Blood clots are a severe, life-threatening side effect of Gianvi. A blood clot can cause a heart attack, stroke, pulmonary embolism, and death. There is growing concern that drospirenone, an ingredient in Gianvi, increases a woman’s risk of developing a blood clot by 75% compared to other birth control pills.
Gianvi (the generic form of Yaz) is a once-daily oral contraceptive. When used properly, it is more than 99% effective at preventing pregnancy. The regimen consists of seven inactive pills, and 24 active pills that contain two drugs:
- 0.3-mg drospirenone: This ingredient is responsible for most of the controversy regarding Gianvi. Drospirenone is a “fourth generation” version of synthetic progestin, a female reproductive hormone.
- 0.02-mg ethinyl estradiol: This ingredient is synthetic estrogen, a female reproductive hormone. It has a long history of safe use.
Gianvi is manufactured by Teva Pharmaceuticals. It is essentially the same medication as Yaz, a contraceptive created by Bayer. Both medications contain the same active ingredients (including drospirenone), dosage, effectiveness, safety, and side effects. However, because Gianvi is a generic medicine, it costs less than Yaz. When the U.S. Food and Drug Administration (FDA) approved Gianvi in 2010, many women switched to Gianvi.
What is the problem with Drospirenone?
Drospirenone has been linked to a 75% higher risk of developing a blood clot compared to older forms of oral birth control. What does this mean in real numbers? For women taking a birth control pill containing an older form of synthetic progestin (such as levonorgestrel) the risk of developing a blood clot is roughly 4-6 women per 10,000. For women taking a birth control pill containing drospirenone, however, this number is around 10 per 10,000. The actual risk is very small. However, tens of millions of women switched from older forms of birth control to the newer forms, mostly due to a massive advertising campaign that made Yaz the most popular birth control pill in the U.S. in 2008 and 2009. Though the newer pills are no more or less effective at preventing pregnancy, they do have a slightly higher risk of causing blood clots. An extra 4-6 cases of blood clots per 10,000 may not seem like very many, but tens of millions of women use these medications. This means that there may be thousands of extra cases of blood clots, with potentially fatal results.
Between 2004 through 2008, the FDA received at least 50 reports of deaths caused by birth control pills containing drospirenone. Furthermore, the agency received hundreds of reports of potentially life-threatening adverse events linked to the medications. If you suffered a severe side effect after taking Gianvi, you are not alone.
Gianvi and Blood Clots
Gianvi contains drospirenone, which is known to increase potassium levels in the bloodstream. For some people, it may increase potassium levels too much (a condition called “hyperkalemia”). The extra potassium in a woman’s bloodstream may cause blood to thicken excessively, leading to a condition known as Deep Vein Thrombosis (DVT) (when blood clots form in the large vessels in the legs) or arterial thrombosis (when blood clots form in the large vessels in the arms).
Blood clots are semi-solid masses of sticky red blood cells. The body normally produces blood clots to seal off arteries that are bleeding. The process of clotting begins whenever flowing blood is exposed to certain substances that are dissolved in the bloodstream. Sometimes, however, clots form inside vessels without an injury and they do not dissolve naturally. This can cause life-threatening side effects.
Deep Vein Thrombosis (DVT) is one of the most common complications of a blood clot caused by Gianvi. DVT occurs when blood clots form in the large veins in the leg (or, less frequently, the arms, pelvis, or other parts of the body). Clots caused by DVT restrict blood from returning to the heart, and often results in pain and swelling at the area of the clot.
Symptoms of a Blood Clot
Blood clots on their own can cause a variety of symptoms that do not seem life-threatening at first, which is why many people delay emergency treatment and suffer major complications. Symptoms of blood clot complications (pulmonary embolism, heart attack, stroke, and more) usually produce sudden, catastrophic symptoms because the blood clot has caused a blockage of a main artery in an organ.
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
Blood clots do not always cause symptoms. Around 50% of blood clots caused by DVT are symptomless.
Gianvi Side Effects
Gianvi side effects include, but are not limited to:
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Pulmonary Embolism (PE)
- Abnormal heart rhythm
- Heart Attack
- Myocardial Infarction
- Gallbladder injury