Overview

The National Pharmaceutical Regulatory Agency (NPRA) would like to inform healthcare professionals regarding the voluntary recall initiated for Esmya 5 mg tablet (ulipristal acetate) [MAL15025044ACZ]. This product recall will be carried out at all points of sales (e.g. hospitals, pharmacies, clinics, specialist centres).

This precautionary measure has been taken in response to new safety concerns on the risk of liver injury associated with Esmya as highlighted by the European Medicines Agency (EMA).

In Malaysia, Esmya is currently the only registered product containing ulipristal acetate 5 mg. Esmya is approved in Malaysia for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age (please refer to the product information for specific indications).

[Note: This risk is not related to another product containing ulipristal acetate, Ella Tablet 30 mg (MAL12035079ACZ), which is used for emergency contraception.]

Background

In response to a recent case of liver injury which led to liver transplantation, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) temporarily suspended the use of ulipristal acetate 5 mg for uterine fibroids. This new case of liver injury had occurred despite the implementation of risk minimisation measures since 2018. The temporary suspension of any prescribing, dispensing of and ongoing treatment with ulipristal acetate 5 mg takes effect immediately until the conclusion of the safety review by EMA, which is estimated to be in September 2020.

Following EMA’s latest recommendation above, the product registration holders of Esmya in several countries including the United Kingdom, France, Sweden, Israel and Hong Kong have decided to voluntarily recall the product.

Local situation

In line with EMA’s action, a temporary suspension on prescribing, dispensing, and ongoing treatment with Esmya (ulipristal acetate 5 mg) for uterine fibroids was effected in Malaysia on 17 March 2020. A Direct Healthcare Professional Communication (DHPC) has been distributed by Zuellig Pharma Sdn. Bhd. related to this safety issue and suspension.

Zuellig Pharma has issued a recall notification to all customers. Kindly contact Zuellig Pharma for any related enquiries.

NPRA will continue to review this safety issue and monitor the product recall. Any further risk minimisation measures will be duly informed.  

Advice to healthcare professionals 

• Stop prescribing Esmya for the treatment of uterine fibroids.
• Contact patients who are currently being treated with Esmya for uterine fibroids as soon as possible and advise them to stop their treatment and return any unconsumed or partially consumed stock of Esmya to their doctor or pharmacist. Consider other treatment options as appropriate.
• Advise patients to immediately report signs and symptoms of liver injury such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia and jaundice.
• Perform liver function test at 2–4 weeks after stopping treatment.

Advice to patients

If you are taking Esmya for the treatment of uterine fibroids, stop taking this medicine immediately.

• Return any unconsumed or partially consumed stock of Esmya to your doctor or pharmacist as soon as possible.
• Seek immediate medical attention if you develop symptoms of liver injury such as tiredness, loss of appetite, abdominal pain, yellowing of the skin, darkening of the urine, nausea and vomiting.
• Consult your doctor or pharmacist if you have any questions or concerns about your treatment.

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.