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Birth Control Pill YAZ Is Subject Of Ongoing Safety Study

YAZ (3 mg drospirenone/20 mcg ethinyl estradiol) is an oral contraceptive (OC) which is the first 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.

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.

The study was funded with an unrestricted grant from Bayer Schering Pharma AG. Dr. Dinger has disclosed no relevant financial relationships.


Under routine medical conditions, a 24-day regimen of drospirenone and ethinyl estradiol (DRSP/EE) has higher contraceptive effectiveness than a 21-day regimen of DRSP/EE or other progestin, or a 24-day regimen of norethindrone acetate and ethinyl estradiol (NETA/EE).

These preliminary 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.

The INAS study was designed as a controlled, prospective, noninterventional cohort study with active surveillance in the United States and 5 European countries. Participants were recruited through an international network of gynecologists.

“At the end of the study, they will have more than 80,000 OC users and more than 150,000 women-years of exposure,” said Dr. Dinger.

Study cohorts are divided into 24/4 DRSP/EE, 21/7 DRSP/EE, and OCs containing other progestins. The study period is 2005 to 2012.

Of the 52,219 women who have been recruited, 10,302 women are enrolled in the 24/4 DRSP/EE cohort, 3,982 in the 21/7 DRSP/EE cohort, and 37,935 in the cohort of other OCs. This represents a total of 49,298 women-years, and there have been a total of 1126 unintended pregnancies so far.

The study was funded with an unrestricted grant from Bayer Schering Pharma AG. Dr. Dinger has disclosed no relevant financial relationships.

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

The Dr. Shezad Malik Law Firm is currently evaluating and accepting Yaz, Yasmin and Ocella Side Effect cases.

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