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Gianvi, a popular oral contraceptive, has been linked to a 75% increased risk of blood clots, which can cause a severe, life-threatening pulmonary embolism. 30% of untreated pulmonary embolisms result in death within hours. They can also cause lifelong disability and permanent damage to lung tissue and other organs.

Overview

Gianvi (ethinyl estradiol / drospirenone) is a new type of birth control pill developed by Teva Pharmaceuticals. The U.S. Food and Drug Administration (FDA) approved Gianvi in 2010 as a generic version of Yaz. Though Gianvi and Yaz are manufactured by different companies, they are essentially the same medication. The FDA has approved Gianvi to prevent pregnancy, treat mild acne, and symptoms of Premenstrual Dysphoric Disorder (PMDD), a severe type of Premenstrual Syndrome (PMS).

Gianvi is a combination of two active drugs:

  • Ethinyl estradiol (0.02 milligrams): This is a synthetic substance that mimics estrogen, a normal female reproductive hormone. Ethinyl estradiol was initially sold in the U.S. in the 1940s, and it has a long history of safe use with very few side effects.
  • Drospirenone (0.3 milligrams): This is a synthetic substance that mimics progestin, a normal female reproductive hormone. Drospirenone has only been used in medicine since it was introduced in Yaz in the mid-2000s. New research has linked drospirenone to a higher risk of developing blood clots, when compared to older versions of synthetic progestin.

What is the problem with Gianvi?

The controversy surrounding Gianvi and other “fourth generation” birth control pills comes from just one ingredient: drospirenone. Several studies have found that women who take a birth control pill containing drospirenone are more likely to develop blood clots, compared to other types of synthetic progestin, such as levonorgestrel.

How much greater is the risk? With older versions of synthetic progestin, it was estimated that around 4-6 women per 10,000 taking the drug would develop a blood clot. Because all types of synthetic progestin increase a woman’s risk of developing a blood clot, it was expected that drospirenone would also have this side effect in comparable amounts. However, after drospirenone became the most popular synthetic progestin, evidence emerged that the risk of developing a blood clot was actually higher — around 10 women per 10,000 taking a contraceptive containing drospirenone.

Gianvi and Pulmonary Embolisms

One side effect of Gianvi is a condition called Deep Vein Thrombosis (DVT), which occurs when blood clots form in the large veins or arteries in the body, usually in the limbs. In some women, the drospirenone in Gianvi significantly increases potassium levels in the bloodstream. The blood is designed to clot when exposed to certain substances, and high levels of potassium are linked to high blood pressure and the formation of blood clots. With DVT, blood clots usually form in the legs, though they may also form in the large arteries in the arms or in the pelvis. DVT is life-threatening, because a blood clot can suddenly break free, becoming an “embolism.”

Blood clots from DVT are the leading cause of pulmonary embolisms or a “pulmonary embolus.” This life-threatening condition occurs when a blood clot travels to the arteries that supply oxygen-rich blood to the lungs. Like every organ in the body, the cells in lungs tissue need to be supplied with fresh, oxygen-rich blood to survive. A blood clot can block the artery supplying this blood to the lung tissue. If the blood clot is small, it may only block blood to a small portion of the lung tissue. If the blood clot is large, it can block most of the blood reaching the lungs. When lung tissue is starved of oxygen, it will begin dying within minutes to hours of the event.

Around 30% of untreated pulmonary embolisms result in death, typically within a few hours of the event. Other cases result in permanent damage to the lung tissue, resulting in lifelong disability or complications.

Signs & Symptoms of a Pulmonary Embolism

If you take Gianvi, it is important to recognize the symptoms of a blood clot and a pulmonary embolism. If you suspect that you have developed this life-threatening condition, do not hesitate to seek emergency attention. Call 911 immediately.

Symptoms may appear gradually, but they typically appear suddenly. The classic warning signs are:

  • Suddenly feeling short of breath. A person suffering from a pulmonary embolism will begin breathing rapidly. It may occur during periods of physical activity, but can also occur during periods of rest. If it occurs while exercising, it typically does not resolve when the person rests.
  • Chest pain. This can be sudden, sharp bursts of pain that resemble a heart attack. The pain is usually located under the breastbone, only on one side of the chest, but can occur on both sides if there is a double pulmonary embolism.
  • Cough. Sudden coughing, or wheezing. The person may begin to cough up blood, or mucous streaked with blood.

Other symptoms may include:

  • Anxiety
  • Sweating
  • Leg pain, swelling in one leg, redness, and tenderness, indicating that a blood clot has formed
  • Changes in heart-rate, rapid heartbeat, irregular beat
  • Weakness, fatigue
  • Clammy or bluish-colored skin, due to a lack of oxygen (called “cyanosis”)
  • Light-headedness, dizziness, fainting

 

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