Metamizole and risk of hepatotoxicity –comparative cohort study of incidence of hepatic events in patients treated with metamizole vs. patients treated with paracetamol in IMS Disease Analyzer Germany between January 2009 and December 2018 (Metamizole and hepatotoxicity)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31865
• EU PAS number:
  EUPAS31864
• Study ID:
  31865
• Official title and acronym:
  Metamizole and risk of hepatotoxicity –comparative cohort study of incidence of hepatic events in patients treated with metamizole vs. patients treated with paracetamol in IMS Disease Analyzer Germany between January 2009 and December 2018 (Metamizole and hepatotoxicity)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Metamizole is a medication with analgesic, antipyretic, spasmolytic, and weak anti-inflammatory effects, used for acute and chronic pain management, and in some countries, fever management. Cases of drug-induced liver injury (DILI) have been reported in association with metamizole treatment, however the evidence from epidemiological studies is very limited (one case-control only). This study aims to quantify the incidence of hepatic events in patients treated with metamizole compared to patients treated with paracetamol or NSAIDs (chosen as an active comparator).
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/06/2018

Actual: 01/06/2018

Study start date

Planned: 01/01/2019

Actual: 01/04/2019

Data analysis start date

Planned: 15/04/2019

Actual: 15/06/2019

Date of final study report

Planned: 01/01/2020

Actual: 01/01/2020

Sources of funding

EMA

Study protocol

Initial protocol

Study-protocol -IMS DE-Metamizole_DILI 4 september 2019

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable