Beyaz Mirena Natazia Safyral

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Information You Need To Know Message to Healthcare Professionals FDA Link

 

 

Important Safety Information About BEYAZ, Including Boxed Warning

What is Beyaz® prescribed for?
For women who choose the Pill for birth control, Beyaz is approved to:

  • Prevent pregnancy - 99% effective when taken as directed
  • 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 defects in a pregnancy occurring during Beyaz use or shortly after stopping
  • Treat premenstrual dysphoric disorder (PMDD)
  • Treat moderate acne in women at least 14 years of age

Who should not take Beyaz?

Do not use Beyaz 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 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?
Beyaz increases 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) 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.

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 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.

Beyaz does 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.

Please see full Prescribing Information about Beyaz, including boxed warning.

Important Safety Information About Safyral, Including Boxed Warning

What is SAFYRAL® prescribed for?
For women who choose the Pill for birth control, SAFYRAL is approved to:

  • Prevent pregnancy - 99% effective when taken as directed
  • 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 Safyral use or shortly after stopping

Who should not take SAFYRAL?

Do not use SAFYRAL 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 the number of cigarettes smoked.

Do not use SAFYRAL 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, a history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking SAFYRAL?
SAFYRAL increases 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 SAFYRAL) 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 SAFYRAL.

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 SAFYRAL 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.

SAFYRAL does 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.

Please see full Prescribing Information about SAFYRAL, including boxed warning.

IMPORTANT SAFETY INFORMATION ABOUT NATAZIA, Including Boxed Warning

What Is Natazia® prescribed for?
Natazia is a birth control pill approved to prevent pregnancy. Natazia can also be used for the treatment of heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb) in women who decide to use the Pill for birth control.

Natazia has not been studied for pregnancy prevention in women who are obese (body mass index > 30).

Who should not take Natazia?

Do not use Natazia 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 Natazia 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 Natazia?
Natazia increases 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.

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 are the most common side effects in Natazia clinical trials?
The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea/vomiting, acne, mood changes, and weight gain.

Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or cardiovascular disease.

Natazia does 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.

Please see full Prescribing Information about Natazia, including boxed warning.

Important Safety Information About MIRENA

What is MIRENA® prescribed for?
MIRENA is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years. MIRENA also treats heavy periods in women who choose intrauterine contraception.

What important safety information should I know about MIRENA?
Only you and your healthcare provider can decide if MIRENA is right for you. MIRENA is recommended for women who have had a child.

  • Don't use MIRENA if you have a pelvic infection, get infections easily or have certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. If you have persistent pelvic or abdominal pain, see your healthcare provider.
  • MIRENA may attach to or go through the wall of the uterus and cause other problems. If MIRENA comes out, use back-up birth control and call your healthcare provider.
  • Although uncommon, pregnancy while using MIRENA can be life threatening and may result in loss of pregnancy or fertility.
  • Ovarian cysts may occur and usually disappear.
  • Bleeding and spotting may increase in the first few months and continue to be irregular. Periods over time may become shorter, lighter or even stop.

MIRENA does not protect against HIV infection 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.

Please see full Prescribing Information about MIRENA.

BAYER®, the Bayer Cross®, and MIRENA® are trademarks of Bayer. All other trademarks are property of their respective owners.

 

Beyaz

Important Safety Information About BEYAZ, Including Boxed Warning

What is Beyaz® prescribed for?
For women who choose the Pill for birth control, Beyaz is approved to:

  • Prevent pregnancy - 99% effective when taken as directed
  • 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 defects in a pregnancy occurring during Beyaz use or shortly after stopping
  • Treat premenstrual dysphoric disorder (PMDD)
  • Treat moderate acne in women at least 14 years of age

Who should not take Beyaz?

Do not use Beyaz 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 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?
Beyaz increases 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) 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.

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 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.

Beyaz does 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.

Please see full Prescribing Information about Beyaz, including boxed warning.

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Safyral

Important Safety Information About Safyral, Including Boxed Warning

What is SAFYRAL® prescribed for?
For women who choose the Pill for birth control, SAFYRAL is approved to:

  • Prevent pregnancy - 99% effective when taken as directed
  • 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 Safyral use or shortly after stopping

Who should not take SAFYRAL?

Do not use SAFYRAL 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 the number of cigarettes smoked.

Do not use SAFYRAL 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, a history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking SAFYRAL?
SAFYRAL increases 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 SAFYRAL) 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 SAFYRAL.

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 SAFYRAL 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.

SAFYRAL does 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.

Please see full Prescribing Information about SAFYRAL, including boxed warning.

Natazia

IMPORTANT SAFETY INFORMATION ABOUT NATAZIA, Including Boxed Warning

What Is Natazia® prescribed for?
Natazia is a birth control pill approved to prevent pregnancy. Natazia can also be used for the treatment of heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb) in women who decide to use the Pill for birth control.

Natazia has not been studied for pregnancy prevention in women who are obese (body mass index > 30).

Who should not take Natazia?

Do not use Natazia 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 Natazia 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 Natazia?
Natazia increases 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.

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 are the most common side effects in Natazia clinical trials?
The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea/vomiting, acne, mood changes, and weight gain.

Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or cardiovascular disease.

Natazia does 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.

Please see full Prescribing Information about Natazia, including boxed warning.

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Mirena

Important Safety Information About MIRENA

What is MIRENA® prescribed for?
MIRENA is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years. MIRENA also treats heavy periods in women who choose intrauterine contraception.

What important safety information should I know about MIRENA?
Only you and your healthcare provider can decide if MIRENA is right for you. MIRENA is recommended for women who have had a child.

  • Don't use MIRENA if you have a pelvic infection, get infections easily or have certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. If you have persistent pelvic or abdominal pain, see your healthcare provider.
  • MIRENA may attach to or go through the wall of the uterus and cause other problems. If MIRENA comes out, use back-up birth control and call your healthcare provider.
  • Although uncommon, pregnancy while using MIRENA can be life threatening and may result in loss of pregnancy or fertility.
  • Ovarian cysts may occur and usually disappear.
  • Bleeding and spotting may increase in the first few months and continue to be irregular. Periods over time may become shorter, lighter or even stop.

MIRENA does not protect against HIV infection 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.

Please see full Prescribing Information about MIRENA.

BAYER®, the Bayer Cross®, and MIRENA® are trademarks of Bayer. All other trademarks are property of their respective owners.

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