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Safyral Pulmonary Embolism Lawsuit


According to the FDA and several recent studies, the risk of developing blood clots and pulmonary embolisms is higher for women taking drospirenone, an ingredient in Safyral. Women who suffer a pulmonary embolism are at risk of having a very large blood clot that completely stops blood flow to the lungs.

Safyral Overview

Safyral is a birth control pill that is essentially Yasmin plus a folate B-vitamin. Like Yasmin, Safyral is sold by the drug company Bayer HealthCare Pharmaceuticals. Yasmin and Safyral both contain the same amounts of synthetic hormones (3-mg drospirenone and 0.03-mg ethinyl estradiol). One difference between the two drugs is that Yasmin was one of the first drospirenone-containing birth control pills, while Safyral is relatively new. The U.S. Food and Drug Administration (FDA) approved Safyral in 2010.

Another major difference is that Safyral contains levomefolate calcium, which is a metabolite of folic acid. After researchers discovered that many serious birth defects were caused be maternal deficiencies of the folate vitamin, the FDA recommended that most women of childbearing age should take a folic acid supplement. It may seem strange that a birth control pill, intended to prevent pregnancy, would also contain an ingredient to reduce the risk of birth defects. However, pregnancy does occasionally occur in women who are taking birth control pills (approximately 1 woman out of 100 will get pregnant while taking birth control).

Safyral and Pulmonary Embolisms

Safyral contains drospirenone. Drospirenone is a “fourth generation” synthetic version of the female reproductive hormone progestin. Nearly all hormonal birth control pills contain progestin, and are associated with an increased risk of blood clots. Recently, the FDA announced that the risk of blood clots with drospirenone is likely higher than for other progestins. The labels on Safyral will be updated accordingly.

The problem with blood clots is that they can cause one of the most severe side effects of Safyral: a pulmonary embolism. When a blood clot forms (usually in the lower leg, during a condition called Deep Vein Thrombosis or DVT), there is a chance that it could travel through the bloodstream and become trapped inside the lungs. This cuts off the blood going to the lungs, and can cause lung tissue to die. In severe cases, pulmonary embolisms cause permanent lung damage, organ failure, disability, or death.

Symptoms of a Safyral Pulmonary Embolism

Sometimes, people who are suffering from a pulmonary embolism do not seek treatment right away because the initial symptoms do not seem life-threatening. Unfortunately, an untreated pulmonary embolism can quickly cause death. The initial symptoms may be caused by small blood clots. However, a large blood clot may suddenly become trapped in the lungs and completely cut off the supply of blood to the lungs. Around 60,000 people die from pulmonary embolisms every year. Any time a pulmonary embolism is suspected, this is an emergency.

The initial symptoms of a venous thromboembolism may be symptoms of DVT. These include pain, swelling, discoloration, and any abnormal sensation in an extremity (almost always the lower leg). These symptoms may indicate the formation of a blood clot. If the blood clot causes a pulmonary embolism, characteristic symptoms include:

  • Sudden shortness of breath with no apparent reason
  • Rapid breathing
  • Pain in the chest (usually on one side) that may get worse when the person breathes deeply, coughs, or moves
  • Coughing, which may produce bloody sputum
  • Faintness, dizziness, loss of consciousness
  • Feeling like something serious is wrong, anxiety, nervousness

Treatment for a Safyral Pulmonary Embolism

Most Safyral pulmonary embolisms are not life-threatening, because they are caused by small blood clots. However, even small blood clots can cause lung tissue damage. It is difficult for the body to dissolve these clots once they are inside the lungs, so a doctor will administer a blood-thinning medication. Usually, this means oral warfarin and intravenous heparin. The blood-thinners prevent blood clots from getting bigger and help prevent more serious injury.

Sometimes, very large blood clots get trapped in large blood vessels in the lungs. They may actually cut off most of the supply of blood to the lungs. Within minutes, lung tissue starts dying, and if the blood clot is not removed, the entire organ will fail. This can cause death. To treat these severe pulmonary embolisms, a surgeon may be forced to use surgery, aggressive clot-busting drugs, or catheter techniques to restore circulation to the lungs.

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