There is growing evidence linking drospirenone, an ingredient in Gianvi, to a 75% increased chance of developing a blood clot. If a blood clot forms in the body, it can travel to the brain, and become stuck in an artery that supplies blood to the brain. Strokes can cause severe disability or death.
Overview
Gianvi (drospirenone / ethinyl estradiol) is a daily pill taken for the prevention of pregnancy. It consists of 24 “active” tablets that contain the following ingredients:
- 0.3 milligrams drospirenone, a synthetic version of the female sex hormone progestin
- 0.02 milligrams of ethinyl estradiol, a synthetic version of the female sex hormone estrogen
Gianvi is the generic form of Yaz, and many women who were initially taking Yaz switched to Gianvi when it was approved by the FDA in 2010. Though the patent on Yaz does not expire until 2014, Yaz’s manufacturer decided to team up with Teva Pharmaceuticals to produce Gianvi, a cheaper generic alternative. Gianvi and Yaz are essentially the same, containing the same active ingredients, risks, safety, and side effects.
Gianvi and Drospirenone
The problem with Gianvi comes from one controversial ingredient: drospirenone. Several studies have found that a woman who takes a birth control pill containing this ingredient has a 75% higher risk of developing a blood clot compared to older forms of synthetic progestin.
Many older types of birth control contained levonorgestrel, which has an estimated risk of blood clots around 4-6 per 10,000 women taking the medication. With drospirenone, the risk of blood clots is around 10 per 10,000 women.
Though it seems like a relatively small increase, tens of millions of women take an oral birth control pill to prevent pregnancy. An extra 4-6 cases of blood clots per 10,000 women translates to tens of thousands of extra cases of blood clots, with potentially fatal results.
How many deaths have been caused by birth control pills containing drospirenone? Though no one knows the full number, between 2004 through 2008, the FDA received 50 reports of death directly caused by the pills. In addition to these deaths, the FDA has received hundreds of reports of serious side effects linked to the pills.
Gianvi and Strokes
Women who take Gianvi have a higher risk of developing blood clots, which can cause strokes. A stroke is a condition in which a blood clot becomes trapped in an artery supplying blood to the brain. Parts of the brain become starved of oxygen, and quickly die.
One common Gianvi side effect is a condition known as Deep Vein Thrombosis (DVT), which occurs when blood clots form in the large veins in the body, most commonly the legs. Around 50% of DVT cases are symptomless, but they may still cause deadly side effects. Side effects include swelling, pain, warmth over the affected area, and changes in skin color.
If a blood clot forms anywhere in the body, it may become dislodged from its original location and travel through the bloodstream. This is called an “embolism,” and it is incredibly dangerous, because if it becomes stuck in an artery that supplies blood to a major internal organ (such as the brain, heart, or lungs), it can quickly cause debilitation or death.
Strokes caused by blood clots are known as ischemic strokes. Around 80% of strokes are caused by blood clots that travel to the brain and block a major artery that supplies blood to the brain. A stroke caused by an embolism is called an “embolic stroke,” but strokes can also be caused by blood clots that form inside an artery in the brain that is already very narrow, called a “thrombotic stroke.”
In all types of strokes, the risk the clot will block the supply of oxygen-rich blood to brain tissue, causing brain cells to die. If the clot is not dissolved in time, a large portion of the brain tissue may die, causing severe lifelong disability or death.
Symptoms of a Stroke
Symptoms will depend on what part of the brain is deprived of oxygen. Most commonly, symptoms appear suddenly. Sometimes they appear slowly, off and on, over several days.
Warning signs may include:
- Headache
- 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
- Dizziness
- Incontinence
- Personality, mood, or emotional changes
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