As an oral contraceptive, Gianvi (generic: drospirenone and ethinyl estradiol) is intended to prevent pregnancy in women. Other indications suggest that Gianvi may assist in the treatment of premenstrual dysphoric disorder (PMDD) and severe acne. However, recent studies suggest that Gianvi’s mechanism of action may coincide with catastrophic complications. Women who use Gianvi on a regular basis may significantly increase their risk of developing the following potentially fatal conditions: heart attack, stroke, DVT, pulmonary embolism, blood clots, abnormal heart rhythm, gall bladder injury and pancreatitis.
If you or a loved one has been injured by 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 Lawsuit Overview
Gianvi was introduced to the U.S. market by Teva, the worlds largest manufacturer of generic medicines, in 2010. As an oral contraceptive, Gianvi provides a regimen consisting of 24 active film-coated tablets each, containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol. The oral contraceptive is indicated for the prevention of pregnancy in women. However, Gianvi is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) and bouts of moderate acne vulgaris 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 the suppression of gonadotropins may coincide with catastrophic side effects. Recent studies suggest that the use of Gianvi may significantly increase the risk of the following complications: heart attack, stroke, DVT, pulmonary embolism, blood clots, abnormal heart rhythm, gall bladder injury, pancreatitis and death. Due to the severity of these complications, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Gianvi 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
- Chest pain
Researchers have discovered that medications containing drospirenone may put patients at an increased risk of developing severe side effects. Mounting evidence suggests that drospirenone may be responsible for creating concentrated potassium level spikes in a patient’s blood stream. Though potassium is essential in the proper functioning of the body, elevated levels may prove to be dangerous to an individual. Excess potassium may lead to a blockage in the blood stream. Women who use Gianvi may be at a greater risk of developing a stroke, heart attack or venous thromboembolism (blood clot) because of this blockage.
Venous thromboembolism is a condition in which a blood clot (thrombus) forms in one or more of the deep veins in your body, usually in the legs. It is a serious condition because a blood clot that has formed in a vein can break loose and travel to the lungs, which has the potential to cause a heart attack or stroke. Due to the severity of these side effects, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Gianvi lawsuit.
Complications with Gianvi
The following are the results of a case study, published by the British Medical Journal (BMJ), that compared fourth generation contraceptives containing drospirenone with earlier contraceptives that utilized levonorgestrel:
The risk of venous thromboembolism among users of oral contraceptives containing drospirenone seems to be around twice that of users of oral contraceptives containing levonorgestrel.
186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100 000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100 000 woman years among users of oral contraceptives containing levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing levonorgestrel was 2.8 (2.1 to 3.8).
Several studies have investigated the relative risks of thromboembolism in women using drospirenone-containing contraceptives compared to those in women using COCs containing other progestins. Accordingly, two prospective cohort studies have evaluated the risk of venous and arterial thromboembolism and death, as they relate to corresponding contrceptives. The first (EURAS) showed the risk of thromboembolism (particularly venous thromboembolism) and death in drospirenone users to be comparable to that of other oral contraceptive preparations, including those containing levonorgestrel (a so-called second generation COC). The second prospective cohort study (Ingenix) also showed a comparable risk of thromboembolism in drospirenone users compared to users of other COCs, including those containing levonorgestrel. In the second study, COC comparator groups were selected based on their having similar characteristics to those being prescribed drospirenone-containing contraceptives. Complications such as these have led to thousands of women filing their own Gianvi lawsuit against Teva.
Gianvi Label Change to Include Risk of Blood Clots
The FDA has recently completed a review of observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on the data acknowledged in the review, officials at the FDA have concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. To put the risk of developing a blood clot from a birth control pill into perspective: The risk of developing a blood clots is higher when using any birth control pills than not using them. As a result, the FDA has requested a label change.
According to a Drug Safety Communication, the revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins.
Gianvi Lawsuits Still Possible After 2011 Supreme Court Preemption Ruling
Although, the first patent for Yaz doesn’t expire until June 2014, there are already generic versions of the birth control pill on pharmaceutical store shelves. As one of the generic counterparts to Yaz, Gianvi is an oral contraceptive that is jointly marketed by two of the industries leading generic drug manufacturers, Teva Pharmaceuticals and Barr Laboratories.
Unfortunately, a growing influx of women who have received Gianvi treatment claim to have experienced severe, life-threatening complications. Included in these complications are the development of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke (CVA), and heart attack. However, when seeking litigation, many of these women are confronted by legal professionals who insist that they cannot file any personal injury (or wrongful death) lawsuit against these generic drug companies because of last years preemption ruling in the Supreme Court.
In the case of Pliva, Inc., et al. v. Mensing, the Supreme Court of the United States ruled that federal drug regulations applicable to generic drug manufacturers directly conflict with – and thus pre-empt – state law claims. Subsequently, the U.S. Supreme Court ruled in favor of the generic drug companies while simultaneously ruling against the injured patients. As a result, any “failure to warn” lawsuit involving a generic drug would be dismissed based on this Mensing case ruling.
However, women who experienced Gianvi complications may still have a legal claim, due to the fact that Bayer has been manufacturing the Gianvi birth control pills. As a result, Bayer may share some of the legal liability for Gianvi lawsuits.
Do I Have a Gianvi 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 lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by 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.