{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T18:12:38Z","timestamp":1789150358756,"version":"build-2803163510"},"reference-count":48,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,1,9]],"date-time":"2021-01-09T00:00:00Z","timestamp":1610150400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Retroperitoneal fibrosis (RPF) is a rare chronic fibro\u2010inflammatory disorder that may be secondary to certain drugs, including \u03b2\u2010blocking agents (BBAs). However, their causative role is unclear. We aimed to investigate this association.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Disproportionality analysis was carried out on cases from 1985 to 4 October 2020 in VigiBase, the World Health Organization pharmacovigilance database. The Bayesian\u2010based IC<jats:sub>025<\/jats:sub> metric and reporting odds ratio were used in order to assess the adverse event signal. We also analysed all published case reports from the literature regarding BBA\u2010associated RPF to assess the value of suggested supportive clinical evidence.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 1599 individual case safety reports of RPF were reported to VigiBase, of which 132 (32%) concerned 16 different single BBA. For 12 of these agents (75%), reporting of RPF was disproportionate, indicating a potential safety signal. Line listing analysis of individual case safety reports showed no consistent time interval from start of BBA to RPF diagnosis (range 0.7\u2013264 mo). Dechallenge was negative or unknown in the majority of cases (74%). In 18 published cases from the literature, time from start of BBA to RPF diagnosis varied widely (range 3\u2013156 mo). BBA were discontinued 6\u00a0months before (<jats:italic>n\u00a0=<\/jats:italic>\u00a01) or at the time of RPF diagnosis (<jats:italic>n\u00a0=<\/jats:italic>\u00a017). Most patients (84%) also received RPF specific treatment. Follow\u2010up duration was short (median 5 mo [range 1\u201324 mo]) and in most cases (83%) relevant follow\u2010up data were lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Although disproportionality analysis indicated a potential safety signal for RPF associated with BBAs, clinical evidence did not support a cause\u2010and\u2010effect relationship.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14702","type":"journal-article","created":{"date-parts":[[2020,12,17]],"date-time":"2020-12-17T01:08:25Z","timestamp":1608167305000},"page":"2891-2901","source":"Crossref","is-referenced-by-count":4,"title":["Retroperitoneal fibrosis and \u03b2\u2010blocking agents: Is there an association?"],"prefix":"10.1111","volume":"87","author":[{"given":"Hardjit","family":"Kharagjitsing","sequence":"first","affiliation":[{"name":"Department of Internal medicine, Dutch national center of expertise for retroperitoneal fibrosis Albert Schweitzer hospital  Dordrecht The Netherlands"},{"name":"Department of Clinical Pharmacy &amp; Toxicology Leiden University Medical Center  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rike","family":"van Eekeren","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"},{"name":"Department of Pharmacotherapy, epidemiology and economics, Groningen Research Institute of Pharmacy University of Groningen  The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eug\u00e8ne P.","family":"van Puijenbroek","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"},{"name":"Department of Pharmacotherapy, epidemiology and economics, Groningen Research Institute of Pharmacy University of Groningen  The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teun","family":"van Gelder","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy &amp; Toxicology Leiden University Medical Center  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9803-1715","authenticated-orcid":false,"given":"Eric F. 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