In 2006, a new class of birth-control pills was ushered into the spotlight when the FDA approved Yaz. Yaz, along with other pills such as Yasmin, Ocella and Beyaz, contains drospirenone, a new generation of synthetic progesterone. Yaz also contains ethinyl estradiol, the synthetic estrogen found in most birth-control pills.
Yaz and similar pills were hailed as the “ultimate” in birth control solutions, as they were intended not just to prevent pregnancy but also to fight acne and curb the symptoms of severe premenstrual syndrome (PMS). Unfortunately, the makers of Yaz may not only have overstated its benefits, but the drugs also have some serious complications, including an increased risk of blood clots.
If you or someone you love developed a blood clot or other complications from using Yaz, Yasmin, Ocella or Beyaz, you could be entitled to compensation. The dangerous drug attorneys at Roberts & Roberts are currently reviewing claims from women who have been harmed while using these birth-control pills.
About Yaz and Related Birth-Control Pills
Drospirenone is considered a new generation of synthetic progesterone that has anti-androgenic properties.This means that drospirenone works against hormones such as testosterone. Drospirenone is similar to a diuretic called spironolactone and has a 30-hour half-life, resulting in less fluctuation of hormones between cycles.
The unique properties of drospirenone set Yaz and related products apart, and the birth control was marketed as a drug to regulate the menstrual cycle, reduce symptoms of PMS, reduce acne and prevent pregnancy.
Yaz was also unique because it has a 24-day active hormone pill cycle, while most oral birth-control medicines have just a 21-day cycle. This means that instead of taking 21 days of active pills with hormones and seven days of placebo pills, patients on Yaz take 24-days of active hormone pills. This, too, contributes to a reduction in PMS symptoms and reduces hormonal fluctuation.
Yaz became very popular as a result of an aggressive marketing campaign and promises made by Bayer, the manufacturer of the drug. In both 2008 and 2009, Yaz was the best-selling birth-control pill in the U.S. In 2006, more than $2 million worth of Yaz was sold.
Yasmin, Ocella and Beyaz are all very similar to Yaz. Yasmin is the low-dose version of the drug manufactured by Bayer. Beyaz is also manufactured by Bayer. Ocella is a generic version of Yaz manufactured by Barr Laboratories. Teva Pharmaceuticals is responsible for marketing Ocella.
Each of these products has important differences, but the common thread is that they all contain drospirenone. Unfortunately, drospirenone can raise potassium in the body to a dangerous level, and drugs containing this synthetic hormone can have serious side effects.
The Dangers of Yaz, Yasmin, Ocella and Beyaz
Although the benefits of Yaz and related drugs were heavily promoted in marketing efforts, many of the downsides and dangers of the drugs were allegedly downplayed or not disclosed.
Some of the possible dangers of Yaz, Yasmin, Ocella and Beyaz include:
- An increased risk of developing dangerous blood clots called thromboembolism. All women who take oral contraceptives have a somewhat elevated risk of developing blood clots, but those who take Yaz have at least twice the risk of those who take pills containing the hormone levonorgestrel instead.
- Deep vein thrombosis (DVT), or blood clots that form in the legs
- Hyperkalemia, or elevated potassium levels that can cause fatal abnormal heart rhythms
- Pulmonary embolisms, which are blockages that occur in the lungs
- Cardiovascular side effects. The FDA mandated in 2008 that Yaz contain a strong warning label cautioning patients of the dangers of cardiovascular problems. Patients may suffer heart attacks and heart arrhythmias, among other problems.
- Gallbladder disease
- Sudden death
- Upper respiratory infections similar to symptoms from a common cold
- Severe migraines
- Stomach cramps
- Hair loss
- Irregular non-menstrual bleeding
- A reduction in sexual desire
- High blood pressure
- Darkening of skin
- Blood sugar problems
- Severe allergic reactions, including breathing problems and swelling of the lips, face and tongue
- Inflammatory bowel disease
- Breast discharge or the formation of breast lumps.
These complications have very real consequences. More than 100 deaths have already been caused by Yaz, and thousands of other women suffered serious injuries as a result of opting for Yaz or one of the related birth-control pills containing drospirenone.
It turns out that making the switch to Yaz may not have been worth the risk. In 2008, the FDA indicated that Yaz was not effective in treating symptoms of PMS, despite the manufacturers’ claims. Bayer was accused of deceptive ads and paid more than $20 million to produce new television commercials informing the public that Yaz treated PMDD and moderate acne and not regular PMS or mild acne as originally promised.
Some believe that Yaz should have been recalled as studies began to show the dangers of the drug. For example, the FDA’s own study indicated that there was a 74 percent increase in the risk of blood clots in women who take pills containing drospirenone. After launching an advisory committee, however, Yaz remained on the market but had to include a new warning label that explained the increased risk of blood clots
Legal Help for Women Harmed by Yaz, Yasmin, Ocella or Beyaz
Already, more than 10,000 claims have been filed as a result of injuries or complications caused by Yaz, Ocella, Beyaz and Yasmin. In 2012, Bayer settled the cases of 3,490 plaintiffs for a total of $750 million due to Yaz complications. There are many cases that still remain to be settled, and a 2012 report indicated Bayer had set aside approximately $610 million to resolve claims arising from Yaz and related pills.
If you or a loved one suffered injury due to Yaz, Yasmin, Ocella or Beyaz, you could be entitled to compensation. An experienced drug injury attorney at Roberts & Roberts can review your claim and advise you how best to proceed.
For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing. It could mean everything.
- FDA– Warning Letter
- FDA– Yaz MedWatch Safety Information
- Bloomberg– “FDA Cites Blood-Clot Risk Tied to Bayer Birth-Control Pills”
- New York Times– “More Detail on Risk Urged for a Contraceptive Label”
- Bloomberg– “Bayer Judge Postpones First Yaz Trial to Have Cases Mediated”
- ABC News– “FDA to Review Safety Issues Surrounding Leading Birth Control Pill Yaz”