Gianvi side effects include Deep Vein Thrombosis (DVT), a life-threatening condition where blood clots develop inside the deep veins in the legs, thighs, pelvis, or other parts of the body. Only around 50% of cases cause symptoms, but all blood clots can cause death. If the blood clot travels in the bloodstream, it can become trapped in a major internal organ. DVT is one of the leading causes of pulmonary embolisms, stoke, heart attack, and death.
Gianvi (drospirenone / ethinyl estradiol) is the generic form of Yaz. Both medications are once-daily, oral contraceptive pills, approved by the FDA to prevent pregnancy, reduce mild acne, and reduce symptoms of a severe premenstrual mood disorder called Premenstrual Dysphoric Disorder (PMDD). Gianvi and Yaz contain the same dosage of active hormones, which includes:
- Drospirenone: Gianvi contains 0.3 milligrams of drospirenone, a “fourth generation” iteration of synthetic progestin, first introduced on the U.S. market in the mid-2000s in Yaz.
- Ethinyl estradiol: Gianvi contains 0.02 milligrams of ethinyl estradiol, a type of synthetic estrogen that has been widely used in medicine since the 1940s.
The controversy surrounding Gianvi, Yaz, and other “fourth generation” birth control pills (Yasmin, Ocella, and more), comes from drospirenone, a new type of synthetic progestin. Older versions of synthetic progestin were known to slightly increase a woman’s risk of developing a blood clot. These older types of synthetic progestin had a long history of use, and the estimated risk of blood clots was relatively small, around 4-6 women per 10,000 taking the hormone. When drospirenone was introduced, researchers quickly found evidence that the risk of blood clots was slightly higher, around 10 per 10,000 women.
The problem is that tens of millions of women decided to switch from the older types of hormonal birth control pills to the “fourth generation” birth control pills — even though the new pills were no more or less effective at preventing pregnancy, and carried a slightly higher risk of blood clots. Their decision to switch was likely influenced by a massive advertising campaign, which the FDA later called “misleading” because the ads “failed to communicate any risk information.” The ads also claimed that the new pills could improve a woman’s quality of life in addition to preventing pregnancy, by reducing all acne and the symptoms of PMS. However, the FDA never approved the new pills to treat these conditions.
Though the absolute risk of developing a blood clot is still small, when a small risk is multiplied over tens of millions of patients, the total number of extra adverse events is in the thousands. Blood clots formed in DVT can be life-threatening, and the FDA is aware of at least 50 women who have died after taking a birth control pill containing drospirenone.
What is Deep Vein Thrombosis (DVT)?
Deep Vein Thrombosis (DVT) is one of the most serious side-effects of using Gianvi. It occurs when a blood clots (or “thrombus”) forms in veins located deep within the body. DVT does not cause veins on the surface of the skin, such as varicose veins, which do not cause serious side effects. Rather, DVT blood clots form in large veins in the extremities. The most common location for a DVT is the lower leg or thigh. However, rarely, DVT also occurs in the large veins in the pelvic region and the arms.
The biggest risk is that a blood clot will form, break free, and be pumped though the bloodstream to the heart. A moving blood clot is called an “embolism.” It can float to the right side of the heart, which receives oxygen-depleted blood from the body, and pumps it into the lungs. If there is an embolism in this blood, it will be too big to fit through the narrow vessels in the lungs. In a life-threatening condition called a Pulmonary Embolism, the blood clot blocks the vessel. The lung tissue quickly becomes starved of blood. Within minutes, lung tissue begins to die. Around 30% of untreated pulmonary embolisms result in death, usually within the first few hours of the event.
Signs & Symptoms of Deep Vein Thrombosis (DVT)
It is estimated that half of all cases of DVT show no symptoms, but even symptomless DVT can still be deadly. When the condition does show symptoms, it is often because there is a large blood clot that is severely disrupting circulation. Blood clots in the legs are the most common, and symptoms 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
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