(Reuters) – Allergan Plc said on Tuesday U.S. health regulators had declined to approve Esmya, its treatment for abnormal uterine bleeding in women with uterine fibroids, requesting more information and citing safety issues outside the United States.

The safety concerns raised could impact the company’s plan to sell its women’s health business.

Earlier this year, regulators in Europe slapped temporary restrictions on the use of the drug, after reports that it was linked to serious liver damage.

(Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)