Have you been injured by the Gianvi birth control pill? Gianvi is a generic version of Bayer’s Yaz birth control pill that was launched by Teva Pharmaceuticals in 2010. Like Yaz, Gianvi is made with a genetic form of progestin called drospirenone. Drospirenone-containing contraceptives like Gianvi have been associated with a higher risk of serious side effects, including stroke, heart attack, pulmonary embolism, deep vein thrombosis and gallbladder disease.
Lawyers at our firm who specialize in defective drug litigation are investigating Gianvi side effects, and are offering free legal consultations to anyone who believes they were hurt by this generic form of Yaz. If you suffered a blood clot, gallbladder problems, stroke or heart attack while taking Gianvi, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. We urge you to contact one of our Gianvi side effects lawyers today to protect your legal rights.
Gianvi Side Effects
Drospirenone, the synthetic progestin found in Gianvi can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, in high risk patients, such as those with renal insufficiency, hepatic dysfunction and adrenal insufficiency. This condition may result in potentially serious heart and health problems. Women who use contraceptives made with drospirenone should undergo periodic blood testing to monitor their potassium levels.
The only other birth control pills which contain ethinyl estradiol and drospirenone are YAZ and Yasmin, as well as Ocella and Zarah, which are generic versions of Yasmin, and Beyaz, which contains the same estrogen-progestin combination as YAZ plus 0.451 mg of levomefolate calcium.
In 2009, a study published in the British Medical Journal reported that birth control pills made with drospirenone were associated with more blood clots than those made with other forms of progestin. The study compared 1,524 patients on the pill and 1,760 who were not. There was a five fold increase in the number of women who suffered a dangerous type of blood clot called venous thrombosis in women taking the pill compared to those who weren’t. Among women who used oral contraceptives that contained drospirenone, there was a 6.3-fold increase in venous thrombosis. The researchers found that low-estrogen oral contraceptives made with a type of progestin called levonorgestrel carried the lowest risk of blood clots.
Increasingly, medical studies are finding a clear link between hormonal contraceptive pills and gallbladder problems. Estrogen raises the cholesterol content of bile, which is produced by the liver and stored in the gallbladder. As cholesterol is the main constituent of gallstones, the excess of cholesterol that the estrogen leaves behind can quickly form into painful gallstones.
It’s also been theorized that the type of hormones contained in a contraceptive may further increase gallbladder risks. For example, the drospirenone found in Gianvi and similar birth control pills acts as a diuretic. The accompanying water loss may make a woman more susceptible to gallbladder problems, as dehydration impedes the function of the gallbladder.
Teva Admits to False Gianvi Statements
The US Food & Drug Administration (FDA) approved the sale of Gianvi in April 2010, but in June, Bayer, which makes Yaz, filed a patent infringement lawsuit against Teva, claiming its marketing of Gianvi broke an agreement between the two companies. According to Bayer, that agreement prohibited the generic drug maker from launching a Yaz generic until at least July 2011.
During the course of that litigation, Teva admitted before a federal court to making false statements about Gianvi. This came after Bayer accused Teva of falsely claiming in Gianvi’s prescribing information that the ethinyl estradiol it contains uses the chemical beta-cyclodextrin as a “clathrate” to stablize it and prolong its shelf life, a patented Bayer technology. In its lawsuit, Bayer said an analysis of Gianvi found it did not use beta-cyclodextrin as a clathrate.
Teva said it would rectify the situation by sending weekly e-mails and faxes to pharmacists throughout the US for three months that contain corrected prescribing information and had already provided the corrected information to the FDA. It also agreed not to ship any more Gianvi products containing any material claiming that the drug uses beta-cyclodextrin as a clathrate.
Legal Help for Victims of Gianvi Side Effects
If you or a loved one suffered a stroke, heart attack, blood clot, gallbladder problem or other injury that you believe may be tied to your use of Gianvi, you may have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-529-4363) to discuss your case with one of our Gianvi injury lawyers today.