Publications
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Rao S, McQuay LJ, Forns J, MacKay R, Danysh HE, Doshi D, Abler V, Anthony MS, Layton JB. Evaluation of mortality in users of pimavanserin compared with other atypical antipsychotics in patients with Parkinson's disease psychosis: an update. Drug Saf. 2025 Apr 9. doi: 10.1007/s40264-025-01543-8
Abtahi S, Pajouheshnia R, Duran CE, Riera-Arnau J, Gamba M, Alsina E, Hoxhaj V, Andersen M, Bartolini C, Kristiansen SB, Brown J, Hallgreen CE, Garcia-Poza P, Gardarsdottir H, Gini R, Girardi A, Holthuis E, Huerta C, Ibanez L, Limoncella G, Martin-Perez M, Paoletti O, Roberto G, Souverein P, Swart KMA, Wing K, Sturkenboom M, Klungel O. Impact of 2018 EU Risk minimisation measures and revised pregnancy prevention programme on utilisation and prescribing trends of medicinal products containing valproate: an interrupted time series study. Drug Saf. 2023 Jul;46(7):689-702. doi: 10.1007/s40264-023-01314-3
Chomistek AK, Phiri K, Doherty MC, Calderbank JF, Chiuve SE, McIlroy BH, Snabes MC, Enger C, Seeger JD. Correction to: development and validation of ICD‑10‑CM‑based algorithms for date of last menstrual period, pregnancy outcomes, and infant outcomes. Drug Saf. 2023 May;46(5):515. doi: 10.1007/s40264-023-01280-w
Chomistek AK, Phiri K, Doherty MC, Calderbank JF, Chiuve SE, McIlroy BH, Snabes MC, Enger C, Seeger JD. Correction to: development and validation of ICD‑10‑CM‑based algorithms for date of last menstrual period, pregnancy outcomes, and infant outcomes. Drug Saf. 2023 May;46(5):515. doi: 10.1007/s40264-023-01280-w
Johannes CB, Beachler DC, Layton JB, Danysh HE, Ziemiecki R, Arana A, Dinh J, Li L, Calingaert B, Pladevall-Vila M, Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A. Post-authorization safety study of hospitalization for acute kidney injury in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting. Drug Saf. 2023 Feb 1;46(2):157-74. doi: 10.1007/s40264-022-01263-3
Chomistek AK, Phiri K, Doherty MC, Calderbank JF, Chiuve SE, McIlroy BH, Snabes MC, Enger C, Seeger JD. Development and validation of ICD-10-CM-based algorithms for date of last menstrual period, pregnancy outcomes, and infant outcomes. Drug Saf. 2023 Feb;46(2):209-22. doi: 10.1007/s40264-022-01261-5
Danysh HE, Johannes CB, Beachler DC, Layton JB, Ziemiecki R, Arana A, Dinh J, Li L, Calingaert B, Pladevall-Vila M, Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A. Post-authorization safety studies of acute liver injury and severe complications of urinary tract infection in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting. Drug Saf. 2023 Feb 1;46(2):175-93. doi: 10.1007/s40264-022-01262-4
Layton JB, Forns Guzman J, McQuay LJ, Danysh HE, Dempsey C, Anthony MS, Turner ME. Mortality in patients with Parkinson's disease-related psychosis treated with pimavanserin compared with other atypical antipsychotics: a cohort study. Drug Saf. 2023 Feb 1;46(2):195-208. doi: 10.1007/s40264-022-01260-6
Abtahi S, Pajouheshnia R, Duran-Salinas C, Riera-Arnau J, Gamba M, Alsina E, Hallgreen CE, Limoncella G, Bartolini C, Martin-Perez M, Brown J, Sturkenboom M, Klungel O, Other Lot4 Consortium Members of the Valproate study1. Impact of the 2018 pregnancy prevention program on the use of oral retinoids in childbearing age females in Europe. Presented at the 21st International Society of Pharmacovigilance (ISoP) Annual Meeting 2022; September 20, 2022. Verona, Italy. [abstract] Drug Saf. 2022 Aug 29; 45:1111-327. doi: 10.1007/s40264-022-01219-7
Abtahi S, Pajouheshnia R, Duran-Salinas C, Riera-Arnau J, Gamba M, Alsina E, Hallgreen CE, Limoncella G, Bartolini C, Holthuis E, Martin-Perez M, Brown J, Sturkenboom M, Klungel O, Other Lot Consortium Members of the Valproate study. Impact of 2018 EU risk minimisation measures and revised pregnancy prevention programme on utilisation and prescribing trends of valproates. Poster presented at the 21st International Society of Pharmacovigilance (ISoP) Annual Meeting 2022; September 20, 2022. Verona, Italy. [abstract] Drug Saf. 2022 Aug 29; 45:1312-3. doi: 10.1007/s40264-022-01219-7
Beau-Lejdstrom R, Hong LS, Garcia de Albeniz X, Floricel F, Lorenzen J, Bonfitto F, Kalilani L, Loesch C, Luscombe G, Perez-Gutthann S, Mottet I, Foskett N. Incidence of acute renal failure in patients using Levetiracetam versus other antiseizure medications: a voluntary post-authorization safety study. Drug Saf. 2022 Jul;45(7):781-90. doi: 10.1007/s40264-022-01193-0
Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Phiri K, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD, mirabegron PMR-PASS study group. Cardiovascular risk in users of mirabegron compared with users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, multinational, cohort study. Drug Saf. 2021 Aug;44(8):899-915. doi: 10.1007/s40264-021-01095-7
