A number of serious side effects have been linked to Gianvi. This medication has been linked to blood clots which can cause a heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism, abnormal heart rhythm, and death. Gianvi is also linked to increased potassium in the bloodstream, which can cause gallbladder injury, pancreatitis, kidney damage, and more.
Overview
Gianvi a daily oral contraceptive (“the pill”) used for the prevention of pregnancy. It is the generic form of Yaz, a medication created by the pharmaceutical company Bayer. Though the patent on Yaz has not yet expired, Bayer teamed up with Teva Pharmaceuticals and Barr Laboratories and began selling Gianvi as a generic alternative. Gianvi was approved by the U.S. Food and Drug Administration (FDA) in 2010.
The Gianvi regimen consists of 24 active tablets that each contain 0.3-mg of of drospirenone, and 0.03-mg of ethinyl estradiol. There are also inactive tablets that help a woman stay in the habit of taking a pill at the same time every day, which is essential for maximum effectiveness. Gianvi is more than 99% effective at preventing pregnancy when taken as directed. It inhibits ovulation (when the woman’s ovaries release an egg), increases the amount of cervical mucous, and changes the lining of the uterus to make it more difficult for a fertilized egg to implant.
Gianvi contains two synthetic female sex hormones: drospirenone and ethinyl estradiol. Ethinyl estradiol is a synthetic version of the female sex hormone estrogen, and its safety is well-established. Drospirenone is a synthetic version of the female sex hormone progestin. There is a growing amount of scientific evidence linking drospirenone to a higher risk of serious side effects, compared to older versions of synthetic progestin, such as levonorgestrel.
Is Gianvi different from Yaz?
Gianvi is a generic form of Yaz. Gianvi has the same side effects as Yaz.
When the patent on brand-name medications expires, pharmaceutical companies often sell generic versions of the same drug at a cheaper price. A generic medication is essentially the same medication as its brand-name alternative. By law, it must contain the same dose, intended use, side effects, route of administration, risks, benefits, safety, and strength as the original medication.
Gianvi and Drospirenone
It is estimated that 10 out of 10,000 women taking a birth control pill that contains drospirenone will develop a blood clot or suffer a serious side effect. This number is slightly higher than the rate for older types of synthetic progestin, which have an estimated 6 per 10,000 risk of side effects. Though four extra cases per 10,000 seems small, millions of women take an oral contraceptive to prevent pregnancy. This translates to tens of thousands of extra cases of side effects. Though drospirenone-containing birth control pills have a higher risk of side effects, they are no more effective at preventing pregnancy.
Studies of drospirenone side effects:
- In 2009, the Canadian Medical Association Journal published a study that found that women who take a birth control pill containing drospirenone are twice as likely to develop deep vein thrombosis (DVT) or pulmonary embolism than women taking a birth control pill without drospirenone.
- In 2011, the British Medical Journal published the results of a study that found a three-fold increased risk of blood clots with drospirenone.
- In November 2011, an Israeli study of 330,000 women found that those taking drospirenone-containing birth control were 43-65% more likely to develop a blood clot.
- In October 2011, the FDA looked at data from nearly 800,000 women, and found that those taking contraceptives with drospirenone were 75% more likely to develop a blood clot compared to other hormonal contraceptives.
Gianvi Side Effects
Drospirenone increases the amount of potassium in a person’s bloodstream. This can cause a condition known as hyperkalemia, which can lead to irregular heartbeat and even death. High levels of potassium can also cause damaged kidneys, damaged pancreas resulting in pancreatitis, and gallbladder disease.
Drospirenone also increases the chance of developing a blood clot. Why are blood clots dangerous? Blood clots often form in the large veins in the arms or the legs. If they break loose (called an “embolism”) they may travel through a person’s bloodstream, and become trapped in a major internal organ. Blood clots in the heart, brain, or lungs can cause heart attacks, stroke, and pulmonary embolism. These severe side effects can lead to death.
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