FDAnews Drug Daily Bulletin

EMA Issues New Safety Recommendations for Gilead’s Zydelig

March 25, 2016

Days after the European Medicines Agency launched an investigation into Gilead’s Zydelig, the agency’s Pharmacovigilance Risk Assessment Committee now is recommending the drug be taken with antibiotics to prevent pneumonia.

The PRAC recommends that patients are monitored by administering routine blood tests to reduce the risk of infection.

The committee also asks new patients who have not previously undergone chemotherapy to write the treatment off and advises those on the drug to not discontinue treatment before consulting with a doctor.