SOCG Clinical Expert Opinion in Response to European Medicines Agency Recommended Revocation of UPA

You may be aware that the European Medicines Agency (EMA) has recently recommended the revocation of the authorization of ulipristal acetate (Fibristal) for the treatment of uterine fibroids, because of an unpredictable risk of liver injury. This recommendation has gone to the EMA’s Human Medicines Committee for implementation.

Health Canada is conducting its own independent review. We have not seen the same severity of liver injury in Canada, to date. Health Canada does recognize that there is also an unpredictable risk of severe injury or death associated with surgical management of fibroids, and that this medication has been an important option for women. Because of this, Health Canada did reach out to experts at the SOGC for their clinical opinion, and a response was prepared by a panel drawn from our clinical leaders. Click HERE to read the response. 

We have not heard what the implications of this European decision will be for practice in Canada, but it is relevant information that you would want to include in the fully informed consent process with your patients.

This advice does not apply to the use of UPA for emergency contraception.

We will keep you informed of any further developments, or decisions taken by either Health Canada or the manufacturer.