Gianvi Pulmonary Embolism Lawsuit

Around 30% of untreated pulmonary embolisms result in death, usually within the first few hours of the event.

Overview

Gianvi (ethinyl estradiol / drospirenone) is a popular oral contraceptive created by Teva Pharmaceuticals, approved by the U.S. Food and Drug Administration in 2010. It is the generic form of Yaz, and they are essentially the same medication. Many women who were initially using Yaz switched to Gianvi when it became available as a cheaper, equally effective alternative.

Gianvi contains the following ingredients:

• Ethinyl estradiol, 0.02 milligrams: Synthetic estrogen, first sold in the 1940s, used in medicine with very few side effects
• Drospirenone, 0.3 milligrams: Synthetic progestin, first sold in the mid-2000s in Yaz. Has been linked to an increased risk of blood clots compared to older forms of synthetic progestin

What is the problem with Gianvi?

The problem with Gianvi comes from one controversial ingredient: Drospirenone. It is a novel type of synthetic progestin, which is a female reproductive hormone. Although all birth control pills that contain synthetic progestin slightly increase the risk of developing blood clots, with older types of synthetic progestin (levonorgestrel), the risk was approximately 4-6 per 10,000 women taking the pills. With drospirenone, the risk increases to approximately 10 per 10,000 women taking the pills. Though drospirenone has a slightly higher risk of blood clots, it is equally effective at preventing pregnancy compared to older birth control pills.

When drospirenone-containing birth control pills emerged, tens of millions of women decided to switch to the newer birth control pills. Their decision may have been guided by a massive advertising campaign, which the FDA later deemed “misleading,” because it “failed to communicate any risk information,” and also claimed that the new pills could also improve a woman’s quality of life by treating all acne and PMS. In reality, drospirenone could only treat mild acne and Premenstrual Dysphoric Disorder (PMDD), a severe form of PMS. Even so, Yaz and Yasmin became the most popular birth control pills in the U.S. in 2008 and 2009.

An extra 4-6 cases of blood clots per 10,000 women, translated over tens of millions of women, equals thousands of extra cases of blood clots and potentially life-threatening side effects. One of the most life-threatening side effects of Gianvi and other birth control containing drospirenone is Deep Vein Thrombosis (DVT). This occurs when blood clots form in the extremities, typically in the legs, but also in the pelvis or arms. Blood clots formed by DVT are the leading cause of pulmonary embolisms. If a blood clot forms in a large vein, it can break free, travel through the bloodstream to the lungs (called an “embolism”), and block the artery. This starves the lung tissue of the fresh blood the organ needs to survive.

Gianvi and Pulmonary Embolisms

Gianvi contains a hormone called drospirenone. In some women, it increases potassium levels significantly, which can contribute to the formation of blood clots in the extremities, in a condition called DVT.

Blood clots formed in DVT are the leading cause of pulmonary embolisms or “pulmonary embolus.” If a blood clot eventually manages to break free, it can travel through the bloodstream. If it gets to the lungs, it will eventually be too large to pass through the small blood vessels in the lungs. Pulmonary embolisms are most severe when the blood clot is large, blocking the supply of blood to a large portion of the lungs. However, even small blood clots can cause lung tissue to die. If untreated, around 30% of people with a pulmonary embolism will die, typically within the first few hours of the event.

Signs & Symptoms of a Pulmonary Embolism

A pulmonary embolism can cause lifelong disability or death. If you suspect you have developed a blood clot, or if you have symptoms of a pulmonary embolism, this is an emergency situation and you need to call 911 and seek emergency attention immediately. Do not wait.

Pulmonary embolisms do not always have symptoms. When the embolism occurs suddenly, typical symptoms include:

• Sudden shortness of breath: Rapid breathing. This may occur while active, or at rest. It does not improve while resting.
• Chest Pain: May be sharp, stabbing pain, or a burning, aching, dull pain. Located under the breastbone or on one side of the chest. It may worsen when you breathe deeply, cough, eat, or during exertion. This pain does not improve when you rest.
• Sudden Cough: Wheezing. You may cough up blood or bloody mucous.

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

Gianvi Side Effects

Gianvi side effects include, but are not limited to:

• Depression
• Blood Clots
• Deep Vein Thrombosis (DVT)
• Venous Thromboembolism (VTE)
• Pulmonary Embolism (PE)
• Hyperkalemia
• Stroke
• Abnormal heart rhythm
• Heart Attack
• Myocardial Infarction
• Gallbladder injury
• Pancreatitis
• Death