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Gianvi Side Effects Could Include Blood Clots, Stroke, Heart Attacks, Gall Bladder Problems

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While Yaz lawsuits against Bayer has made many people aware of the dangerous Yaz side effects, another contraceptive with the same risks is flying under the radar. That drug, Teva Pharmaceuticals’ Gianvi, is nothing more than a generic form of Yaz.

Both Gianvi and Yaz contain a synthetic form of progestin called drospirenone, which may be associated with an increased risk of stroke, heart attack, pulmonary embolism, deep vein thrombosis and gallbladder disease. Adverse Events reported to the FDA involving drospirenone birth control pills include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.

Contraceptives like Gianvi should not be taken by high risk patients, such as those with renal insufficiency, hepatic dysfunction and adrenal insufficiency. Women who use contraceptives made with drospirenone should undergo periodic blood testing to monitor their potassium levels, as hyperkalemia can lead to serious heart and health problems.

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.

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. 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.

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