Drospirenone, an ingredient in Safyral, has recently been linked to a higher risk of blood clots, compared to other birth control pills. Women who get blood clots may suffer severe, life-threatening side effects, which may include pulmonary embolisms, heart attack, stroke, or 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.
Safyral is a hormonal birth control pill, essentially the same as Yasmin, but with an added folate B-vitamin. Safyral is sold by the pharmaceutical company Bayer, and the U.S. Food and Drug Administration (FDA) approved it in December 2010.
Like many oral contraceptives, Safyral consists of “active” and “inactive” pills. The active pills in Safyral are orange, and contain a combination of two hormones (synthetic progestin and estrogen) and a folate vitamin. The “inactive” pills are light-orange and do not contain drugs, but they do help a woman keep a habit of taking a birth control pill at the same time every day.
Each “active” Safyral pill contains these ingredients:
- 0.451-mg folate metabolite, which is a B-vitamin dietary supplement. This ingredient helps reduce the risk of birth defects in babies born to women who accidentally become pregnant.
- 3-mg drospirenone, which is a new type of synthetic progestin
- 0.03-mg ethinyl estradiol, which is a type of synthetic estrogen
Why does Safyral contain folate?
Safyral contains a folate B-vitamin to lower the risk of neural tube birth defects (such as spina bifida) if a woman gets pregnant on Safyral.
Though rare, sometimes women do get pregnant while taking Safyral. Pregnancy is most common when women do not take Safyral as directed (at the same time every day), though pregnancy can also occur if Safyral is taken exactly as directed. The FDA recommends that all women who are sexually active and of childbearing age consume a folate dietary supplement. Researchers have discovered that most neural tube birth defects (spina bifida, anencephaly, and more) are caused by a folate vitamin deficiency. These severe, life-threatening birth defects occur in the first few weeks of pregnancy. Most women do not know they are pregnant at this time. Therefore, it is crucial that a woman should have normal folate levels before getting pregnant.
Safyral Blood Clot Lawsuits
If you were injured by Safyral, you may have a Safyral blood clot lawsuit. Thousands of women have been injured by blood clots after taking a drospirenone-containing birth control pill, including Safyral. The litigation against Bayer involves more than 11,000 injury lawsuits. The litigation also includes lawsuits for deaths caused by Bayer’s birth control pills.
The problem is that drospirenone, an ingredient in Safyral, has been linked to a significantly higher risk of blood clots compared to other combination-hormonal birth control pills. The FDA has recently issued an official warning about this risk. The FDA has also been concerned about the way Bayer marketed drospirenone-containing birth control pills, such as Yaz and Yasmin. In three warning letters (sent in 2003, 2008, and 2009), the FDA called the ads “misleading” because they “fail to communicate any risk information.” The ads also implied that Yasmin was safer than other birth control pills and misled consumers about what the FDA approved the drugs to treat.
Most injury lawsuits against pharmaceutical companies are “failure to warn” lawsuits, brought by people who were injured because they were not adequately warned about a side effect before taking a medication. If a judge finds a company guilty of failing to warn about side effects, the company could be held financially liable for the injuries caused by their medication.
Safyral Side Effects
Safyral has been linked to the following side effects:
- Blood clots
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Pulmonary embolism
- Heart attack (myocardial infarction)
- Gallbladder disease
- Hyperkalemia (toxic high levels of potassium)
- Irregular heartbeat (heart arrhythmia)
- Psychological trauma
Do I have a Safyral Lawsuit?
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