The FDA has recently warned that the drospirenone, an ingredient in Safyral birth control pills, is associated with a higher risk of blood clots compared to other birth control pills. Women who develop a Safyral blood clot may suffer a pulmonary embolism, heart attack (myocardial infarction), ischemic stroke, or death.
Safyral is a birth control pill. It is essentially Yasmin plus folic acid. Safyral was invented by the pharmaceutical company Bayer (the company that created Yasmin), and it was approved by the U.S. Food and Drug Administration (FDA) in December 2010.
The Safyral regimen consists of 21 orange “active” tablets, which contain a combination of synthetic hormones and folate. There are also 7 light-orange “inactive” tablets, which do nothing except help a woman stay in the habit of taking Safyral every day. When used as directed, Safyral is more than 99% effective at preventing pregnancy.
The “active” tablets in Safyral contain the following ingredients:
- 0.451-mg folate B-vitamin: This ingredient is intended to reduce the risk of birth defects in babies born to women who accidentally get pregnant while taking Safyral
- 3-mg drospirenone: This ingredient is a new type of synthetic progestin, and is the cause of Safyral blood clots
- 0.03-mg ethinyl estradiol: This ingredient is a type of synthetic estrogen with a long history of use in medication
Why does Safyral contain folate?
The folate vitamin in Safyral is intended to reduce the risk of birth defects in babies born to women who accidentally get pregnant while taking Safyral.
The FDA recommends that all women of childbearing age take a folic acid supplement (at least 0.4-mg), even if they are not intending to become pregnant. The reason is because doctors know that several of the most severe neural tube birth defects (such a spina bifida or anencephaly) are caused by folic acid vitamin deficiencies. Because neural tube defects occur during the first couple weeks of pregnancy, before most women are aware of a pregnancy, it is important that a woman have adequate folic acid levels before the pregnancy occurs. Sometimes, despite hormonal birth control pills, women get pregnant anyway.
Safyral Blood Clot Lawsuits
Do you have a Safyral blood clot lawsuit? If you were injured by Safyral, you are not alone. Bayer is now facing more than 11,000 lawsuits brought by women who were injured by birth control pills containing drospirenone. Some of these lawsuits are brought on behalf of women who died after taking a drospirenone-containing birth control pill. Blood clots caused by Safyral can cause a life-threatening heart attack, stroke, or pulmonary embolism, which can cause death.
The problem is that drospirenone has been linked to a higher risk of blood clots compared to other types of synthetic progestins, but most women were unaware of this risk when they decided to take Safyral or another drospirenone-containing birth control pill. It is also possible that many women were misled by a massive marketing campaign that promoted drospirenone-containing contraceptives such as Yaz and Yasmin. The FDA sent three warning letters, in 2003, 2008, and 2009, because the ads were “misleading” because they “fail to communicate any risk information.”
If a pharmaceutical company is guilty of failing to warn consumers about the risk of side effects, a judge could force them to financially compensate people who have been injured. Financial compensation could cover medical bills, pain, suffering, decreased quality of life, permanent disability, lost income or earning potential, psychological damage, loss of life, and more.
Safyral Side Effects
Safyral has been linked to the following list of 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