Gianvi is an oral birth control pill that contains drospirenone, a controversial ingredient that has been linked to a 75% increased risk of developing blood clots, compared to older birth control pills. If a blood clot breaks loose in the bloodstream, it can cause a heart attack, stroke, pulmonary embolism, lifelong disability, or death.
Gianvi is a once-daily, oral birth control pill. It belongs to the “fourth generation” of oral birth control, which all contain drospirenone, a new form of synthetic progestin. Gianvi was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of pregnancy. It is also approved to treat mild acne and symptoms of Premenstrual Dysphoric Disorder (PMDD), a severe form of Premenstrual Syndrome (PMS) that afflicts 3-8% of women.
The active Gianvi pills contain the following medications:
- Drospirenone (0.3-mg): Synthetic version of progestin, a female reproductive hormone. It was initially approved in 2004 in Yaz, and since then, several studies have linked it to an increased risk of blood clots.
- Ethinyl estradiol (0.02-mg): Synthetic version of estrogen, a female reproductive hormone. It has been used in medicine since the 1940s, and has a long history of safe use.
Gianvi is the generic form of Yaz. Gianvi and Yaz contain the same amount of active ingredients, including drospirenone. They also have the same dosage, intended purpose, effectiveness, safety, and side effects. The major differences are price and manufacturer. Yaz is created by Bayer. Although the patent on Yaz does not expire until 2014, the manufacturers, Bayer partnered with Teva Pharmaceuticals, an Israeli pharmaceutical company, to create Gianvi as a cheaper, generic alternative to Yaz.
Drospirenone and Blood Clots
Compared to older types of oral contraceptives, “fourth generation” oral contraceptives that contain drospirenone increase a woman’s risk of developing a blood clot by 75%. Though the risk is still very small, tens of millions of women chose to switch from an older birth control pill to a “fourth generation” pill after Bayer ran a massive advertising campaign promoting Yaz and Yasmin. Though the “fourth generation” pills were no more or less effective at preventing pregnancy, they had a slightly higher risk of blood clots.
How much higher is the risk of blood clots? All types of synthetic progestin carry a risk of blood clots. Before drospirenone, the most common form of synthetic progestin was levonorgestrel. Around 4-6 women per 10,000 taking levonorgestrel developed blood clots. With drospirenone, the estimated risk is slightly higher — around 10 women per 10,000. This means that there are approximately 4-6 extra cases of blood clots per 10,000 women taking drospirenone instead of levonorgestrel.
Though this slightly increased risk doesn’t seem significant, tens of millions of women take an oral birth control pill to prevent pregnancy. A significant number of these women switched from an older birth control to a “fourth generation” pill. Yaz was the most popular birth control pill in the United States in 2008 and 2009. A slightly increased risk translates to tens of thousands of extra cases of blood clots.
Between 2004 and 2008, the FDA received reports of 50 deaths directly linked to the birth control pills. These are the most serious side effects of taking Gianvi and other “fourth generation” birth control pills. The FDA has also received hundreds of reports of serious side effects. These side effects can cause permanent disability.
Gianvi and Blood Clots
It is thought that Gianvi increases the risk of blood clots by increasing the amount of potassium in a woman’s bloodstream. Excess potassium can cause the blood to thicken excessively, particularly in the extremities, which is why people who take Gianvi are more likely to develop a blood clot condition known as Deep Vein Thrombosis (DVT), where blood clots form in the leg. Less commonly, Gianvi has also been linked to arterial thrombosis, where blood clots form in the arms. When a person has DVT, the clot restricts the flow of blood back into the heart. Around half of DVT cases show symptoms of swelling and pain in the affected area — the other half are symptomless.
What is a blood clot? A blood clot is a sticky mass of red blood cells. Blood clots are a necessary part of healing. When a person is injured, enzymes dissolved in the bloodstream trigger the blood to form clots that block an artery and stop bleeding. Blood clots may also form when there is no injury, however. Most of the time, blood clots dissolve on their own. If they do not dissolve, however, they can break loose from their point of origin, travel through the bloodstream (called an “embolism”), and block an artery that supplies oxygen-rich blood to an organ.
Symptoms of a Blood Clot
A blood clot can form anywhere in the body. Women who are taking Gianvi should be aware of the symptoms of a blood clot, so they can recognize early warning signs:
- Swollen or tenderness at the site of the clot
- Pain in one part of the body
- Temperature differences in the extremity (the part of the body with the clot will be warmer)
- Sharp, shooting pain when the affected part of the body is moved
- More visible surface veins
- Redness at the site of the clot