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09.16.2020 | Other

Allergan Statement Regarding PRAC Ulipristal Acetate Recommendation

On Friday, September 4, 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) – which includes representatives from various European Union (EU) countries, responsible for pharmacovigilance safety on behalf of EU citizens – recommended the license for ESMYA® (ulipristal acetate, 5 mg) and all subsequent generics be revoked.  This decision is based upon a rare but serious risk of liver injury.  The PRAC recommendation has been submitted to the Committee for Medicinal Products for Human Use (CHMP) for ratification.  A final EU decision is expected on or after Thursday, September 17, 2020. 

ESMYA® (ulipristal acetate, 5 mg) is marketed as FIBRISTAL® (ulipristal acetate, 5 mg) in Canada by Allergan Canada, an AbbVie Company.  FIBRISTAL® (ulipristal acetate, 5mg), is approved by Health Canada for the treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age. 

We are monitoring this situation very closely and are in direct contact with Health Canada.

Nothing is more important than the health and safety of our patients.  We take every adverse event associated with our products seriously.