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)
- Beyaz is 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?
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.
BAYER®, the Bayer Cross®, Beyaz®, drsp®, and Aleve® are trademarks of Bayer.
All other trademarks are the property of their respective owners.
Please see full Prescribing Information about Beyaz, including boxed warning.
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.