UK Medicines Information
Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
Information type:
Safety alerts
Source:
Medicines and Healthcare products Regulatory Agency
Specialities:
Liver disorders | Obstetrics and gynaecology
Summary
The March edition of the Drug Safety Update newsletter discusses temporary safety measures introduced to protect women’s health whilst a safety review of this product is ongoing. The EU-wide review was initiated in December 2017 following reports of serious liver injury.
UKMi comment
The Company have issued a Direct Healthcare Professional Communication regarding the safety review and the temporary measures that have been put in place regarding prescribing and monitoring.
Related links:
Letter