Gianvi has been linked to serious, life-threatening side effects including blood clots, pulmonary embolisms, heart attacks, stroke, and death.
UPDATE
April 2012 — The FDA has recently announced that it will be updating the drug safety information for all birth control pills containing drospirenone. In a statement, they said: “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA will be updating the drug safety information to warn about the increased risk of blood clots associated with drospirenone.
What is Gianvi?
Gianvi is a daily oral contraceptive (“the pill”), approved by the FDA in 2010 to prevent pregnancy, treat moderate acne, and for premenstrual dysphoric disorder (PMDD). It is not approved to treat PMS or severe acne. It is among a new class of contraceptives that contain drospirenone — a synthetic form of progestin. Other contraceptives in this class of medications include Yaz, Yasmin, Ocella, Beyaz, Zarah, Loryna, Safyral, and Syeda.
When used correctly, fewer than 1 out of 100 women who use Gianvi as their primary form of contraception will become pregnant. Gianvi decreases the chances that a woman will conceive by preventing ovulation (when the ovaries release an egg), changing the cervical mucus (making it difficult for sperm to enter the uterus), and changing the lining of the uterus (making it difficult for a fertilized egg to implant and grow).
Is Gianvi the same as Loryna?
The only difference between Gianvi and Loryna are their distributors and FDA approval date. Gianvi, Loryna, and Yaz contain the same amount of active ingredients (progestin/estrogen).
- Gianvi is made by Teva Pharmaceuticals, and was FDA-approved in 2010.
- Loryna is made by Sandoz Pharmaceuticals, and was approved by the FDA in 2011.
Is Gianvi the same as Yaz?
Gianvi is a generic form of Yaz. A “generic medicine” is very similar to its brand-name equivalent. When the patent expires on a brand-name pharmaceutical, other companies may begin to produce the exact same drug, but at a fraction of the price. The FDA requires that generic medicines have the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.
Each active pill contains the following active ingredients:
- 3 mg drospirenone (synthetic progestin)
- 0.03 mg ethinyl estradiol (synthetic estrogen)
Side Effects of Gianvi
Blood clots (arterial thromboembolism) are one of the most serious side effects of using Gianvi. Why? Because they can lead to serious, life-threatening side effects such as:
- Heart attack (myocardial infarction)
- Pulmonary embolisms
- Deep Vein Thrombosis (DVT)
- Cerebral hemorrhage
- Death
Gianvi & Drospirenone
Drospirenone is a new, synthetic form of progestin. All forms of oral birth control contain progestin. The safety of older forms of birth control pills has been established, but studies of drospirenone are ongoing, and some recent findings have raised serious concern.
Drospirenone increases the level of potassium in a woman’s blood, sometimes too much. High levels of potassium can cause the blood to coagulate, particularly in the extremities. This is called Deep Vein Thrombosis (DVT). DVT is a very serious side effect of using Gianvi. If a clot travels through the bloodstream (called an (“embolism“), it may become stuck in the brain, heart, lungs, or other major internal organs. In the most serious cases, it may stop oxygenated blood from reaching these organs. This is called a stroke, and can lead to permanent debilitating injury or death. Seek help immediately if you suspect you have a blood clot. A Pulmonary embolism is when a blood clot blocks the artery leading to the lungs. If untreated, 30% of people who have a PE will die, usually within the first few hours.
What are the symptoms of a blood clot? Talk to your doctor so you can recognize the warning signs of a blood clot — these symptoms may lead to more serious injury. Symptoms may include: swelling, sharp pain in the extremity, numbness, a “tingling” feeling, slurred speech, or blurred vision. Sometimes blood clots resolve on their own. Other times, they are symptomless killers. If you suspect that you may have a blood clot, contact an emergency physician immediately.
Other serious side effects include:
- Irregular uterine bleeding
- Cerebral thrombosis
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
These side effects are significantly increased for women who smoke and are over 35 years of age.
FDA Studies & Safety Warnings
Drospirenone has been linked to an increased risk of blood clots, prompting the FDA to issue multiple safety warnings after reviewing the findings of these studies.
Recently, the FDA has also issued the results of a massive study of 800,000 women taking oral contraceptives. The FDA found that women have at least a 1.5-fold increased risk of developing a blood clot if they are taking drospirenone-containing contraceptive. The risk is greatest for women in their first year of taking the medication.
Other studies have found similar results. In 2009, two independent studies found that a woman may be twice as likely to develop a blood clot while using drospirenone-containing contraceptives. In 2011, two studies published in the British Medical Journal found that a woman may be between 2-3 times more likely to develop a blood clot while taking drospirenone. In November 2011, the conclusions of a massive Israeli study that followed 329,995 women was published. The Israeli study found a 40% increased risk of developing a blood clot while taking a drospirenone-containing contraceptive.
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