The contraceptive Gianvi, the generic form of Yaz, has been linked to the following severe side effects: blood clots, heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism, abnormal heart rhythm, and death. Gianvi also significantly increases the amount of potassium in a woman’s bloodstream, which can cause kidney damage, pancreatitis, gallbladder injury, and more.
UPDATE
April 2012 — The FDA has recently announced that it will be updating the drug safety information for all birth control pills containing drospirenone. In a statement, they said: “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA will be updating the drug safety information to warn about the increased risk of blood clots associated with drospirenone.
Overview
Gianvi is a prescription contraceptive medication used to prevent pregnancy. It is a generic form of Yaz, which is one of the most popular oral contraceptives in the world. When the patent on Yaz expired, an Israeli pharmaceutical company called Teva Pharmaceuticals began producing Gianvi. The U.S. Food and Drug Administration (FDA) approved Gianvi for contraception in 2010.
Gianvi comes in an oral tablet form. It is a daily regiment, consisting of 24 active tablets. Each active tablet contains 0.3-mg of drospirenone (synthetic form of the female sex hormone progestin) and 0.03-mg of ethinyl estradiol (synthetic form of the female sex hormone estrogen).
When taken every day at the same time, Gianvi is more than 99% effective at preventing pregnancy. It prevents pregnancy by inhibiting a woman’s ovaries from releasing an egg (ovulation), increasing cervical mucous to make it more difficult for sperm to enter the uterus, and changing the endothelium (lining of the uterus) so a fertilized egg is less likely to implant.
Is Gianvi different from Yaz?
If you took Gianvi to prevent pregnancy, you may have originally been prescribed Yaz. Though some women swear that they notice changes when switching from a brand-name medication to a generic, Gianvi is essentially the same medication as Yaz. Both medications contain the same amount of active ingredients. They have the same benefits, side effects, dosage, route of administration, intended use, safety and strength.
The medication Yaz has come under intense scrutiny after the FDA found that the advertising was misleading to consumers. You probably remember popular advertisements featuring women popping balloons labeled “acne” and “PMS” while singing “We’re not going to take it.” The FDA warned that the ads were misleading, because they implied that Yaz was safer than other types of oral contraceptives. In reality, Yaz was no more effective at preventing pregnancy, had more serious side effects than older contraceptives. Furthermore, Yaz was only approved to treat mild acne and symptoms of Premenstrual Dysphoric Disorder (PMDD), a very serious mood disorder that is not the same as PMS. The FDA sent several warning letters to the manufacturers, prompting the company to run a $20 million corrective advertising campaign.
Gianvi and Drospirenone
The controversy surrounding Gianvi, Yaz, and other “fourth generation” birth control pills comes from side effects of drospirenone. Though all forms of synthetic progestin increase the risk of blood clots, with older forms, the risk was approximately 6 per 10,000 women. With drospirenone, however, the risk increases to 10 per 10,000 women. At first, it seems like a minor increase. However, tens of millions of women use a birth control pill that contains drospirenone. This means that tens of thousands of women have suffered a severe side effect. Although Gianvi and other contraceptives with drospirenone have a higher risk of side effects than other hormonal contraceptives, they are no more or less effective at preventing pregnancy.
Several studies have found links between the use of Gianvi and blood clots:
- This study published in the Canadian Medical Association Journal in 2009 found that the risk of deep vein thrombosis (DVT) and pulmonary embolism were twice as likely to occur in women taking a contraceptive with drospirenone.
- This study published in the British Medical Journal in 2011 found that the risk of blood clots was three times higher for women who were taking a contraceptive with drospirenone.
- This study of almost 330,000 women in Israel found that blood clots were 43-65% more likely in women taking a contraceptive with drospirenone.
- This study of 800,000 women prompted an FDA Drug Safety Warning, after finding that the risk of blood clots was 75% higher for women taking a contraceptive with drospirenone.
Gianvi Side Effects
Gianvi contains drospirenone, which can significantly increase the amount of potassium in a woman’s bloodstream. In addition to increasing the risk of blood clots, high potassium levels can cause hyperkalemia, a condition that causes irregular heartbeat and death. Chronically high potassium levels can also cause pancreatitis (damage to the pancreas), kidney damage, and gallbladder disease.
Blood clots can also be incredibly dangerous, and they don’t always have symptoms. Gianvi is linked to a condition known as Deep Vein Thrombosis (DVT), where blood clots form in the large veins in the legs. These blood clots may break loose, becoming an “embolism,” which may travel through the body and become trapped in a major internal organ. If this happens, a blood clot can block the supply of blood to the organ and cause permanent disability or death. Blood clots can cause heart attacks, stroke, pulmonary embolism, and death.
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