FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA’s Pharmacovigilance Committee Recommends Label Changes

June 5, 2017
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A European Medicines Agency pharmacovigilance panel has issued new labeling recommendations to sponsors of certain approved drug products.

The agency’s Pharmacovigilance Risk Assessment Committee recommended changing marketing authorizations for several insulin medications, to include wording on potential errors associated with pre-filled pens and cartridges that could lead to inadequate diabetes control.

The panel said drugmakers Sanofi-Aventis and Novo Nordisk should submit updates to package leaflets to align them with the EMA’s risk minimization strategy for high-strength and fixed-combination insulin products, related to the misuse of pens using a syringe. The named products include Sanofi’s Insuman and Toujeo, and Novo Nordisk’s Tresiba, Ryzodeg and Xultophy.

In addition, for separate products containing brentuximab vedotin — also known as Adcetris, an antibody-drug conjugate for the treatment of Hodgkin lymphoma — the PRAC recommended adding warnings of new or reactivated cytomegalovirus infections, following a review of EudraVigliance safety monitoring data and clinical trial results. Adcetris, sponsored by Takeda in the EU, was granted conditional approval in October 2012.

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