Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Esmya (ulipristal acetate) is indicated for the treatment of severe symptoms caused by uterine fibroids -- or noncancerous growths in the uterus -- in women of reproductive age.
While Esmya is currently available in Europe, it is still pending FDA approval in the U.S.
The active ingredient, ulipristal acetate is the same as that of Ella, an emergency birth control medication that is approved in the U.S. However, a key difference between the two medications is the dose amount and frequency. While Ella is a 30mg tablet meant to be used once, Esmya is a 5mg tablet to be used once daily for treatment courses of up to 3 months each.
Reports of Severe Liver Injury
The European Drug Label for Esmya lists "Hepatic impairment" in the "Special warnings and precautions for use" section.
Here is an alarming excerpt from this section:
During the post-marketing experience, cases of liver injury and hepatic failure were reported. During treatment, liver function tests should be performed at least monthly. In addition liver testing 2- 4 weeks after treatment has stopped is recommended. If a patient shows signs or symptoms compatible with liver injury (nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice, etc.), the patient should be investigated immediately, and liver function tests performed.
Four cases of severe liver injuries in patients using the drug have already been reported to the European Medicines Agency (EMA), three of which resulted in liver transplants.
In December 2017, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) began their investigation of the association between Esmya and liver failure.
They provide the following information in their investigation announcement letter:
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has made an initial assessment of the cases of liver injury and considered that Esmya could be the cause.
Given the seriousness of the observed liver injury and its possible link to the medicine, a more in depth review is warranted.
While the investigation is still underway, the EMA has advised healthcare providers to refrain from initiating treatment with Esmya. They also encouraged doctors to closely monitor the liver function of patients already taking the drug to see if stopping treatment is necessary.
We will continue to monitor the medical literature here and abroad for developments in the PRAC's investigation of Esmya, and report accordingly.
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