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  • EMA says no new patients should be started on Esyma for uterine fibroids

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    Tuesday, 13 February 2018 12:18
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Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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a pharmacist woman consultationFebruary 13 2018

Doctors should not initiate Esyma (ulipristal acetate) in women with uterine fibroids for the time being, the European Medicines Agency has advised.

Its Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation, said the EMA. “No new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.”

In addition, women taking Esmya for uterine fibroid should have regular liver monitoring. “All women taking Esmya should have a liver function test at least once a month during treatment. If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. Liver tests should be repeated 2 to 4 weeks after stopping treatment.

“For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately. If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.”

The MHRA has also issued advice via the Central Alerting System advising of the PRAC recommendations. It points out: “The emergency contraceptive ellaOne also contains ulipristal acetate (single-dose, 30mg). No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.”

The PRAC’s final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion.

Links:  
EMA announcement    
MHRA CSA announcement       

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