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Drug-induced retroperitoneal fibrosis: a case/non-case study in the French PharmacoVigilance Database

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  • Additional Information
    • Contributors:
      Centre d'investigation clinique Biothérapie CHU Pitié-Salpêtrière (CIC-BTi); Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Hôpital Cochin AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Hospices Civils de Lyon (HCL); Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E)
    • Publication Information:
      CCSD
      Informa Healthcare
    • Publication Date:
      2020
    • Collection:
      Hospices Civils de Lyon (HCL): HAL
    • Abstract:
      International audience ; Objectives: The potential role of drugs in the onset of retroperitoneal fibrosis (RPF) is poorly understood. The aim of this study was to identify drugs that may cause RPF.Methods: The authors used case/non-case method in the French PharmacoVigilance Database (FPVD).Results: Among the 722992 reports recorded, 73 cases of RPF were identified. 67% were men and the median age was 60 years (range 26-87). In these 73 cases, 176 drugs were 'suspect.' Derivatives of ergot alkaloids (DEA) presented the most significant association with RPF. To a lesser extent, significant associations were found with many drugs used in cardiology, e.g. beta-blockers, platelet antiaggregant, statins, and antihypertensive drugs, drugs used in neuropsychiatry, e.g. hypnotics, antiepileptic drugs, anxiolytics, antipsychotics, and antidepressants, and with other pharmacological classes, e.g. TNF-alpha antagonists.Conclusion: This study confirmed an association between RPF and derivatives of ergot alkaloids. These data represent a pharmacovigilance signal despite the limits of non/non-case method (underreporting, confounding factors, etc.). Indeed, a significant signal was found with drugs less known (TNF-α antagonists) or not known (some hypnotics, antiepileptic drugs, antipsychotics, anxiolytics, and antidepressants) to induce such an adverse drug reaction (ADR). Finally, these data could contribute to realize prospective studies to confirm these signals.
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/32374194; PUBMED: 32374194
    • Accession Number:
      10.1080/14740338.2020.1766022
    • Online Access:
      https://hal.sorbonne-universite.fr/hal-02946433
      https://hal.sorbonne-universite.fr/hal-02946433v1/document
      https://hal.sorbonne-universite.fr/hal-02946433v1/file/drug.pdf
      https://doi.org/10.1080/14740338.2020.1766022
    • Rights:
      info:eu-repo/semantics/OpenAccess
    • Accession Number:
      edsbas.E64821E8