EMA Concludes Its Review on Esmya

Back in December 2017 the European Medicines Agency announced that it had started an in-depth review on Esmya (ulipristal acetate), a drug widely used to treat fibroids. This in-depth review was conducted following four reports of serious injury with three of these patients having to have a liver transplant. After receiving these reports an initial assessment of these cases was carried out and it was determined that Esmya was indeed the cause of the liver damage, therefore the EMA started a more comprehensive review.

The EMA has now concluded its review on Esmya and in June 2018 published new measures to minimise the risk of rare but serious liver injury that could be caused by Esmya. They recommended that the use of Esmya be restricted and that more research be conducted to gain a better understanding of how Esmya effects the liver and whether the measures they have introduced will, in fact, be effective at minimising the risk of liver damage.

EMA’s Safety Measures for Esmya

The specific measures that the EMA has introduced are:

Esmya should not be prescribed to patients who have liver problems
A liver test should be performed before a patient starts taking Esmya and if the test is abnormal the drug should not be prescribed
Patients should have liver tests during and after treatment
If no liver problems are detected, a single course of Esmya can be used in women who are about to have surgery for their fibroids; Esmya can be used for more than one course only in women who cannot have surgery
A card should be included in the package for Esmya with information on the risk of liver damage and the need for liver monitoring
Patients should stop treatment and contact their doctor immediately if they develop symptoms of liver injury, which include tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting
Patients with questions or concerns about their treatment should speak to their doctor or pharmacist.