A hormone contained in the popular birth control pill Gianvi has been linked to side effects including blood clots and venous thromboembolism (VTE). Drospirenone was recently the subject of two independent studies that confirmed the hormone placed users at a significantly increased risk of these conditions than women who took other forms of birth control. Gianvi users are advised to carefully weigh the risks vs. rewards of continuing taking the medication.
Gianvi Update 6/26/12: A new study has found that a widely prescribed class of contraceptive products containing a synthetic hormone known as drospirenone may increase the risk for irritable bowel syndrome (IBS), a chronic condition that involves symptoms such as severe abdominal pain, discomfort, bloating, and altered bowel habits. The researchers found that women were almost twice as likely to be diagnosed with IBS after initiating a regimen of drospirenone-based birth control pills than women who took products containing levonorgestrel, a ‘third generation’ progestin found in many older types of contraceptives. Click here to learn more.
Gianvi Blood Clot Lawsuit Update 4/13/12: Pharmaceutical giant Bayer will pay at least $110 million to settle approximately 500 lawsuits over claims that its controversial line of Yasmin birth control products cause blood clots. Officials of Germany’s largest drugmaker reportedly agreed to pay an average of about $220,000 a case to resolve the complaints, people familiar with the agreements said. Click here to learn more.
Gianvi Blood Clot Update 4/10/12: Birth control products containing the synthetic hormone drospirenone have been linked to an increased risk for blood clots, according to a warning issued today by the U.S. Food & Drug Administration (FDA). In response to these findings, the FDA has required that all drospirenone-containing contraceptives carry warnings which state that several studies have found as much as a three-fold increased risk of blood clots associated with drospirenone when compared to levonorgestrel, a different hormone found in many older forms of birth control. Click here to learn more.
Gianvi Blood Clot Update 12/9/11: An independent advisory panel to the FDA has recommended that all birth control products containing the hormone drospirenone should have their labels updated to include warnings about blood clots. The panel’s recommendation was based on new data suggesting that the popular contraceptives may put women at a higher risk for dangerous blood clots than older forms of birth control. Click here to learn more.
Free Gianvi Case Evaluation: If you or a loved one had injuries including but not limited to heart attack, stroke, DVT, pulmonary embolism, blood clots, abnormal heart rhythm, gall bladder injury, pancreatitis or death sustained as a result of Yaz, Yasmin, or Ocella birth control pills, , you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What is Gianvi?
Gianvi (drospirenone and ethyl estradiol) is a generic form of the oral contraceptive drug Yaz. Marketed and manufactured by Teva Pharmaceuticals, Gianvi was approved by the U.S. Food & Drug Administration (FDA) in 2010 as an oral birth control regimen. Combination oral contraceptives (COCs) like Gianvi work by inhibiting ovulation, changing the cervical mucus to make conditions difficult for the sperm to enter the uterus, thus reducing the likelihood of implantation. Despite its short-term success as an oral contraceptive, Gianvi contains drospirenone, which has increasingly been linked to a host of serious cardiovascular events in certain users.
Side Effects of Gianvi
The drospirenone contained in Gianvi may lead to the following side effects:
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Pulmonary Embolism (PE)
- Cerebrovascular Accidents (CVA)
- Heart Attack
- Gallbladder Disease
- Myocardial Infarction
It has also been theorized that drospirenone may increase gallbladder risks, as the hormone has been known to act as a diuretic. The accompanying water loss may make a user more susceptible to gallbladder problems, as dehydration inhibits the function of the gallbladder. These conditions may result in potentially life-threatening health problems. Women who are currently taking Gianvi should undergo periodic blood testing to monitor their potassium levels.
Gianvi & Venous Thromboembolism (VTE)
Two recent studies that evaluated the risk of VTE in women who use drospirenone-containing pills found that there is a two to three times greater risk of developing the condition compared to users who took birth control products containing levonorgestrel, a different hormone used in many older brands of birth control pills. The FDA is currently evaluating the results of the studies in an attempt to determine the hormone’s role in cardiovascular events like venous thromboembolism in birth control users. Along with Gianvi, drugs that contain drospirenone include:
Gianvi Lawsuits Still Possible After 2011 Supreme Court Preemption Ruling
Gianvi is jointly marketed by Teva Pharmaceuticals and Barr Laboratories, two firms that are commonly known as generic drug companies. Unfortunately, most women who took Gianvi and suffered serious side effects have been wrongly informed by their lawyers that they cannot file any personal injury or wrongful death lawsuit against these companies because of a legal defense known as ‘federal preemption.’
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. This means that any “failure to warn” lawsuit involving a generic drug would be dismissed based on the Mensing case ruling.
However, due to the fact that Bayer has been manufacturing Gianvi for Barr and Teva, there may still be a legal claim available for women suffering from Gianvi side effects. It seems Bayer may share some of the legal responsibility for drug injury lawsuits involving Gianvi. This is a similar situation to the arrangement Bayer has with Teva and Barr with regard for Ocella, which Bayer manufactures as well.
Do I have a Gianvi Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Gianvi lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot and VTE cases in all 50 states.