Gianvi (the generic version of Yaz) contains one controversial ingredient: drospirenone. Researchers have found that drospirenone may increase the risk of blood clots by 75%. A blood clot that travels to the brain may become trapped in an artery supplying oxygen to brain cells, called a stroke.
Gianvi, the generic form of Yaz, is a daily pill used for the prevention of pregnancy. It is manufactured by Teva Pharmaceuticals and was approved by the U.S. Food and Drug Administration (FDA) in 2010.
The Gianvi regimen consists of 24 active tablets, each containing the following ingredients:
- 0.3 milligrams drospirenone, which is a new, “fourth generation,” synthetic form of the female sex hormone progestin
- 0.02 milligrams of ethinyl estradiol, which is a synthetic version of the female sex hormone estrogen, and has a long history of safe use in birth control pills
Many women who took Gianvi when it became available in 2010 were initially prescribed Yaz, which was the most popular birth control pill in the United States in 2008 and 2009. Millions of women switched from older types of birth control pills to Yaz, and then switched to Gianvi because it was cheaper and equally effective. Gianvi and Yaz are essentially the same pill, with the same active ingredients, safety, risks, and side effects.
Gianvi and Drospirenone
Gianvi contains drospirenone, a synthetic substance that mimics progestin, a female reproductive hormone. Drospirenone is a “fourth generation” synthetic progestin. All types of synthetic progestin increase a woman’s risk of developing a blood clot. With older generations of synthetic progestin (such as levonorgestrel) it was estimated that between 4-6 women per 10,000 would develop a blood clot. With drospirenone, however, the risk increases to around 10 per 10,000. This is a 75% higher risk of developing a blood clot compared to older forms of synthetic progestin. Numerically, it seems like a small increase. However, because tens of millions of women switched to a birth control pill containing drospirenone, an extra 4-6 cases of blood clots per 10,000 women translates to tens of thousands of extra cases of blood clots.
Some of these women have died. The FDA received 50 reports of deaths caused by drospirenone between 2004 and 2008. It is likely that there have actually been more unreported deaths. Furthermore, hundreds of women have reported suffering a serious adverse event (including strokes) as a direct result of taking a birth control pill containing drospirenone.
Gianvi and Strokes
One serious, life-threatening side effect of Gianvi is a stroke.
A stroke occurs when a blood clot enters the brain, becomes trapped in an artery, and blocks the supply of oxygen-rich blood to a part of the brain. Within minutes, it can cause brain tissue to become starved of oxygen, causing brain cells to die. Brain damage is irreversible. It can cause permanent disability or death.
Gianvi increases a woman’s risk of developing a blood clot. Strokes caused by blood clots are known as ischemic strokes, and they make up 80% of strokes in the brain. There are two types of ischemic strokes: 1) embolic strokes, and 2) thrombotic strokes.
An embolic stroke is caused by a blood clot that travels through the bloodstream (called an “embolism”) and becomes stuck int the brain. Gianvi increases the risk of a condition called Deep Vein Thrombosis (DVT), in which blood clots form in the large arteries in the legs. DVT is a symptomless in 50% of cases, but when it does have symptoms, a person may have swelling, pain, warmth in the legs, or changes in skin color that indicate they have developed a blood clot that is affecting circulation. If a DVT blood clot breaks loose, it can travel to the brain and cause an embolic stroke.
A thrombotic stroke occurs when blood clots form in arteries in the brain that are narrow.
Symptoms of a Stroke
Any time a stroke is suspected, this is a 911 emergency. Do not wait.
Stoke symptoms can come on suddenly or appear slowly over several days, off and on. The exact symptoms depend on the part of the brain that is being starved of oxygen by the blood clot.
Warning signs may include:
- Muscle weakness, tingling, or numbness in the face, arm, leg, usually only on one side
- Change in alertness (drowsiness, loss of consciousness, coma)
- Changes in sensation (hearing, taste, touch)
- Slurred speech
- Blurry vision, loss of vision
- Clumsy motor coordination; difficulty walking, writing, balancing, reading, swallowing
- Confusion, loss of memory
- Personality, mood, or emotional changes