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  • MPS advises of need for better awareness of cauda equina red flag symptoms

    MPS advises of need for better awareness of cauda equina red flag symptoms

    Wednesday, 09 May 2018 16:01
  • Anticholinergics linked to increased risk of dementia

    Anticholinergics linked to increased risk of dementia

    Monday, 30 April 2018 12:20
  • Women of childbearing potential must be on Pregnancy Prevention Programme if taking valproate

    Women of childbearing potential must be on Pregnancy Prevention Programme if taking valproate

    Friday, 27 April 2018 12:12
  • Buprenorphine may be safer than methadone in opioid substitute therapy, study suggests

    Buprenorphine may be safer than methadone in opioid substitute therapy, study suggests

    Monday, 23 April 2018 16:59
  • Class of diabetes drug linked to increased risk of irritable bowel disease

    Class of diabetes drug linked to increased risk of irritable bowel disease

    Thursday, 29 March 2018 11:49

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 a ‘Dear Doctor’ letter 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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