FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

EMA Pharmacovigilance Panel Makes Moves on Cancer, MS Drugs

June 16, 2017

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee declared the chemotherapy drug docetaxel safe to use after it concluded that there is no evidence of changes in the known risk of intestinal inflammation after treatment.

“Neutropenic enterocolitis remains a rare side effect of docetaxel and will continue to be under routine monitoring and evaluated during periodic reviews of docetaxel medicines,” the panel said following the PRAC’s June meeting.

The review came after reports of five fatal cases of neutropenic enterocolitis in France between August 2016 and February 2017. The Institut Curie in Paris stopped using docetaxel as of Feb. 15, replacing it with another taxane agent, paclitaxel. Neutropenic enterocolitis can occur in up to 1 in 1,000 treated patients.

Separately, the PRAC also announced it began reviewing Biogen and AbbVie’s Zinbryta (daclizumab), a treatment for relapsing forms of multiple sclerosis. The review was launched after the death of a patient from fulminant liver failure who was treated with Zinbryta in an ongoing observational study, as well as four other cases of serious liver injury.

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