Updated SOGC guidelines include FIBRISTAL as only approved medical treatment for uterine fibroids

Jun 4 2015

The Society for Obstetrics and Gynecology of Canada (SOGC) has issued updated guidelines for the management of uterine fibroids (uterine leiomyomas), which now include the first and only approved medical treatment for uterine fibroids: FIBRISTAL (ulipristal acetate).

FIBRISTAL was recommended, based on Level 1 evidence, for treatment of abnormal uterine bleeding associated with fibroids, bulk symptoms and anemia correction. The SOGC guidelines state that studies show "[ulipristal acetate] …effectively and safely controlled bleeding and shrunk fibroids in patients with symptomatic fibroids …of all the hormonal options available for women with fibroids, ulipristal acetate has the most rapid documented onset of action and control of bleeding."

"These new guidelines are the result of a comprehensive scientific evidence review, and reflect the most up-to-date best practices in the management of uterine fibroids," says Dr. George Vilos, the lead author of the SOGC Guidelines on the management of uterine fibroids and Professor of Obstetrics and Gynecology at Western University in London, Ontario. "The inclusion of FIBRISTAL is an acknowledgment of its importance in the management of this very common and challenging condition."

FIBRISTAL was approved in Canada in June 2013 for the treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery. It is the only Health Canada approved medical treatment for uterine fibroids. Currently, the only provincial drug program providing access to FIBRISTAL is in Quebec; women under public insurance in all other provinces do not have access to FIBRISTAL.

Until the availability of FIBRISTAL, treatments for uterine fibroids in Canada included off-label medication to reduce symptoms, or surgery to remove individual fibroids (myomectomy) or the woman's whole uterus (hysterectomy) if the condition became debilitating.