UPDATED - SOGC Recommendations on Ulipristal Acetate
In post-marketing monitoring of ulipristal acetate (Fibristal [Esmya in Europe]), a small number of cases of hepatotoxicity have come to light. In four cases, this has resulted in liver failure and liver transplantation, and in one case, severe complications in surgery leading to fatality.
In response to this, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has undertaken a thorough review, results of which are anticipated within the next one to three months.
At this point in time, the PRAC has not determined if there is a causal relationship between ulipristal acetate and liver toxicity. There was no suggestion of liver harm in the earlier research trials, and there is no known mechanism for injury. In the meantime, the EMA has recommended some precautionary measures. The measures that they are recommending are temporary and precautionary until they have completed their assessment; the EMA consider that currently the benefit/risk to the use of this medication remains favourable. Health Canada is also reviewing the reports and will be providing guidance.
In Canada, there is an amendment to the product monograph to provide notification to patients and health care professionals of the possibility of liver damage - a rare, but serious, adverse reaction.
The SOGC suggests:
- The potential risk of liver injury should be discussed with patients on this medication.
- Liver function testing for patients on ulipristal acetate, where feasible, is a sensible precaution.
- The decision to initiate a new patient on therapy should follow an informed discussion between a patient and her provider.
The SOGC recognizes that ulipristal acetate has been an important non-surgical alternative for women suffering with fibroids, and that the surgical procedures that would otherwise be needed carry their own risks.
We are hopeful that putting measures in place to detect possible liver toxicity at an early stage will prevent the more serious risks. And we look forward to further guidance from Health Canada and the EMA.