Bul­letin on Drug Safe­ty – Cur­rent Is­sue 4/2022 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 in the Current Issue

  • Editorial: Safety of COVID-19 vaccines
  • Contamination of herbal, homeopathic or anthroposophical drugs with pyrrolizidine alkaloids – regulatory requirements and measures by the pharmaceutical industry to minimize risk
  • Long-acting growth hormone analogues for the substitution of endogenous growth hormone in children and adults with growth hormone deficiency: once-weekly dosing
  • Metamizole: serious adverse events – update
  • Suspected adverse reactions or vaccination complications following vaccination with the Omicron-adapted bivalent COVID-19 vaccines Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4-5 and Spikevax bivalent/Omicron BA.1 (registered in Germany through 31 October 2022)
  • PRAC recommendations within the framework of EU referral procedures – October to December 2022
  • Revision of product information wording – excerpts from the PRAC recommendations on signals
  • References to ‘Dear Doctor Letters’ (Rote-Hand-Briefe) and safety information

Further Information

Bulletin on Drug Safety, Issue 4/2022 (German only)