As the generic version of Yaz, Gianvi (drospirenone and ethinyl estradiol) is intended to assist in the prevention of pregnancy in women who choose the method of oral birth control. When used as directed, Gianvi has proven to be 99% effective. However, the introduction of fourth generation contraceptives that contain drospirenone may coincide with complications that do not exhibit a favorable risk/benefit profile. Women who use Gianvi for a prolonged period of time may develop deep vein thrombosis (DVT), a serious blood clot that can lead to subsequent adverse cardiac events.
If you or a loved one has suffered from deep vein thrombosis or other adverse cardiac events after taking Gianvi, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Gianvi Deep Vein Thrombosis Lawsuit Overview
Teva, the global leader in the manufacturing and development of generic medications, introduced Gianvi to the U.S. market approximately two years ago in 2010. Accordingly, Gianvi was approved by the U.S. Food and Drug Administration (FDA) to assist in the prevention of pregnancy in those women who choose to use oral contraceptives. In addition to birth control, Gianvi has also been approved to treat premenstrual dysphoric disorder (PMDD) and moderate acne in women at least 14 years of age.
Due to Gianvi’s unique dual action formula, it is considered a fourth generation contraceptive. Gianvi’s active ingredient, drospirenone, is found in similar fourth generation contraceptives such as Loryna, Beyaz, Yaz, Yasmin Ocella. Drospirenone is a progestin with the ability to prevent the ovulation process in women by altering conditions in the cervical and uterine lining. Combination oral contraceptives (COCs) such as these act by suppressing gonadotropins. Although the primary mechanism of this action is the inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation). As a result, these altered conditions make it more difficult for any sperm to reach the uterus. Therefore serving as an affective form of birth control.
While 99% effective in the prevention of pregnancy, Gianvi treatment is not without concern. Prolonged exposure to drospirenone may coincide with catastrophic complications. Women who use Gianvi for a prolonged period of time may develop deep vein thrombosis, a serious blood clot that can lead to subsequent adverse cardiac events. Due to the severe nature of these complications, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Gianvi deep vein thrombosis lawsuit.
Gianvi Side Effects
The following is a comprehensive list of the side effects associated with the use Gianvi:
- Breast tenderness
- Bleeding between menstrual periods
- Nausea
- Stomach cramps
- Vomiting
- Weight gain
- Severe allergic reactions
- Breast discharge
- Calf or leg pain
- Irregular heart beat
- Breathing difficulties
Deep Vein Thrombosis
Deep vein thrombosis is characterized by the formation of a blood clot in a vein deep within the tissue. Also known as thrombi, DVT is the result of the body trying to heal itself from any injuries the blood vessel has sustained. In the presence of a damaged blood vessel, platelets are recruited from the blood stream to the injured area to form a blockage to prevent blood loss. These activated platelets release chemicals that start the clotting cascade, using a series of clotting factors produced by the body. Ultimately, fibrin is formed, the protein that crosslinks with itself to form a mesh that makes up the final blood clot. While DVT can occur in any deep vein, it is most commonly seen in the femoral popliteal veins of the legs.
While deep vein thrombi are considered a safety mechanism, their presence may result in catastrophic complications. If the clotting process is too extensive, and not enough blood is permitted to pass, the circulatory system is unable to maintain an efficient flow of blood. The clot therefore serves as an obstacle in the blood stream that prevents the transportation of nutrients and oxygen to the rest of the body. As a result, vital organs may starve and eventually suffer from severe complications. The following complications may result from deep vein thrombosis:
- Venous thromboembolism (VTE)
- Pulmonary embolism
- Hyperkalemia
- Cerebrovascular accidents (CVA)
- Heart attack
- Myocardial infraction
- Gallbladder complications
- Death
FDA Safety Communication
According to an FDA Safety Communication, the agency is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of serious blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills.
Do I Have a Gianvi Deep Vein Thrombosis Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Gianvi deep vein thrombosis lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has suffered from a deep vein thrombosis or other adverse cardiac event after taking Gianvi, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.