Yaz, Yasmin, and Ocella are birth control pills used to prevent pregnancy. They work by preventing ovulation and by causing changes in the cervical and uterine lining, making it more difficult for the sperm to fertilize the egg. Yaz was also the first birth control pill approved by the FDA to treat premenstrual dysphoric disorder, or PMDD, which is a controversial condition that is alleged to be a severe form of PMS. In addition, it is approved to treat moderate acne in women over 14 years old.
What makes Yaz, Yasmin, and Ocella so dangerous?
Yaz, Yasmin, and Ocella are dangerous because of the hormones they contain, in particular the form of progestin called drospirenone, or drsp. Drsp is dangerous because it is a diuretic which may elevate the levels of potassium in the blood stream. This condition is known as hyperkalemia. When this occurs, heart rhythms may be interrupted and the flow of blood slowed throughout the body.
The most serious side effects of hyperkalemia are the following:
- DVT—deep vein thrombosis
- Pulmonary embolisms
- Blood clots
- Heart attacks
- Damaged kidneys and gallbladder
- Abnormal heartbeat
It is not only drsp that makes Yaz so dangerous; it is also the way that Bayer has marketed it. Bayer marketed Yaz as more than just birth control—a woman could get contraceptive protection and also reduce acne and control the emotional side effects of her period. Such misleading advertising led Yaz to become the top-selling birth control pill in the United States by 2008, leading to the barrage of problems Bayer is now facing over the drug. The FDA has cited Bayer multiple warnings on its misleading advertising:
- October 2003: The FDA stated that Bayer’s Yasmin advertisements were misleading by suggesting that it was a safer alternative to other birth control pills. It also found that Bayer had minimized the risks and risk factors of Yasmin, such as dangerous side effects from high potassium levels.
- October 2008: The FDA found that Bayer was advertising Yaz for unapproved uses, including the treatment of PMS symptoms, and all types of acne, when the FDA had only approved it for the treatment of the rare disorder PMDD, and moderate acne. Bayer agreed to run a $20 million advertising campaign to clarify the use and potential side effects of Yaz.
- 2009: The FDA issued a third Yaz warning, finding that the ads “failed to communicate any risk information.” The FDA also found that the makers of Yaz continued to misrepresent the drug’s approved indications. In other words, like the warnings in 2003 and 2008, the FDA again concluded that Yaz was being promoted to treat symptoms it was not approved for.
- 2011: In December, the FDA’s panel of experts rules that the Yaz label must be updated to reflect the higher risk of causing blood clots than other contraceptives.
What are the symptoms of Yaz complications?
The symptoms of hyperkalemia include:
- Muscle weakness
- Tingling sensations
The symptoms of blood clots include:
- Persistent leg pain
- Severe chest pain
- Sudden shortness of breath
What have studies revealed about Yaz?
There have been numerous studies on the risks of Yaz. A Danish study of 1.3 million women revealed that drsp-containing contraceptives resulted in a six-fold increase in deep vein thrombosis, which is the formation of clots in the lower leg or thigh that can break loose and travel to the lungs. This can be compared to the three-fold increase that results from traditional contraceptive use. This study was published in BMJ (formerly the British Medical Journal).
What has the FDA done about Yaz side effects?
The FDA has issued numerous warning letters to Bayer, as stated above. In addition, in 2011, the FDA required Bayer to change its label to reflect the elevated risks that Yaz poses. The new label now warns doctors and patients of the increased risk of venous thromboembolism, and that certain women will be at an increased risk for pancreatitis while on Yaz.
Contact a Yaz Attorney at Kirkendall Dwyer LLP Today
If you have suffered injury while using Yaz, Yasmin, or Ocella, you are likely entitled to compensation. Only a Yaz attorney can consider the facts of your case and advise you as to what is the best way to proceed. Contact us today for your free consultation.
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