Founding Partner
On March 13, 2020, the European Medicines Agency’s (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), recommended that women stop taking 5 mg ulipristal acetate for uterine fibroids until the results of a safety review examining ulipristal acetate side effects.
Ulipristal acetate is sold in the United States under the brand name Ella and under the generic name Ulipristal. In Europe, ulipristal acetate was approved and is marketed under the brand names Esmya and EllaOne. According to the new EMA guidelines, it is recommended that no new patients are prescribed these medications and sale of these drugs is suspended in the European Union until further notice. The Ella birth control side effects are too serious and too dangerous for doctors to continue prescribing the drug.
In 2018, the European Medicines Agency initiated a review of ulipristal acetate medicines taken to treat uterine fibroids. The safety review was initiated due to reports of serious liver injury in women prescribed ulipristal acetate to treat uterine fibroids. The review’s findings concluded that there is a rare risk of severe liver damage associated with ulipristal acetate medications. Safety measures were then put into place to protect patients prescribed ulipristal acetate.
The European Medicines Agency initiated a new review and subsequently suspended Esmya, EllaOne, Ella, and other ulipristal acetate medications due to a recent liver injury case in which the patient was required to undergo a liver transplant. This new case was of serious concern, because the measures put into place in 2018 were adhered to, but the patient suffered severe liver damage and required a liver transplant anyway. Approximately 900,000 women have been treated for fibroids with ulipristal acetate medications since 2012, and five women have required a liver transplant, according to the European Medicines Agency.
Ulipristal acetate is approved in both Europe and the United States as a single-dose, emergency contraceptive. This new EMA safety review will not target single-dose ulipristal acetate used for emergency contraception. At this time, the EMA states that there are no concerns about ulipristal acetate liver damage in this application. However, the U.S. Food and Drug Administration has not made any statements regarding the risks associated with ulipristal acetate drugs and these drugs have not been approved in the United States to treat uterine fibroids.
Parker Waichman LLP is offering a free consultation to women who have taken Ella or other ulipristal acetate medications and suffered liver injury, liver damage or the need for a liver transplant after taking ulipristal acetate for fibroids. Side effects such as these could be grounds for a personal injury lawsuit. If you took the drug and experienced any of these ulipristal acetate side effects, contact us now.
The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) advises health-care providers to take the following steps:
If you have taken Ella or another form of ulipristal acetate and suffered a liver injury, you may be able to get compensation. However, the time you have to recover monetary compensation for ulipristal acetate liver damage is limited by state and federal law, so it’s essential that you act quickly.
You can count on Parker Waichman LLP to manage your case professionally and promptly: We are a nationally recognized defective drug litigation law firm with decades of experience representing patients harmed by defective medications. Parker Waichman LLP has helped clients to collect more than $2 billion in monetary compensation, and our legal professionals will work hard for you or your loved one. Our product liability lawyers have the experience to fight the big pharmaceutical companies on your behalf, and we are ready to fight for full monetary compensation for those who have ulipristal acetate liver damage
If ulipristal acetate (Ella) has harmed you or a member of your family and you are interested in filing a lawsuit to recover monetary compensation, contact Parker Waichman LLP by calling 800-968-7529 for a free case review today.
Parker Waichman LLP
If you or a loved one has been injured in an accident or have been injured by another party in some other way, we are here to stand up for your rights. Our personal injury attorneys have been representing injury victims and their families in Long Island and throughout the nation since the early 1980s.
Our law firm is ready to represent you in your injury case. We’ve helped many New York residents as well as those needing help nationwide. Contact our team for a free case consultation today.
I had a great experience with them , everyone was very helpful and sweet.
Michelle Murphy
4 months ago
Zarahi was very professional and very Quick and very knowledgeable i realy appreciated her patience and perseverance she Deserves 100 stars 🌟 but since i can only send 5 i Guess i will just have to send that truly yours Rashine Downs
Kush Three
6 months ago
VERY NICE WORK PLACE THEY HAVE BEEN GOOD TO MY MOM
Whitney Brinson
5 years ago
They treated me with tender love and care
Terrell Weaver
2 months ago
Wonderful people. They made the whole process if dealing with a gov’t agency so easy. Special compliments to Gina Viti
Michael Ross
2 months ago
I’m a 9/11 first responder, and I can honestly say that Parker Waichman made me feel like they had my best interest in my VCF case. Ms Candalino & Ms Viti are top notch in my book. I was constantly informed on the status of my case. I would definitely recommend Parker Waichman LLP to family and friends.
D D
6 years ago
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
Parker Waichman LLP
27299 Riverview Center Boulevard, Suite 108
Bonita Springs, FL 34134
We handle mass torts cases nationwide. Please contact our office to learn more.