Esmya (Ulipristal Acetate 5 mg): Risk of Serious Liver Injury

Drug Safety Update

Esmya (Ulipristal Acetate 5 mg) was approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Rare but serious cases of liver injury and hepatic failure requiring liver transplantation have been reported worldwide in women treated with Esmya for symptoms of uterine fibroids.

Recommendations

The product registration of Esmya was withdrew in Malaysia and therefore, Esmya will no longer be available and women previously receiving Esmya should be advised on alternative therapy.

NOTE: The risk is not related to Ella Tablet (Ulipristal acetate 30 mg), which is used for emergency contraception.

External Links

• Ulipristal acetate as a treatment option for uterine fibroids, 2017
  
• Esmya (ulipristal acetate 5 mg): Withdrawal of product registration, 2020
  
• Ulipristal acetate for uterine fibroids: EMA recommends restricting use, 2020