Safyral Venous Thromboembolism (VTE) Lawsuit

Safyral VTE

Many women have been seriously injured or killed from side effects of Safyral (drospirenone / ethinyl estradiol). Safyral is a birth control pill that combines hormones with 0.451-mg of folate, a dietary supplement that reduces the risk of neural tube birth defects. Though it seems counter-intuitive for a contraceptive to have an anti-birth defect ingredient, experts know that approximately 9 out of 100 women who do not use Safyral correctly will get pregnant.

The problem with Safyral regards drospirenone, a “fourth generation” progestin that studies have associated with as much as three-fold higher risk of blood clots. The risk is greatest for women who are over 35, smoke, have diabetes, and are overweight, but even women with no risk factors can have a VTE after using Safyral.

What is a Venous Thromboembolism (VTE)?

A Venous Thromboembolism (VTE) begins with the formation of a blood clot. Normally, blood clots only form when there is an injury. The clot is designed to clog vessels and stop life-threatening bleeding. The problem with Safyral is that the hormones in this contraceptive increase the likelihood that a blood clot will develop when there is no injury. The blood clot (comprised of red blood cells, platelets, leukocytes, and fibrin) grows along the walls of vessels. The condition is called Deep Vein Thrombosis (DVT), and typically affects veins in the calf, thigh, pelvis, or arm. The DVT clot tends to grow until it is large enough that it breaks loose and travels in the bloodstream. Veins carry blood to the heart, and the heart pumps this blood into the lungs to receive oxygen. Unfortunately, the blood clot gets stuck inside the lungs, because the blood vessels get very small. This is called a pulmonary embolism (PE).

Many life-threatening complications can occur when a Safyral VTE occurs. One is that the blood clot will severely damage lung tissue. Another risk is that it will severely damage the heart. The heart muscle may be forced to generate very high blood pressure to force blood into the lungs when there is a clot in the way. If the heart muscle is not strong enough, it may fail, leading to cardiac arrest and death.

Signs & Symptoms of a Safyral VTE

Safyral VTE events may not have any symptoms in their early stages. Blood clots are notoriously under-diagnosed, because they cause relatively benign symptoms. Even women who are in the early stages of a VTE may have no idea they are in danger. When a VTE does have symptoms, they may begin as symptoms of DVT and then progress to include symptoms of a PE. These symptoms may include:

• Symptoms in the arms or legs: Pain, tenderness, swelling, discoloration of the skin (redness), warmth in the affected area, dilated veins, coolness in the fingers or toes, decreased circulation to the extremities
• Sweating
• Chest pain or discomfort, which may be just on one side of the body
• Respiratory distress, rapid breathing, shortness of breath
• Rapid pulse, “galloping” heart rhythm
• Feeling weak, tired, or faint
• Losing consciousness
• Coughing, which may produce blood
• Fever
• Anxiety, feeling like something is very wrong

Treatment & Prognosis

Delayed treatment and lack of diagnosis increases the risk of death. Approximately 2-8% of treated VTEs cause death, but this rate increases to 30% when the condition is not diagnosed. Treatment is most effective when a doctor can administer aggressive clot-dissolving medications before the a large clot causes a serious pulmonary embolism. If the patient is suffering from a major pulmonary embolism, it may be necessary for a surgeon to remove the clot and restore circulation.

When a blood clot causes severe damage to veins, Post-Thrombotic Syndrome may occur. This involves transient symptoms, including pain, tingling, and swelling, as well as permanent symptoms, such as varicose veins.