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Important Safety Information about YAZ Prescribing Information, including Boxed WARNING
YAZ is associated with increased risks of several serious side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. In addition, YAZ contains drospirenone, a different kind of hormone that for some may increase potassium too much. continue reading below
YAZ is associated with increased risks of several serious side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. In addition, YAZ contains drospirenone, a different kind of hormone that for some may increase potassium too much. continue reading below
General safety information
Most healthy women can take birth control pills. But you should not take the Pill if you have certain health conditions.
Talk with your healthcare provider to determine if birth control pills are right for you.
Birth control pills only work if used consistently and correctly. Select one that matches your personality and personal situation.
You should not take YAZ if you:
- Smoke and are over the age of 35*
- A history of heart attack or stroke
- A history of blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- Chest pain (angina pectoris)
- Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
- Unexplained vaginal bleeding (until a diagnosis is reached by your doctor)
- Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the Pill or other hormonal contraceptives
- Liver tumor (benign or cancerous)
- Known or suspected pregnancy
- Are taking prescription medications, on a regular basis, that may not be appropriate with the Pill**
- Heart valve or heart rhythm disorders that may be associated with formation of blood clots
- Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
- Severe high blood pressure
- A need for surgery with prolonged bedrest
- Headaches with neurological symptoms
- Allergy or hypersensitivity to any of the components of YAZ
- Kidney Disease
- Liver Disease
- Adrenal Disease
Side effects
Many women do not experience side effects when they take birth control pills, but some do.
These common symptoms (headaches, nausea, bloating, bleeding between periods, and breast tenderness) are usually mild. As your body adjusts to the Pill, symptoms usually disappear within the first few months. However, if any side effects bother you, contact your healthcare provider.
Additional noncontraceptive health benefits
Learn more about these benefits.
Ask about YAZ
Ask your healthcare provider if YAZ® (drospirenone & ethinyl estradiol) may be right for you.
YAZ contains a different kind of hormone, drsp® (drospirenone), which for some may increase potassium too much. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell you doctor if you are on long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (See Below) should have their potassium levels checked in the first month of taking YAZ.
YAZ is 99% effective at preventing pregnancy when taken as directed. YAZ is also the ONLY birth control pill that's also approved (for women who choose to use the Pill for birth control) to treat the emotional and physical symptoms of PMDD that are severe enough to impact your life.
What's more, in women who are able to and wish to use the Pill for birth control, YAZ may also help treat moderate acne.
YAZ has not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious cluster of symptoms occurring before menstruation. If you or your healthcare provider believes you have PMS, you should only take YAZ if you want to prevent pregnancy; and not for the treatment of PMS.
*
Women who use the Pill should not smoke. Oral contraceptives or birth control pills can be associated with increased risks of several serious adverse events, and do not protect against HIV infection or other STDs. Women, particularly those 35 and over, are strongly advised not to smoke due to the risk of serious cardiovascular side effects, including blood clots, stroke, and heart attack.
**
Other medications may interact with birth control pills. If you are considering the Pill, be sure to tell your healthcare provider about any prescription medications you take. It is also a good idea to mention any nonprescription medications, dietary supplements, herbs, or alternative medicines you take.
Important Safety Information About YAZ®
What is YAZ Prescribed For? YAZ® (drospirenone & ethinyl estradiol) is indicated for:
- The prevention of pregnancy in women who elect to use an oral contraceptive.
- Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
- The effectiveness of YAZ for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
- Treatment of moderate acne vulgaris
- In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.
Who Shouldn't Take Any Oral Contraceptives (OCs)? Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.
In Addition, Who Shouldn't Take YAZ? YAZ contains drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ.
What Drugs May Increase Potassium? NSAIDs-ibuprofen (Motrin®, Advil®), naproxen (Naprosyn®, Aleve®, and others) when taken long-term and daily for arthritis or other diseases or conditions, 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 Risks Involved With Taking Any Oral Contraceptive (OC)? OCs can be associated with an increased risk of several serious cardiovascular side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. OCs do not protect against HIV infection or other STDs.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were reported in all YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, emotional lability, suspicious Papanicolaou smear, weight gain, depression, menstrual disorder, and asthenia.
The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were either unique to each trial type or occurred in only two types of clinical trials included:
- In the contraception trial: leukorrhea, diarrhea, vomiting, vaginitis, flu syndrome, moniliasis, allergic reaction, cystitis, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.
- In the PMDD trials: intermenstrual bleeding, decreased libido, nervousness, menorrhagia, pain in extremity, migraine, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, and acne.
- In the acne trials: metrorrhagia, flu syndrome, menorrhagia, gastroenteritis, tooth disorder, infection, vomiting, pharyngitis, sore throat, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.
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, please see the full prescribing information.
BAYER®, the Bayer Cross®, YAZ®, Aleve®, drsp®, Beyond Birth Control and YAZXpress are trademarks of Bayer. All other trademarks are the property of their respective owners.
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