As one of the newest contraceptives in Bayer’s arsenal, Safyral (generic: drospirenone, ethinyl estradiol, and levomefolate) dramatically reduces the risk of women becoming pregnant. However, the addition of an extra ingredient also helps to prevent the development of certain birth defects that may result from Safyral use. Unfortunately, recent studies suggest that Safyral treatment may correspond with dangerous side effects. Women who use Safyral may increase their risk of developing severe blood clots and any subsequent complications that may arise from them.
If you or a loved one has been injured by Safyral, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Safyral Lawsuit Overview
Continuing with the illustrious reputation of Bayer Healthcare products, Safyral was approved by the U.S. Food and Drug Administration (FDA) in 2010. Indications on Safyral labeling acknowledge that the contraceptive is approved to assist in the prevention of unwanted pregnancy. However, the birth control pill is also indicated for the treatment of symptoms associated with premenstrual dysphoric disorder (PMDD) and moderate acne.
Safyral combines three unique active ingredients, drospirenone, ethinyl estradiol, and levomefolate. Both drospirenone and ethinyl estradiol work together to prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. The introduction of levomefolate, a B vitamin, helps prevent a rare birth defect that could occur from the high folate levels created by Safyral.
When used as directed, Safyral has proven to be 99% effective in preventing pregnancy. However, recent evidence lends weight to the long-suspected link between drospirenone-containing contraceptives and catastrophic complications. According to a recent FDA Advisory Committee, the introduction of drospirenone may be responsible for the development of severe blood clots known as deep vein thrombosis (DVT). If these should develop, women would be at an increased risk of several complications including: heart attack, stroke, pulmonary embolism, abnormal heart rhythm, gall bladder injury and pancreatitis. Due to the severe nature of these complications, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Safyral lawsuit.
Of the Safyral lawsuits currently pending against Bayer, plaintiffs most often experienced the following complications:
- Heart attack
- Deep vein thrombosis (DVT)
- Heart arrhythmia
- Gallbladder disease
- Pulmonary embolism
FDA Safety Communication
According to an FDA Safety Communication, the agency is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. Unfortunately, the presence of a severe VTE may lead to the development of several life-threatening complications.
Safyral Label Change to Include Risk of Blood Clots
The FDA has recently completed a review of observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on the data acknowledged in the review, officials at the FDA have concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. To put the risk of developing a blood clot from a birth control pill into perspective: The risk of developing a blood clots is higher when using any birth control pills than not using them. As a result, the FDA has requested a label change.
According to a Drug Safety Communication, the revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins.
Other Fourth Generation Contraceptives
The following fourth generation contraceptives contain drospirenone and may also significantly increase the risk of severe, life-threatening complications:
Do I Have a Safyral Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Safyral lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Safyral, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.