Health Canada announced that it is doing a safety review of Fibristal (ulipristal acetate), a once-daily pill used to treat uterine fibroids (benign growths) in women.
The safety review follows reports of serious adverse events affecting the liver that have occurred in some women, including rare instances of damage so severe that a liver transplant was required.
Due to the potential risk of serious liver injury, Health Canada has advised that until their review is completed, clinicians should consider the following:
- Before starting patients on Fibristal, evaluate and discuss with them the benefits and risks associated with the medication.
- Do not prescribe Fibristal treatment if your patient has active/concomitant hepatic disease.
- Monitor your patient’s liver function at least once a month during their Fibristal treatment and 2-4 weeks after completion of treatment.
- If your patient shows signs or symptoms compatible with liver injury (nausea, vomiting, fatigue, abdominal pain, jaundice), conduct liver function tests on them immediately.
- Advise your patients about the signs and symptoms of liver injury.
Fibristal has been available in Canada since 2013. Surprisingly, it is not available in the United States (US) yet but is under review by the US Food and Drug Administration (FDA). Recently, the FDA extended their review period for the drug with an expected decision made by August 2018. It is not known if the extension is due to new safety concerns or not.