Paul-Ehrlich-Institut

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Bulletin on Drug Safety - Current Issue 1/2020 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 on current aspects of the risk assessment of drugs from both federal institutes. 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 language.

Topics of the Current Issue

  • Editorial: Transparency creates trust and knowledge – evaluation of suspected adverse reactions to vaccines
  • Dealing with drug risks exemplified by nitrosamines
  • Therapy with NSAID and paracetamol in pregnancy
  • Pharmacovigilance data on vaccines from 2018
  • Safety profile of rubella vaccines for (inadvertent) vaccination during pregnancy
  • Reports from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – January to March 2020
  • Revision of the product information wording - extracts from the PRAC recommendations on signals
  • References to 'Dear Doctor Letter' (Rote-Hand-Brief) and safety information

Further Information

Bulletin on Drug Safety, Issue 1/2020 (German only)
www.pei.de/bulletin-safety

Updated: 30.03.2020