Ruigomez A, Plana E, Gilsenan A, Fortuny J, Cainzos-Achirica M, Flynn RWV, MacDonald TM, Garcia-Rodriguez L, Ziemiecki R, Andrews EB. Identification and validation of major cardiovascular events in the United Kingdom data sources included in a multi-database post-authorization safety study of prucalopride. Drug Saf. 2021 May;44(5):541-51. doi: 10.1007/s40264-021-01044-4
Wen X, van der Laan M, Wyss R, Platt RW, Pajouheshnia R, Schneeweiss S. Machine learning to optimize and automate confounding control in studies using high-dimensional healthcare data. Presented at the Virtual 2020 36th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020. [abstract] Drug Saf. 2020 Oct 15; 29(S3):384. doi: 10.1002/pds.5114
Gilsenan A, Fortuny J, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Harding A, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu E, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: a multinational population-based cohort study. Drug Saf. 2019 Oct;42(10):1179-90. doi: 10.1007/s40264-019-00835-0
Fortuny J, Gilsenan A, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Study design and cohort comparability in a study of major cardiovascular events in new users of prucalopride versus polyethylene glycol 3350. Drug Saf. 2019 Oct;47(10):1167-77. doi: 10.1007/s40264-019-00836-z
Seeger JD, Bykov K, Bartels DB, Huybrechts K, Schneeweiss S. Propensity score weighting compared to matching in a study of dabigatran and warfarin. Drug Saf. 2017 Feb;40(2):169-81. doi: 10.1007/s40264-016-0480-3
Spoendlin J, Layton JB, Mundkur M, Meier C, Jick SS, Meier CR. The risk of Achilles or biceps tendon rupture in new statin users: a propensity score matched sequential cohort study. Drug Saf. 2016 Dec;39(12):1229-37.
Arana A, Johannes CB, McQuay LJ, Varas-Lorenzo C, Fife D, Rothman KJ. Risk of out-of-hospital sudden cardiac death in users of domperidone, proton pump inhibitors, or metoclopramide: a population-based nested case-control study. Drug Saf. 2015 Dec;38(12):1187-99. doi: 10.1007/s40264-015-0338-0.
Gagne JJ, Polinski JM, Rassen JA, Fischer MA, Seeger JD, Franklin JM, Liu J, Schneeweiss S, Choudhry NK. Selective serotonin reuptake inhibitor use and perioperative bleeding and mortality in patients undergoing coronary artery bypass grafting. Drug Saf. 2015 Nov;38(11):1075-82. doi: 10.1007/s40264-015-0328-2
Kesselheim AS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Seeger JD, Brownstein JS, Woloshin S, Schwartz LM, Toomey T, Dal Pan GJ, Avorn J. Methodological approaches to evaluate the impact of FDA drug safety communications. Drug Saf. 2015 Jun;38(6):565-75. doi: 10.1007/s40264-015-0291-y
Haleem MS, Han L, van Hemert J, Li B, Fleming A. Superpixel based retinal area detection in SLO images. Poster presented at the ICCVG 2014 International Conference; September 15, 2014. Warsaw, Poland. [abstract] Computer vision and graphics. 2014; 8671:254-61. doi: 10.1007/978-3-319-11331-9_31
Reichenpfader U, Gartlehner G, Morgan LC, Greenblatt A, Nussbaumer B, Hansen RA, Van Noord M, Lux L, Gaynes BN. Sexual dysfunction associated with second-generation antidepressants in patients with major depressive disorder: results from a systematic review with network meta-analysis. Drug Saf. 2014 Jan;37(1):19-31. doi: 10.1007/s40264-013-0129-4
Gulmez SE, Larrey D, Pageaux GP, Lignot S, Lassalle R, Jove J, Gatta A, McCormick A, Metselaar HJ, Monteiro E, Thorburn D, Bernal W, Zouboulis-Vafiadis I, de Vries C, Perez-Gutthann S, Sturkenboom M, Benichou J, Montastruc JL, Horsmans Y, Salvo F, Hamoud F, Micon S, Droz-Perroteau C, Blin P, Moore N. Transplantation for acute liver failure in patients exposed to NSAIDs or Paracetamol (acetaminophen): the multinational case-population SALT study. Drug Saf. 2013 Feb 1;36(2):135-44.
Castellsague J, Riera-Guardia N, Calingaert B, Varas-Lorenzo C, Fourrier-Reglat A, Nicotra F, Sturkenboom M, Perez-Gutthann S. Individual NSAIDS and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012 Dec 1;35(12):1127-46.
Herring WL, Herrmann JW. The single-day surgery scheduling problem: sequential decision-making and threshold-based heuristics. OR spectrum: quantitative approaches in management. 2012 Apr 1;34(2):429-59.
Arana A, Allen S, Burkowitz J, Fantoni V, Ghatnekar O, Rico MT, Vanhaverbeke N, Wentworth CE, Brosa M, Arellano FM. Infliximab paediatric Crohn's disease educational plan: a European, cross-sectional, multicentre evaluation. Drug Saf. 2010 Jun;33(6):489-501.
Arana A, Wentworth CE, Arellano FM. Validity of the codes of suicidality in the THIN database. Drug Saf. 2010;19(12):1316-7.
Hartford CG, Petchel KS, Mickail H, Perez-Gutthann S, McHale M, Grana JM, Marquez P. Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines. Drug Saf. 2006 Aug 1;29(8):657-73. doi: 10.2165/00002018-200629080-00003
Castellsague J, Perez GS, Garcia Rodriguez LA. Recent epidemiological studies of the association between hormone replacement therapy and venous thromboembolism. A review. Drug Saf. 1998 Feb 1;18(2):117-23.