Canada’s health regulator announced it was restricting the use of Allergan‘s uterine fibroid treatment Esmya after discovering a risk of serious liver injury from the drug. Health Canada said in a Reuters Health report that the drug, sold under brand name Fibristal in the country, should not be used by women with liver problems, or those who have had such problems in the past.
It also said that more than one treatment course of the drug should be restricted to only those of childbearing age who are unable to undergo surgery to remove the fibroids.
The report says the US Food and Drug Administration in August, 2018 declined to approve the drug, requesting more information and citing safety issues outside the US. Regulators in Europe have also recommended restrictions on the use of the drug for some patients, to help minimise risks.
The report says the drug is sold in Europe by Hungarian drug-maker Richter. Richter has said it considered Esmya to be a safe and effective form of treatment.
Allergan and Richter were not immediately available for comment, the report says.Reuters Health report