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Safyral Lawsuit


Safyral is a “fourth generation” birth control pill that contains drospirenone (synthetic progestin). It also contains folate, a vitamin supplement intended to prevent neural tube birth defects, such as spina bifida. Recently, drospirenone has been the subject of several studies which linked it to an increase in serious, life-threatening blood clots, strokes, pulmonary embolisms, and death.

What is Safyral?

Safyral is a birth control medication that combines Yasmin with a folate B-vitamin. When taken correctly, fewer than 1 out of 100 women who take Safyral as their primary contraceptive will become pregnant. It is especially effective at preventing pregnancy because it inhibits ovulation (when the ovaries release an egg). In addition, it changes the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation).

Safyral consists of 21 orange tablets, each containing the following active ingredients:

  • 3 mg Drospirenone (synthetic progestin)
  • 0.03 mg Ethinyl estradiol (synthetic estrogen)
  • 0.451 mg levomefolate calcium (folate)

Safyral also contains seven inactive tablets. These help a woman stay in the habit of taking Safyral at the same time every day, which improves her chances of preventing pregnancy.

Several clinical trials have found that folate supplementation can reduce the incidence of neural tube defects (such as spina bifida). Therefore, the Centers for Disease Control and Prevention (CDC) recommends that women of childbearing age consume at least 0.4 mg of supplemental folic acid every day. Safyral contains slightly more than this amount.

Safyral belongs to a new class of birth control pills that contain drospirenone, which is a synthetic form of the female sex hormone progestin. Other birth controls that contain drospirenone are Yaz, Yasmin, Ocella, Beyaz, Gianvi, Zarah, Loryna, and Syeda.

Non-FDA Studies of Drospirenone

All birth control pills increase a woman’s risk of blood clots, but new types of birth control that contain drospirenone increase this risk significantly. Five non-FDA studies have studied the differences between drospirenone-containing birth control and non-drospirenone birth control. The findings have raised alarm.

  • Two studies conducted in 2009 found that women may be twice as likely to develop a blood clot compared to women using other forms of birth control.
  • Additionally, in 2011, the British Medical Journal reported that a woman taking birth control with drospirenone may be up to three times more likely to develop a blood clot.
  • In November 2011, a massive study in Israel found that the risk of blood clots may be more than 40% higher for contraceptives with drospirenone. The researchers studied 329,995 women and compared the incidence of thromboembolic events.

FDA Conducts Study, Issues Safety Warning

The FDA conducted a massive study of nearly 800,000 women who were taking drospirenone-containing contraceptives, such as Safyral. The FDA found that women have at least a 1.5-fold increased chance of developing a blood clot while using this type of birth control. The risk of developing blood clots is greatest for women in their first year.

Serious Side Effects of Safyral

Serious side effects may include blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, gallbladder disease, and cardiovascular events. These risks are increased for women who smoke, particularly if they are over 35 years old. If you are taking Safyral, you should be aware of the symptoms of a blood clot that can cause life-threatening side effects.

Intracranial Hypertnesion

Our lawyers are also investigating the risk of Idiopathic Intracranial Hypertension (IIH) or Pseudotumor Cerebri (PTC). These conditions cause high pressure inside the skull, migraine headaches, and blindness.

Blood Clots

Drospirenone increases potassium in a woman’s bloodstream. High potassium levels may cause the formation of blood clots, particularly in the large arteries in the extremities. This is called Deep Vein Thrombosis (DVT). Symptoms of DVT include pain in the extremity, numbness, swelling, a “tingling” feeling, slurred speech, and blurred vision. If you experience any of these symptoms, or if you suspect that you have a blood clot, contact an emergency physician immediately. Blood clots caused by Safyral can lead to death.

If a blood clot breaks loose and travels though the bloodstream, this is called an embolism. Embolisms are extremely dangerous, because if they travel to a major internal organ and become stuck in the artery, they can block the supply of oxygenated blood to the organ. Serious injury or death can occur very quickly if a blood clot becomes lodged in the heart, lungs, brain, or other major internal organs.

During a Pulmonary embolism (PE), an embolism becomes trapped in the artery leading to the lung. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.

The risk of other side effects is increased for women who smoke, particularly women who are over 35 years old. These side effects may include cardiovascular events, liver disease, uterine bleeding, and gallbladder disease.

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