MHRA Recalls Uterine Fibroids Medication

Dawn O'Shea

March 20, 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) is recalling ulipristal acetate (Esmya, Gedeon Richter UK) 5 mg tablets used in the treatment of uterine fibroids.

The decision follows confirmation of a new case of liver failure requiring liver transplant in a patient taking Esmya. The drug was also suspended by the European Medicines Agency.

The MHRA advises that health care professionals should stop prescribing Esmya or generic ulipristal acetate for the treatment of uterine fibroids.

Health care professionals are advised to contact patients who have been prescribed Esmya and ask them to stop taking the medication as soon as possible, and should be advised to return any unused medicine to their pharmacy.

Patients should be advised to immediately report signs and symptoms of liver injury, such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia and jaundice. These can occur even after stopping the treatment.

Liver function testing should be performed within 2 to 4 weeks after the treatment has been stopped.

The safety of the drug is now being reviewed by the MHRA.

Adapted from Univadis from Medscape.


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