IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v40y2017i10d10.1007_s40264-017-0564-8.html
   My bibliography  Save this article

Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A Disproportionality Analysis Using the Italian National Network of Pharmacovigilance Database

Author

Listed:
  • Alice Capogrosso Sansone

    (University of Pisa)

  • Irma Convertino

    (University of Pisa)

  • Maria Teresa Galiulo

    (University of Pisa)

  • Stefano Salvadori

    (National Research Council)

  • Stefania Pieroni

    (National Research Council)

  • Tamara Knezevic

    (National Research Council)

  • Stefania Mantarro

    (University of Pisa)

  • Alessandra Marino

    (University of Pisa)

  • Manfred Hauben

    (Pfizer Inc.
    New York University School of Medicine)

  • Corrado Blandizzi

    (University of Pisa
    University Hospital of Pisa)

  • Marco Tuccori

    (University Hospital of Pisa)

Abstract

Introduction Proton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports. Aim This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database. Methods A disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016. Reporting odds ratio (ROR) and 95% confidence intervals (CIs) were calculated as a measure of disproportionality. In a secondary and tertiary analysis, we explored the association of PPIs with muscular ADRs after taking into account the masking effect of statins. Moreover, the possibility of an interaction between PPIs and statins, leading to the occurrence of muscular ADRs, was also tested. Results The study was carried out on 274,108 reports. The ROR of muscular ADRs for PPIs, adjusted for age and gender, was 1.484 (95% CI 1.204–1.829; p

Suggested Citation

  • Alice Capogrosso Sansone & Irma Convertino & Maria Teresa Galiulo & Stefano Salvadori & Stefania Pieroni & Tamara Knezevic & Stefania Mantarro & Alessandra Marino & Manfred Hauben & Corrado Blandizzi , 2017. "Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A Disproportionality Analysis Using the Italian National Network of Pharmacovigilance Database," Drug Safety, Springer, vol. 40(10), pages 895-909, October.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:10:d:10.1007_s40264-017-0564-8
    DOI: 10.1007/s40264-017-0564-8
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-017-0564-8
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40264-017-0564-8?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:40:y:2017:i:10:d:10.1007_s40264-017-0564-8. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.