PEI-Bul­letin on Drug Safe­ty – Cur­rent Is­sue 4/2021 Pub­lished

The Bulletin on Drug Safety is a cooperation between the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI). The quarterly publication provides information from both federal institutes on current aspects of the assessment of drugs. It focuses on pharmacovigilance – the continuous monitoring and evaluation of drug safety before and after marketing authorisation. The Bulletin includes articles on individual drugs as well as background information for understanding pharmacovigilance and research in this area.

The publication is available in German only.

Topics of the Current Issue

  • Editorial: One year of vaccination against COVID-19
  • Sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors) and the incidence of diabetic ketoacidosis (DKA)
  • Prescription quality of oral fluoroquinolones in the federal states 2014 to 2019
  • Safety, immunogenicity and interchangeability of biosimilars – focus on monoclonal antibodies and fusion proteins
  • Further development and use of mass spectrometry-based screening methods for the detection of N-nitrosamines of toxicological concern in pharmaceuticals
  • Announcements from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – October to December 2021
  • Revision of the product information wording
  • References to ‘Dear Doctor Letters’ (Rote-Hand-Briefe) and safety information here

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