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Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database

Mulugeta Russom1, Yodit Fitsum2, Abiel Abraham3

  • 1Eritrean Pharmacovigilance Centre, National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea. satiswt@gmail.com.

Drugs - Real World Outcomes
|March 31, 2021
PubMed
Abstract

Insights

Diclofenac may cause rhabdomyolysis, a serious muscle condition, despite not being officially documented. This study found a probable causal link, highlighting the need for awareness among healthcare providers and patients.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Clinical Toxicology

Background:

  • Diclofenac, a common nonsteroidal anti-inflammatory drug (NSAID), lacks documented rhabdomyolysis in official drug safety summaries.
  • However, eight published case reports suggest a potential association between diclofenac use and rhabdomyolysis.

Purpose of the Study:

  • To investigate the evidence for a causal relationship between diclofenac and rhabdomyolysis.
  • To analyze case reports and safety database information to assess this association.

Main Methods:

  • A descriptive analysis of rhabdomyolysis cases associated with diclofenac was performed.
  • Data was extracted from the WHO Global Database of Individual Case Safety Reports (VigiBase) and published literature.

Main Results:

  • 70 eligible cases were identified in VigiBase, with a median age of 56.5 years.
  • Rhabdomyolysis onset occurred at a median of 3 days post-diclofenac administration in 26 reports.
  • In 30 cases, symptoms resolved after diclofenac withdrawal, with 7 cases meeting criteria for 'probable' causality. Diclofenac was also an indirect cause in 5 cases via injection-site necrosis. Eight fatalities occurred, with intramuscular administration being over-represented.

Conclusions:

  • Available data indicates a probable causal link between diclofenac and rhabdomyolysis, either directly or indirectly.
  • The findings suggest that diclofenac's potential to cause rhabdomyolysis warrants further clinical attention and safety monitoring.

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