has also been grappling with the onslaught of complaints regarding the drug’s connection to blood clots. In September, the FDA said it “remains concerned” about the drug’s clot risks. Instead of recalling the drug or taking action against the drugmaker, the FDA tossed the decision to one of its advisory committees.
Even though the advisory committee voted to keep the drug on the market, some of the committee members have been criticized for their close ties to Bayer. This questionable relationship between the committee members and Bayer has brought the committee’s actions under suspicion.
Monday, February 4, 2013
Important Facts about Bayer’s Drospirenone-containing Birth Control Pills
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.
Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers
If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights. Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.Saturday, February 2, 2013
What are Beyaz® and YAZ® prescribed for?
What are Beyaz® and YAZ® prescribed for?
For women who choose the Pill for birth control, Beyaz and YAZ are approved to:
For women who choose the Pill for birth control, Beyaz and YAZ are approved to:
- Prevent pregnancy - 99% effective when taken as directed
- Treat premenstrual dysphoric disorder (PMDD)
- 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
Beyaz is 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 use or shortly after stopping
Who should not take Beyaz or YAZ?
Do not use Beyaz 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 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 or YAZ?
Beyaz and YAZ increase the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability. 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 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.
Beyaz and YAZ increase the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability. 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 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, drospirenone is 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 also increase potassium (see below), as you should have a blood test to check your potassium level during the first month of taking Beyaz 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.
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.
The most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting, breast pain/tenderness, fatigue, irritability, decreased libido, weight gain, and mood changes.
Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers
If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights. Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.Sign-up for FREE daily Updates.
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