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Gianvi Venous Thromboembolism (VTE) Lawsuit


Venous Thromboembolism (VTE) begins when blood clots form in the large veins in the extremities (called “Deep Vein Thrombosis”), break loose, and become trapped in the lungs, in a life-threatening condition known as a Pulmonary Embolism. Around 30% of people who have an untreated pulmonary embolism will die.

Gianvi Overview

Gianvi is a once-daily, oral birth control pill. It is created by a joint project between Bayer and the generic drug companies Teva Pharmaceuticals and Barr Laboratories. In 2010, the U.S. Food and Drug Administration (FDA) approved Gianvi to prevent pregnancy, reduce mild acne, and treat symptoms of a rare condition called Premenstrual Dysphoric Disorder (PMDD).

The Gianvi regimen consists of 24 “active” pills and 4 “inactive” pills. The inactive pills help a woman stay in the habit of taking a birth control pill every day, and the active pills prevent pregnancy with synthetic hormones, including:

  • 3 milligrams drospirenone (synthetic progestin)
  • 0.02 milligrams ethinyl estradiol (synthetic estrogen)

Gianvi is a very similar medication to Yaz birth control. In fact, Gianvi is the generic version of Yaz, and many women who were initially prescribed Yaz switched to Gianvi because it was cheaper and equally effective. Gianvi and Yaz have the same amount of active ingredients. Both medications also carry the same risks, benefits, and side effects, including VTE.

Gianvi and Venous Thromboembolism (VTE)

The controversy regarding Gianvi stems from one ingredient: drospirenone. This ingredient was developed by the pharmaceutical company Bayer, and was first incorporated into Yaz and Yasmin birth control pills in the mid-2000s. Drospirenone is a new type of synthetic progestin, a female sex hormone. Though all birth control pills containing progestin slightly increase a woman’s risk of forming blood clots, there is a growing volume of data showing that drospirenone carries a slightly higher risk of blood clots compared to older types of synthetic progestin.

How much higher is the risk? The FDA estimates that a woman taking a drospirenone-containing birth control pill, such as Gianvi, is 75% more likely to develop a blood clots. In effect, the risk of blood clots increases from 4-6 women per 10,000, to 10 women per 10,000 taking a birth control pill.

These blood clots most often form in the deep veins in the legs, in a condition called Deep Vein Thrombosis. Blood clots are extremely dangerous, because they have a tendency to break free from their origin. A blood clot that travels through the bloodstream is called an embolism, and if an embolism becomes stuck in the vessels supplying blood to the heart, brain, or lungs, it can cause heart attack, stroke, pulmonary embolism, and death.

What is a Venous Thromboembolism (VTE)?

Venous thromboembolism is the name of a disease that combines two conditions:

  • Deep Vein Thrombosis (DVT): This occurs when blood clots form in veins deep inside the body. They most commonly form in the legs or the pelvis, but can also form in the arms.
  • Pulmonary Embolism (PE): If a blood clot breaks free, it may travel in the bloodstream to the heart. The heart pumps all blood into the lungs, but if this blood contains a blood clot, the clot may become trapped in the small blood vessels in the lungs. This blocks the supply of blood to part of the lungs, causing lung tissue to die

Signs and Symptoms of a Venous Thromboembolism (VTE)

The signs and symptoms of VTE should not be ignored. This is a life-threatening condition that can quickly lead to death if untreated. It is estimated that 30% of people with VTE will die from the condition. It is essential to seek emergency treatment immediately.

The first symptoms of VTE typically include, but are not limited to:

  • Chest Pain: Usually under the breastbone or on one side of the chest. Pain can be sharp, stabbing, burning, aching, dull, or throbbing sensation. It may get worse with deep breathing, coughing, eating, or bending.
  • Sudden cough, may be bloody
  • Rapid breathing
  • Rapid heart rate
  • Shortness of breath, begins suddenly
  • Anxiety, feeling something serious is wrong
  • Bluish-purple discoloration to skin, lips, or nails (cyanosis)
  • Clammy, cold skin
  • Dizziness, fainting, light-headedness
  • Leg pain
  • Discoloration of one leg
  • Low blood pressure
  • Sweating
  • Wheezing

Other Gianvi Side Effects

Gianvi side effects include, but are not limited to:


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