Following a licensing and supply agreement by Bayer Healthcare, select drug manufacturers are now able to develop and market their own variation of generic Yasmin (drospirenone and ethinyl estradiol) products despite the existing patent. Similar to that of Yasmin, generic birth control variations introduced by Barr and Teva are indicated to assist in the prevention of pregnancy. However, recent studies suggest that these oral contraceptives may coincide with the development of serious side effects. Drospirenone-containing contraceptives, such as generic Yasmin products, may increase a woman’s risk of developing life-threatening blood clots and any complications that may ensue.
If you or a loved one has been injured by generic Yasmin, 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.
Generic Yasmin Lawsuit Overview
Yasmin, an established component of Bayer’s oral contraceptive arsenal, received U.S. Food and Drug Administration (FDA) approval on May 11, 2001. Shortly after receiving the FDA’s approval, Yasmin was released into the U.S. market to assist in the prevention of pregnancy. Approximately seven years later, Bayer entered into a supply and licensing agreement with Barr Laboratories, a subsidiary of Teva Pharmaceuticals. According to the terms of their agreement Bayer will supply Barr with the generic products for launch prior to the expiration of the patents protecting these products and Barr will have sole responsibility to market, sell and distribute the products in the U.S. under the Barr Laboratories label. In return, Bayer receives a portion of the profits.
Following the agreement, both Teva and Barr released their variation of generic Yasmin products. Teva released Ocella in 2008, while Barr released Gianvi in 2010. Each of these oral contraceptives contained the same ingredients as Yasmin and were indicated by the FDA for the same uses.
These forms of generic Yasmin are what many consider to be a fourth generation contraception, due to the ingredients contained within. Drospirenone, unique to fourth generation contraception is a progestin with the ability to prevent the ovulation process in women by altering conditions in the cervical and uterine lining. Combination oral contraceptives (COCs) such as these act by suppressing gonadotropins. Although the primary mechanism of this action is the inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation). As a result, these altered conditions make it more difficult for any sperm to reach the uterus. Therefore serving as an affective form of birth control.
While each has demonstrated the ability to prevent pregnancy, treatment with generic Yasmin contraceptives has been associated with serious side effects. Of significant concern, are the elevated blood potassium levels that may coincide with generic Yasmin treatment. According to a recent FDA Advisory Committee, drospirenone-containing contraceptives may increase potassium levels beyond that of which is considered safe. Furthermore, elevated potassium levels may initiate the clotting cascade responsible for the development of blood clots. The formation of an unnecessary blood clot may prevent organs from receiving their required nutrients, resulting in several severe, life-threatening complications. Due to the severity of these clots, women may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential generic Yasmin lawsuit.
Complications in Generic Yasmin Lawsuits
While the clotting cascade remains a necessary defense against the excessive displacement of blood, the formation of an unnecessary blood clot may prove to be dangerous. In the event that a clot inhibits the proper flow of blood throughout the circulatory system, serious side effects may arise. The following complications are currently being reviewed in generic Yasmin lawsuits:
- Heart attack
- Deep vein thrombosis (DVT)
- Heart arrhythmia
- Gallbladder disease
- Pulmonary embolism
Generic Yasmin 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. If you have taken these forms of birth control and are worried about blood clot risks, you may be entitles to compensation by filing your own generic Yasmin lawsuit.
Generic Yasmin Contraceptives
The following fourth generation contraceptives contain drospirenone and may also significantly increase the risk of severe, life-threatening complications:
Do I Have a Generic Yasmin 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 generic Yasmin lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by generic Yasmin, 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.