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Yaz (drospirenone+synthetic ethinyl estradiol) is manufactured by Bayer HealthCare Pharmaceuticals Inc. The drug was introduced in the market in 2006. Bayer advertised 'Yaz' as a new generation pill for birth control that could not only prevent pregnancy but also help women lose weight, cure acne and help with premenstrual moodiness.
Yaz is a birth control pill used to avoid pregnancy. It is also used to treat premenstrual dysphoric disorder (PMDD) and certain types of acne. Yaz contains combination of a new generation of synthetic progesterone called 'drospirenone' (3 mg) and synthetic ethinyl estradiol (0.02 mg). Yaz acts by preventing ovulation, thickening of the mucus in cervix and also by changing uterine lining thereby preventing pregnancies. Yaz contains 24 active pills that include the hormones and four inactive pills. Most birth control pills include seven inactive pills, thus this gives the patient an increased dose of hormones through the month.
The new generation synthetic progesterone 'drospirenone' which is similar in chemical content to diuretic Spironolactone, has been associated with an increase in blood clots, pulmonary embolisms, heart attacks, strokes, gallbladder disease and elevated potassium levels. Drospirenone also has anti-androgenic properties that works against testosterone and other hormones.
Some of the other brand names of similar hormonal compositions by Bayer HealthCare Pharmaceuticals Inc. are Yasmin, Beyaz, Safyral, and Ocella.
Major complications faced till date
Yaz complications include those warned about in packaging (women smokers), however FDA and scientific literature has recently confirmed, the risk of blood clots is higher than originally claimed. Some of the injuries reported by other women and girls (nonsmokers) are:
- Venous thromboembolism
- Deep venous thrombosis
- Pulmonary emboli
- Ischemic stroke
- Arterial thrombotic events
- Hospitalized acute myocardial infarction
- Gall bladder dysfunction followed by surgical removal of the organ
Bayer had been initially warned by FDA for its slick advertising that proclaimed 'Yaz' to be a cure for all known female menstrual conditions, including premenstrual dysphoric disorder (PMDD) and hormone-induced acne.
In 2011, study by FDA showed three times more likely to cause blood clots among users. In December 2011, an Advisory Committee of FDA experts, claimed that the current labeling did not properly or adequately reflect the increased risk. In 2012, FDA decided to change the label for Yaz to warn patients and doctors about the increased risk for developing blood clot. Bayer has paid $402.6 million to settle one category of clot cases for an average of about $212,000 a case, now Bayer will not be settling cases after label changes implemented in 2012. The negotiations about settling of arterial events are still going on.
There still has not been a Yaz recall. The presence of the drug still remains in the market with a warning label change that mentions an increased risk of blood clots for all birth control pill users and not just Yaz.
Evidence to be looked for in potential cases
- Indication of Yaz usage in Medical Records.
- Pharmacy records indicating usage of Yaz.
- Images of Yaz pills.
- Follow up complications and their treatment after initiation of Yaz pills in medical records.
Medical Record Review and claim validation of Yaz case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.