Birth Control Pill YAZ Being Reviewed For Increased Risk Of Blood Clots And Serious Side Effects

This "Fourth Generation" DRSP / EE Pill Oral Contraceptive Has Been Associated With Deep Vein Thrombosis, Pulmonary Embolism, Heart Attacks, And Strokes

YAZ (3 mg drospirenone/20 mcg ethinyl estradiol) is the first birth pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP). YAZ was approved by the FDA in March 2006.

As explained below, the FDA apparently has had some concerns about an association between YAZ and deep vein thrombosis (DVT), pulmonary embolism (PE), heart attacks, and strokes.

A study called the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC), which was started in August 2005 and continues to date, is intended to evaluate the risk of those cardiovascular side effects for women who use DRSP/EE birth control pills like YAZ.

According to a May 11, 2009 article, "ACOG 2009: Preliminary Findings Favor 24-Day Regimen of Drospirenone and Ethinyl Estradiol for Contraception", published online by Medscape:

[P]reliminary findings from the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study were presented here at the American College of Obstetricians and Gynecologists (ACOG) 57th Annual Clinical Meeting by Jürgen Dinger, MD, PhD, from the Berlin Center for Epidemiology and Health Research in Germany....

"The INAS study is a transatlantic prospective cohort study that was requested by the [US Food and Drug Administration] to investigate the safety of a 24-day regimen of 3 mg DRSP and 20 µg ethinyl estradiol (24/4 regimen)," Dr. Dinger told the audience. To date, the INAS study has enrolled 52,219 women....

The study's objectives are to compare the cardiovascular safety of the 24/4 regimen of DRSP/EE to established oral contraceptives (OCs) during standard clinical practice (eg, deep venous thrombosis, pulmonary embolism, acute myocardial infarction, stroke); to investigate the incidence of rare serious adverse events associated with the use of 24/4 and established OCs; and to investigate contraceptive failure rates associated with the use of the 24-day and 21-day regimens of DRSP/EE and all other OCs.

If you or someone you know has developed a deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, or stroke while using YAZ, it may have been a YAZ side effect and there is the possibility of getting legal compensation from Bayer for the injury or death.

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