Patients are advised to alert their healthcare provider if they are taking folate supplements.  SAFYRAL is not indicated during pregnancy.  SAFYRAL has 99 percent contraceptive efficacy when used as directed.  If pregnancy occurs during treatment with SAFYRAL, further intake must be stopped.  If a woman discontinues use of SAFYRAL either with the intention of becoming pregnant or if she discontinues due to pregnancy while on the product, she is strongly encouraged to speak with her healthcare provider about taking a multivitamin with folic acid or another folate to maintain recommended folate intake.

SAFYRAL is in a 21/7 day regimen consisting of 21 days of drospirenone 3 mg/ethinyl estradiol 30 mcg with levomefolate calcium 451 mcg (Metafolin?®) followed by seven days of Metafolin only.  SAFYRAL is expected to be available in mid-January 2011 by prescription only.

Women should not use SAFYRAL if they have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if they have or have had blood clots, certain cancers, history of heart attack or stroke, or if they are or may be pregnant.  SAFYRAL increases the risk of serious conditions including blood clots, stroke and heart attack.  Smoking increases these risks, especially in women over 35.  The risk of blood clots is highest during the first year of use.  

In addition, SAFYRAL contains drospirenone, a different kind of hormone that for some may increase potassium too much.  Women should consult with their healthcare provider if they are on daily long-term treatment for a chronic condition with medications that may also increase potassium, as they should have a blood test to check their potassium level during the first month of taking SAFYRAL.

SOURCE Bayer HealthCare Pharmaceuticals, Inc.