Gianvi (the generic form of Yaz) is a popular oral contraceptive that contains drospirenone, a synthetic substance that has been linked to an increased risk of blood clots, which can cause heart attacks, stroke, deep vein thrombosis (DVT), pulmonary embolism, and death. Gianvi may also increase the amount of potassium in a woman’s bloodstream to dangerous levels, causing irregular heartbeat, gallbladder injury, pancreatitis, and kidney injury.form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Gianvi Overview
Gianvi is one of the newest oral contraceptives in the “fourth generation” of oral birth control pills that contain drospirenone. Since the U.S. Food and Drug Administration (FDA) approved Gianvi in 2010, it has become a popular generic alternative to Yaz. Most times, generic medications do not become available until the patent on the original medication expires. Though the patent on Yaz expires in 2014, Bayer teamed up with Teva Pharmaceuticals to create Gianvi, a generic version of Yaz.
Gianvi has all the same active ingredients, benefits, risks, and side effects as Yaz. If you took Gianvi and suffered a serious side effect, you may have been prescribed Yaz initially. During the height of Yaz’s popularity, advertisements failed to warn women of the serious side effects, including heart attacks, causing many women to choose Gianvi or Yaz over alternative medications. Though Gianvi has a slightly higher risk of blood clots, it is no more or less effective at preventing pregnancy than older birth control pills.
Gianvi and Drospirenone
Gianvi contains drospirenone which is synthetic progestin. Most oral birth control pills, including Gianvi, contain a combination of synthetic estrogen and synthetic progestin. The safety of synthetic estrogen is well-established. However, all types of synthetic progestin slightly increase a woman’s risk of developing a blood clot. With older forms of synthetic progestin, such as levonorgestrel, the risk was estimated to be between 4-6 women per 10,000 taking a pill containing the substance. However, with drospirenone, the risk is estimated to be around 10 per 10,000 women. Though, numerically, this seems insignificant, tens of millions of women take an oral birth control pill. A slightly increased risk translates to tens of thousands of excess cases of blood clots.
In October 2011, the FDA analyzed data on more than 800,000 women taking a birth control pill containing drospirenone. They found that the women taking drospirenone were 75% more likely to develop a blood clot.
Gianvi and Heart Attacks
The problem with blood clots is that they can cause heart attack, stroke, pulmonary embolism, and death. Blood clots and heart attacks are the most serious, dangerous side effects of Gianvi.
A heart attack, also known as a “myocardial infarction” or “coronary thrombosis,” is a serious, life-threatening condition that occurs when a blood clot blocks a coronary artery, the artery that supplies the heart muscle with oxygen-rich blood. Deprived of oxygen, the heart tissue will begin to die within 20-40 minutes. Once heart tissue dies, it is impossible to reverse. Around one millions people in the U.S. suffer a heart attack every year. Of these, 400,000 will die from the heart attack.
Symptoms of a Heart Attack
The most common initial symptom of a heart attack is chest pain (angina), which is a sign that the coronary arteries may be partially blocked. If you experience chest pain while taking Gianvi, you may be facing an emergency situation and you to reach an emergency physician immediately.
Other symptoms of a heart attack include:
- Sharp pain behind the beast bone, on the upper-left side of the chest. Pain may spread to the left arm.
- Pain may extend to the hands, jaw, stomach, right arm, or other parts of the body.
- It may be difficult to breathe
- Fainting, light-headedness, severe dizziness
Gianvi and Yaz
Gianvi is the generic form of Yaz. If you take Gianvi, you may have been prescribed Yaz initially. You may have also seen the advertisements for Yaz and other “fourth generation” birth control pills and been inspired to switch medications.
Yaz is a contraceptive medication created by the pharmaceutical company Bayer. It was the most popular birth control pill in the United States in 2008 and 2009, used by tens of millions of women to prevent pregnancy. If you watched television during the height of Yaz’s popularity, you probably saw a variety of advertisements for the medication, such as women popping balloons labeled “acne” or “bloating” while singing “We’re not going to take it anymore.” Yaz owes much of its popularity to a multi-million dollar advertising campaign that portrayed it as a birth control pill that could also enhance a woman’s quality of life.
Unfortunately, the FDA issued warning letters to the marketing team behind this advertising campaign, because they were “misleading,” “overstate the efficacy … and minimize serious risks,” and “fail to communicate any risk information,” which could cause a women to choose this medication over alternatives because she is not aware of the risks. The FDA sent the first warning letter in 2008, and a second one in 2009. These warning letter prompted Bayer to spend $20 on a corrective advertising campaign, but by then, millions of women had switched to Yaz, or other birth control pills containing drospirenone.
Yaz is only approved to treat mild acne, not moderate or severe acne. Yaz is also not approved to treat PMS. It is approved to treat Premenstrual Dysphoric Disorder (PMDD), a severe mood disorder that some women experience while menstruating.
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