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01.11.2019 | Products

Allergan Statement Regarding FIBRISTAL® Safety Review

Patient safety is Allergan’s highest priority.  We monitor and report any adverse reactions associated with our products.  Allergan has been working closely with Health Canada to complete a safety review of FIBRISTAL® (ulipristal acetate), approved to treat moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age.  The safety review found potential risk of liver injury associated with FIBRISTAL® use.  During post-market experience, rare cases of liver injury, including four international and isolated cases of serious liver impairment requiring liver transplantation, were reported.

Effective Use of FIBRISTAL®  - To support the safe use of this medication, Allergan has updated the Canadian product safety information for FIBRISTAL®.  The updates include new restrictions for use.  Before starting FIBRISTAL® treatment, liver function tests (LFTs) should be performed.  FIBRISTAL® should not be used in women who currently have or have previously had liver problems.  Intermittent use should be restricted to women of childbearing age who are not eligible for surgery to remove their fibroids.  In addition, the product safety information has been updated to include requirements for liver function monitoring before, during and after treatment. 

Women Continue to Benefit from FIBRISTAL® Around the Globe - In clinical studies, FIBRISTAL® has shown to provide efficacious bleeding control and a significant reduction of fibroid volume over repeated treatment courses, an increase of hemoglobin levels (anemia correction), and a significant increase in health-related quality of life returning patients to the level of healthy subjects.   As with any prescribed medication, patients should discuss their treatment options thoroughly with their physicians before starting treatment.

Allergan will continue to work closely with Health Canada to monitor and report any adverse reactions associated with FIBRISTAL® use in Canada.  For more information, please see the FIBRISTAL Product monograph on Allergan Canada’s Website: https://www.allergan.ca/en-ca/products/prescription.