Paul-Ehrlich-Institut

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Bul­letin on Drug Safe­ty - Cur­rent Is­sue 2/2021 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 on current aspects of the 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: safe use of combined hormonal contraceptives
  • Gadolinium-containing contrast agents: deposition in body and brain and potentially related long-term consequences - current status and outlook from a regulatory perspective
  • Risk of venous thromboembolism associated with the use of combined hormonal contraceptives
  • Adverse reactions during blood donation: results of an online survey among donors in Germany
  • Reports from BfArM and PEI
  • PRAC recommendations within the framework of EU referral procedures – April to June 2021
  • Revision of the product information wording
  • References to the ‘Dear Doctor Letter’ (Rote-Hand-Brief) and safety information

Further Information

Bulletin on Drug Safety, Issue 2/2021 (German only)
www.pei.de/bulletin-safety

Updated: 30.06.2021