Beyaz Lawsuit

Beyaz is an oral contraceptive approved by the FDA in 2010, an estrogen/progestin combination that also contains folate (0.451 mg of levomefolate calcium). It is a “fourth generation” form of birth control that contains drospirenone, a new type of synthetic progestin. Drospirenone has been linked to potentially deadly side effects, including blood clots, pulmonary embolism (PE), heart attack, stroke, and death.

What is Beyaz?

Beyaz is a new type of oral contraceptive that contains drospirenone, a synthetic form of the female sex hormone progestin. Beyaz belongs to the “fourth generation” of birth control pills that contains drospirenone. Other contraceptives in this class include Yaz, Yasmin, Ocella, Gianvi, Loryna, Zarah, Safyral, and Syeda.

Is Beyaz different from Yaz?

Beyaz is essentially the same contraceptive as Yaz, but with added folate, a dietary supplement. Beyaz is the first FDA-approved contraceptive to also include a supplement – the vitamin in it is called levomefolate calcium, which is a metabolite of folic acid. It is a water-soluble B-vitamin, and it helps the body maintain and produce new cells. The FDA recommends that women of childbearing age supplement their diet with folate, because severe neural tube defects (such as spina bifida) have been associated with low folate levels in women.

Beyaz and Yaz are both manufactured by Bayer HealthCare Pharmaceuticals Inc. Both medications contain the same doses of active progestin/estrogen: 3 mg of synthetic progestin (drospirenone), and 0.02 mg of synthetic estrogen (ethinyl estradiol).

Beyaz and Yaz are approved to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD), and treat moderate acne in women who are at least 14 years old. Beyaz and Yaz are not approved to treat PMS or severe acne.

What is the problem with Beyaz?

All birth control pills increase a woman’s risk of blood clots. New birth control pills that contain drospirenone, however, have significantly greater side effects than other birth control pills already on the market. Five new studies have provided ample evidence linking drospirenone to serious, life-threatening blood clots.

Non-FDA studies:

• In 2009, two independent studies found that a woman may be twice as likely to develop a blood clot compared to women using other forms of birth control.
• In 2011, two additional studies published in the British Medical Journal, found similar results. They found that a woman who takes a drospirenone-containing contraceptive may be up to three times more likely to develop a blood clot.
• In November 2011, a massive Israeli study followed 329,995 women taking a drospirenone-containing contraceptive. They found that the risk of blood clots may be more than 40% higher, compared with women who take non-drospirenone contraceptives.

FDA Study & Safety Announcements

In October 2011, the FDA announced the preliminary results of its own study. After following nearly 800,000 women, they found that women have at least a 1.5-fold increased chance of developing a blood clot after using drospirenone-containing birth control, such as Beyaz. The risk of developing blood clots is greatest for women in their first year of taking Beyaz.

Side Effects of Beyaz

Drospirenone increases the amount of potassium in a woman’s bloodstream. This can lead to the formation of blood clots in the extremities, in a side effect known as Deep Vein Thrombosis (DVT). When a person has DVT, blood blots form in the large arteries, usually in the legs. If these blood clots break loose and travel through the bloodstream, this is called an embolism. Embolisms are extremely dangerous. If they travel to the lungs, heart, brain, or other organs, they may become stuck in the arteries that supply oxygenated blood to these organs. This is called a stroke. During a stroke, the organs are starved of oxygen, and they may die. A Pulmonary embolism (PE) is when an embolism blocks the supply of blood to the lungs. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.

If you are taking Beyaz, it is essential that you know the warning signs of DVT. Symptoms may include swelling, pain in the extremities, a “tingling” feeling, slurred speech, or blurry vision. Contact an emergency physician immediately if you suspect that you have a blood clot.

Other side effects:

The most common adverse side effects for Beyaz are expected to be the same as those for Yaz. These include irregular uterine bleeding, nausea, breast tenderness, and headaches. More serious side effects include liver disease and gallbladder disease. Serious side effects are exacerbated by smoking cigarettes, so the FDA recommends that women who are over 35 years old should not take Beyaz if they smoke cigarettes.