Important Safety Information About Safyral and YASMIN, Including Boxed Warning
Who should not take Safyral or Yasmin?
Do not use SAFYRAL or YASMIN 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 or YASMIN 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 and YASMIN?
SAFYRAL and YASMIN 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 SAFYRAL and YASMIN) 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 or YASMIN.
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 and YASMIN 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 and YASMIN do not protect against HIV infection (AIDS) or other STDs.
Please see full Prescribing Information about SAFYRAL, including boxed warning.
Please see full Prescribing Information about YASMIN, including boxed warning.
BAYER®, the Bayer Cross®, YASMIN®, SAFYRAL®, drsp®, and Aleve® are trademarks of Bayer. All other trademarks are the property of their respective owners.
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.