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MHRA imposes restricted indications on Esmya for uterine fibroids

New restricted indications on prescribing Esmya (ulipristal acetate) for symptoms of uterine fibroids put in place by the UK’s medicines watchdog now replace instructions that the drug should not be prescribed to any new patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced that Esmya is now indicated for the intermittent treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age who are not eligible for surgery and for one course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The drug is contraindicated in women with underlying liver disorders and treatment is only to be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids, the MHRA said.

With immediate effect the drug should not be used unless:

  • The new restricted indication is met, and the patient does not have an underlying liver disorder; more than one treatment course is now authorised only in women who are not eligible for surgery;
  • Liver function monitoring is performed before, during and after treatment courses; and
  • The rare risk of liver damage and need for liver function monitoring have been discussed and the patient knows the signs and symptoms of liver injury and what to do if they occur.

The news follows the completion of an EU review investigating the link between the drug and serious liver injury. The restrictions replace instructions issued in February that no new patients should be prescribed the drug.

The MHRA stressed that, despite containing a single 30mg dose of ulipristal acetate, there are no reported cases of serious liver injury in relation to the emergency hormonal contraceptive EllaOne. There are therefore currently no concerns or changes to its use, the watchdog added.