As an additional medication on the vast market of oral contraceptives, Beyaz (generic: drospirenone, ethinyl estradiol and levomefolate) is unique. While indicated for the prevention of pregnancy, Beyaz also uses a third ingredient that assists in reducing the risk that a child will develop a rare birth defect. However, recent studies suggest that the introduction of a Beyaz regimen may coincide with catastrophic problems. Women who use Beyaz may increase their risk of developing severe, life-threatening complications such as heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism and blood clots.
If you or a loved one has been injured by Beyaz, 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.
Beyaz Lawsuit Overview
As the newest addition to Bayer’s arsenal of oral contraceptives, Beyaz was introduced to the U.S. market on September 24, 2010. Prior to its release, Beyaz was approved by officials at the U.S. Food and Drug Administration (FDA) to prevent pregnancy in women. Beyaz is also indicated for the treatment of moderate acne and the symptoms of premenstrual dysphoric disorder (PMDD).
Beyaz contains a combination of drospirenone, ethinyl estradiol, and levomefolate. Drospirenone and ethinyl estradiol 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. Levomefolate is a type of B vitamin that is normally found in foods. Levomefolate helps prevent a rare birth defect that could occur in a baby if the pregnancy occurs while taking birth control pills or shortly after stopping them.
When taken as directed, Beyaz has shown a 99% success rate. However, the introduction of drospirenone-containing contraceptives may coincide with dangerous results. According to a recent FDA Advisory Committee, drospirenone-containing contraceptives may heighten potassium levels. Significantly elevated potassium levels may result in the development of severe blood clots, otherwise 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 Beyaz lawsuit.
Beyaz Side Effects
The following is a comprehensive list of the side effects that have been associated with Beyaz treatment:
- Breast tenderness
- Bleeding between menstrual periods
- Stomach cramps
- Weight gain
- Severe allergic reactions
- Breast discharge
- Calf or leg pain
- Irregular heart beat
- Breathing difficulties
- Chest pain
While these side effects do not pose as life-threatening, they may be indicative of more severe complications.
Of the Beyaz 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.
Beyaz 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 Beyaz 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 Beyaz lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Beyaz, 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.