Safyral is a new type of oral birth control medication that contains drospirenone, and has recently been linked to an increased risk of blood clots, pulmonary embolisms, heart attack, stroke, gallbladder disease, and other serious side effects, including death.
Do I Have a Safyral Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by blood clots, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
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 Safyral?
Safyral is an oral birth control pill that combines Yasmin with a folate B-vitamin. Safyral belongs to the “fourth generation” of oral birth control medications that includes Yaz, Yasmin, Ocella, Beyaz, Zarah, Loryna, Gianvi, and Syeda.
Safyral is a once-a-day medication, consisting of 21 active orange tables and seven inactive tablets. The active tablets contain the following ingredients:
- 3 mg drospirenone (synthetic progestin)
- 0.03 mg ethinyl estradiol (synthetic estrogen)
- 0.451 mg levomefolate calcium (folate)
The inactive tablets help a woman stay in the habit of taking Safyral at the same time every day, which increases its effectiveness. When taken as directed, Safyral is more than 99% effective at preventing pregnancy. It does so by preventing ovulation (when the ovaries release an egg), changing the cervical mucus (making it difficult for sperm to enter the uterus), and also changing the lining of the uterus — so even if the ovaries release an egg, and a sperm fertilizes the egg, it will have difficultly implanting in the uterine wall and growing.
Why does Safyral contain folate?
Safyral contains 0.451 mg of levomefolate calcium (a folate B-vitamin). The Centers for Disease Control (CDC) recommends that women of childbearing age take a vitamin with at least 0.4 mg of supplemental folic acid every day. Safyral contains slightly more than the recommended daily amount. Low levels of folic acid have been linked to severe neural tube birth defects, such as spina bifida). Taking a folate supplement can greatly reduce the chance that these birth defects will occur.
What is the problem with Safyral?
Safyral contains drospirenone, which is a newly-developed type of synthetic progestin. Progestin is a female sex hormone. Most oral birth control combines synthetic progestin and estrogen. Older forms of synthetic progestin (such as levonorgestrel) have been studied extensively, and although they have been linked to an increased risk of developing a blood clot, the risk is low. With new birth control containing drospirenone, however, the risk of developing a blood clot and other deadly thromboembolic events may be significantly higher than previously expected.
What are my chances of developing a blood clot if I take Safyral?
All birth control pills increase a woman’s chance of developing a blood clot. However, several new studies have compared older forms of oral birth control pills with new pills that contain drospirenone, such as Safyral. The findings have prompted the FDA to issue several safety warnings.
- FDA Safety warning May 31, 2011
- FDA Safety Warning September 26, 2011
- FDA Safety Warning October 27, 2011
These warnings are in response to several studies which have found that drospirenone may be significantly more likely to cause blood clots than another form of synthetic progestin, known as levonorgestrel.
- In 2011, two articles published in the British Medical Journal reported a two- to three-fold greater risk of thromboembolic events (including blood clots, deep vein thrombosis, and pulmonary embolisms) in women using an oral contraceptive containing drospirenone
- In 2009, two other publications found that women who take drospirenone-containing contraceptives may be at a 1.5- to 2-fold greater risk than other forms of oral contraceptives.
- In November 2011, a massive study in Israel found that the risk of developing a blood clot may be 40% higher. The researchers studied 329,995 women taking oral contraceptives
FDA Study of Drospirenone
The FDA conducted its own study, following nearly 800,000 women. This was by far the largest study comparing drospirenone-containing contraceptives to other oral contraceptives. The FDA found that women have at least a 1.5-fold increased risk of developing a blood clot while using a contraceptive containing drospirenone. The risk is greatest for women in their first year of taking the medication, and even more increased for women who smoke and are over 35 years of age.
Safyral Side Effects
Drospirenone may increase the levels of potassium in a woman’s bloodstream too much. This causes the blood to coagulate more easily, especially in the large arteries in the extremities (usually the legs). This is called Deep Vein Thrombosis (DVT). Blood clots caused by DVT usually resolve on their own, or cause no symptoms. Occasionally, however, blood clots may break loose and travel through the bloodstream. This is called an embolism. Embolisms are one of the most dangerous side effects of using Safyral. If an embolism travels to a major internal organ (such as the brain, heart, lungs, or other organ), it may become lodged in the artery that supplies blood to these organs. This is how side effects such as stroke, cerebral hemorrhage, heart attack, and pulmonary embolism are caused. During a Pulmonary Embolism, an embolism becomes trapped in the lungs. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.
Symptoms of a Blood Clot
Blood clots may have no symptoms.
Symptoms of a blood clot may include pain in the extremities, swelling, numbness, a “tingling” feeling, slurred speech, and blurred vision. If you experience any of these symptoms, you should contact an emergency physician immediately. Blood clots caused by Safyral can lead to more serious complications, including death.
Other Possible Side Effects
- Idiopathic Intracranial Hypertension
- Pseudotumor Cerebri
- Irregular uterine bleeding
- Liver disease
- Gallbladder disease
Do I have a Safyral Lawsuit?
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