Gianvi (drospirenone/ethinyl estradiol) is the generic form of Yaz, a birth control pill. Gianvi contains drospirenone, which has recently been linked to severe, life-threatening side effects, including blood clots, strokes, pulmonary embolisms, and death. Bayer now faces more than 11,000 lawsuits brought by women who have been injured by severe side effects of birth control pills containing drospirenone.
Gianvi is a once-daily oral birth control pill. In 2010, the U.S. Food and Drug Administration (FDA) approved Gianvi to prevent pregnancy. It can also reduce mild acne and treat symptoms of premenstrual dysphoric disorder (PMDD). Gianvi is not approved to treat PMS or severe acne.
Gianvi is the generic form of Yaz. Both medications contain the same amount of active ingredients, the same risks, benefits, and side effects. The only major difference is that Yaz is sold by Bayer, and Gianvi is sold by a generic drug company called Teva Pharmaceuticals. Gianvi and Yaz are equally effective at preventing pregnancy, but Gianvi usually costs less than Yaz, which is why many women switched from Yaz to Gianvi when it was approved in 2010.
The Gianvi regimen consists of 24 active tablets, which each contain 3 mg of drospirenone (synthetic progestin) and 0.020 mg of ethinyl estradiol (synthetic estrogen). Four additional tablets are inactive, but help a woman stay in the habit of taking the pill at the same time every day.
When taken as directed, Gianvi is more than 99% effective at preventing pregnancy. It uses several mechanisms to decrease the chance that a woman will conceive. Gianvi inhibits the ovaries from releasing an egg (ovulation), and also changes the cervical mucus, which makes it difficult for sperm to enter the uterus. Gianvi also changes the endometrium, which makes it difficult for a fertilized egg to implant and grow.
Gianvi belongs to the “fourth generation” of oral contraceptives that contain drospirenone, a synthetic form of the female sex hormone progestin. Other contraceptives in this category include Yaz, Yasmin, Ocella, Beyaz, Zarah, Safyral, and Syeda.
What is the problem with Drospirenone?
Gianvi, Yaz, and other “fourth generation” contraceptives contain drospirenone. Drospirenone is under intense scrutiny after several studies found significantly higher risk of side effects than older types of birth control.
All birth control pills increase a woman’s risk of blood clots. Birth control pills that have been on the market since the 1980s have been studied thoroughly, and the FDA has concluded that the risk of side effects is small.
However, five new studies have linked drospirenone to a significantly increased risk of blood clots, strokes, pulmonary embolisms, and death. These non-FDA studies have found similar results:
- 2009: Two studies published in the Canadian Medical Association Journal found that women may be twice as likely to develop a blood clot compared to women using other forms of birth control.
- 2011: Two studies published in the British Medical Journal, found women who took birth control with drospirenone were up to three times more likely to develop a blood clot.
- November 2011: A massive Israeli study followed 329,995 women in Israel found the risk of blood clots may be more than 40% higher for drospirenone-containing contraceptives.
FDA Safety Warning for Drospirenone
October 2011 — The FDA announced results of a preliminary study. After studying nearly 800,000 women using contraceptives with drospirenone, the FDA found women have at least a 75% increased chance of developing a blood clot compared with non-drospirenone contraceptives. The risk of developing blood clots is greatest for women in their first year of taking Gianvi or Yaz.