One serious side effect of Gianvi is Deep Vein Thrombosis (DVT), a condition that occurs when blood clots form in veins deep inside the body, most commonly inside the legs. The risk is that the blood clot could break loose, travel through the bloodstream, and cause a pulmonary embolism, heart attack, stroke, or death.
Gianvi Overview
Gianvi (drospirenone / ethinyl estradiol) is a hormonal birth control pill manufactured by Teva Pharmaceuticals. It was approved in 2010 by the U.S. Food and Drug Administration (FDA) for the prevention of pregnancy, treatment of mild acne, and Premenstrual Dysphoric Disorder (PMDD). Gianvi is a generic form of Yaz, and both medications contain the same amount of active ingredients, which are:
- Drospirenone (0.3 milligrams): A new, “fourth generation” version of synthetic progestin, first introduced in the mid-2000s. Post-marketing research suggests that drospirenone has a slightly higher risk of DVT and blood clots, compared to older generations of synthetic progestin.
- Ethinyl estradiol (0.02 milligrams): Synthetic estrogen, a female reproductive hormone. It has been used in medicine since the 1940s and has a long history of safe use.
The controversy regarding Gianvi and Yaz stems from drospirenone, a new type of synthetic progestin. Though all birth control pills increase a woman’s risk of developing DVT and blood clots, the risk with older generations of synthetic progestin was around 4-6 cases per 10,000 women taking the medication. With drospirenone, however, the risk is around 10 women per 10,000 taking the medication.
When the first “fourth generation” contraceptives were introduced into the U.S. market, the manufacturers advertised them without any risk information, and claimed that they could also improve a woman’s quality of life (reducing acne and treating symptoms of PMS). Yaz became the most popular oral contraceptive in 2008 and 2009. In two warning letters sent in 2008 and 2009, the FDA called the advertising campaign “misleading,” and Bayer ran a corrective advertising campaign.
However, by this time, tens of millions of women decided to switch from older types of oral birth control to the newer types of birth control. Though the new pills were no more effective at preventing pregnancy, and were not approved to treat all acne or PMs, they did have a slightly higher risk of developing blood clots. An extra 4-6 cases of blood clots per 10,000 women, multiplied by tens of millions of users, equals thousands of extra cases of blood clots and DVT.
What is Deep Vein Thrombosis (DVT)?
Deep Vein Thrombosis (DVT) is a life-threatening condition that occurs when a blood clot (or “thrombus”) forms in a large vein in the body. It most commonly occurs in the large veins in the legs or thighs, but can also form in the arms or the pelvis. Blood clots that form close to the skin (such as varicose veins) remain in place and do not cause side effects. With DVT, however, blood clots form inside veins deep inside the body.
DVT is one of the leading causes of Pulmonary Embolisms, which are caused by blood clots that form in the legs, break free from their origin, and travel through the bloodstream. They travel through the body, into the right side of the heart, which normally pumps oxygen-deprived blood from the body into the lungs, where it can become oxygenated. Unfortunately, when a blood clot is pumped into the lungs, it is too large to fit in the small blood vessels in the lungs. It becomes stuck, and prevents blood from reaching the lung tissue. 30% of untreated pulmonary embolisms result in death.
Signs & Symptoms of Deep Vein Thrombosis (DVT)
Blood clots formed by Deep Vein Thrombosis (DVT) do not always have symptoms. Around 50% of cases do not show any signs, usually because the clot is small and deep inside the body. Symptomless blood clots can still cause deadly side effects. However, if DVT does show symptoms, it is usually because the clot is large, and is having an effect on circulation. Symptoms of a blood clot in the legs include:
- Swelling (edema) of the leg, sometimes along a vein
- Pain, tenderness in the leg
- Pain that gets worse while standing or walking
- Warmth in the area of the leg that is swollen or painful
- Redness in the affected area, or changes in skin color
Gianvi Side Effects
- Depression
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Pulmonary Embolism (PE)
- Hyperkalemia
- Stroke
- Abnormal heart rhythm
- Heart Attack
- Myocardial Infarction
- Gallbladder injury
- Pancreatitis
- Death
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