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.
What Are the Concerns With Ella/Ulipristal Acetate?
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.
Do You Have Grounds for
an Ella Lawsuit?
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.
What Should Patients and Their Doctors Do Now?
The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) advises health-care providers to take the following steps:
- Speak to patients currently taking ulipristal acetate for uterine fibroids as soon as possible and halt this treatment. Consider appropriate, alternative treatment options.
- Advise patients to report symptoms and signs of liver injury as soon as possible. When taking ulipristal acetate for fibroids, side effects may include vomiting, nausea, anorexia, right upper quadrant pain, jaundice, and asthenia.
- Perform liver function testing, as described in the product information for those medications, every two to four weeks after the treatment has ended.
- Do not initiate uterine fibroids treatment using ulipristal acetate for any new patient.
- The EMA plans to send a direct communication from health professionals (DHPC) to providers who dispense ulipristal acetate on or shortly after March 23, 2020. The DHPC will also be published on a dedicated page on the EMA website.
- The EMA stated that more updated recommendations and further information on ulipristal acetate for uterine fibroids will be provided following the conclusion of the safety review.
Protect Your Health, Then Protect Your Legal Rights With an Ella Contraceptive Lawsuit
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 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 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 by calling 1-800-YOUR-LAWYER (1-800-968-7529) for a free case review today.