EMA Issues Drug Warnings and Review

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During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.

On Dec. 1, 2017, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) announced findings from its November 2017 meeting. In the meeting, PRAC announced warnings about Xofigo, recommended suspension of drugs containing modified-release paracetamol, and started a review of Esmya.

A review of Esmya (ulipristal acetate), which is used to treat uterine fibroids, follows reports of serious liver injury after use of the drug. Three of these reports resulted in liver transplants. PRAC plans on evaluating all available data to determine the implications of use of this treatment.

The committee issued a warning about the use of Xofigo, which is used to treat prostate cancer, in combination with Zytiga and prednisone or prednisolone. The warning comes after reports on increased risk of death and fractures that came from an ongoing clinical trial with Xofigo, which “is comparing Xofigo with placebo, both given in combination with Zytiga (abiraterone acetate) and prednisone or prednisolone. It includes prostate cancer patients with no symptoms or only mild symptoms, such as pain,” according to EMA. PRAC will review the results of the clinical trial and other data when available.


During the meeting, PRAC also confirmed its recommendation to suspend marketing of modified- or prolonged-release paracetamol containing medicines. These drugs are designed to release paracetamol slowly over a longer period than the usual immediate-release medicines. The recommendation comes after the committee reexamined a previous recommendation made in September 2017.

Source: EMA