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Uterine fibroid drug is recalled after case of liver failure requiring transplant prompts EU review

BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m1112 (Published 18 March 2020) Cite this as: BMJ 2020;368:m1112
  1. Elisabeth Mahase
  1. The BMJ

All unexpired stocks of Esmya (ulipristal acetate) 5 mg tablets have been recalled, after a new case of liver failure requiring liver transplant in a patient taking the medicine was reported.

A safety review of the drug by the European Medicines Agency (EMA) is now under way. Doctors have been told to advise patients taking Esmya to stop as soon as possible and to return any unused medicine to their pharmacy. …

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