Oral contraceptives, otherwise known as birth control pills, are a method in which women are able to lower their risk of becoming pregnant. As a recent addition to the birth control arsenal, Gianvi (generic: drospirenone and ethinyl estradiol) is a fourth generation oral contraceptive that assists in the application of pregnancy prevention. However, the introduction of Gianvi may coincide with severe and adverse health events. Recent studies suggest that fourth generation contraceptives, such as Gianvi, may significantly increase a patients risk of developing life-threatening blood clots.
If you or a loved one has suffered from a blood clot or other adverse cardiac event 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 Blood Clot Lawsuit Overview
Gianvi was developed and distributed as a generic counterpart to the widely popular Yaz birth control pills. While Yaz was introduced in 2006, Teva did not develop Gianvi until 2010 when the original Yaz patent expired. In women who choose oral contraceptives as a form of birth control, Gianvi is approved for the prevention of pregnancy. Gianvi’s pharmacodynamics are also approved for the treatment of premenstrual dysphoric disorder (PMDD) and moderate acne in women at least 14 years of age.
Gianvi is what many consider to be a fourth generation contraception because of the active ingredient found within it. Drospirenone, unique to fourth generation contraception medications including Loryna, Beyaz, Yaz, Yasmin Ocella and now Gianvi, 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.
Unfortunately, the mechanism of action responsible for these results may coincide with catastrophic complications. Women who implement a strict Gianvi regimen may significantly increase their risk of developing severe, life-threatening blood clots. Subsequently, a Gianvi blood clot may result in a variety of complications that vary in severity. Due to the severe nature of these complications, women may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Gianvi blood clot 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
- Stomach cramps
- Weight gain
- Severe allergic reactions
- Breast discharge
- Calf or leg pain
- Irregular heart beat
- Breathing difficulties
Blood clots, otherwise known as thrombi, are the result of a complex mechanism responsible for healing the body. In the presence of a damaged blood vessel, platelets are recruited from the blood stream to the injured area to form an initial plug. 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.
When a blood clot is formed as part of a normal repair process of the body, there is little consequence. However, there are times when blood clots form for unexplained reasons, and this can have potentially significant consequences. The presence of a severe Gianvi blood clot may result in catastrophic complications. Blood clots that prohibit a sufficient amount of blood to be circulated to parts of the body prevent said parts from receiving the appropriate nutrients necessary for survival. Therefore, a blood clot may starve vital organs of oxygen and ultimately lead to severe complications. The following are potential adverse events that may coincide with a Gianvi blood clot:
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Pulmonary embolism
- Cerebrovascular accidents (CVA)
- Heart attack
- Myocardial infraction
- Gallbladder complications
FDA Gianvi Blood Clot 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 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 Blood Clot 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 blood clot lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has suffered from a blood clot 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.