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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
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
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
Braitmaier M, Kollhorst B, Heinig M, Langner I, Czwikla J, Heinze F, Buschmann L, Minnerup H, Garcia-Albeniz X, Hense HW, Karch A, Zeeb H, Haug U, Didelez V. Effectiveness of mammography screening on breast cancer mortality - a study protocol for emulation of target trials using German health claims data. Clin Epidemiol. 2022 Nov 2;14:1293-303. doi: 10.2147/CLEP.S376107
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
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
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
Arana A, Pottegard A, Kuiper J, Booth H, Reutfors J, Calingaert B, Lund LC, Crellin E, Schmitt-Egenolf M, Kaye J, Gembert K, Rothman K, Kieler H, Dedman D, Houben E, Gutierrez L, Hallas J, Perez-Gutthann S. Long-term risk of skin cancer and lymphoma in users of topical tacrolimus and pimecrolimus: final results from the extension of the cohort study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE). Clin Epidemiol. 2021 Dec 29;2021(13):1141-53. doi: 10.2147/CLEP.S331287
Ersbøll AK, Sengupta K, Pukkala E, Bolin K, Aas E, Emneus M, Ramey DR, Brady JE, Mines D, Aasbjerg K, Vestergaard C, Gislason G, Born AP, Kjærulff TM. Desloratadine exposure and incidence of seizure: a nordic post-authorization safety study using a new-user cohort study design, 2001-2015. Drug Saf. 2021 Nov;44(11):1231-42. doi: 10.1007/s40264-021-01106-7
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
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
Anthony MS, Armstrong MA, Getahun D, Scholes D, Gatz J, Schulze-Rath R, Postlethwaite D, Merchant M, Alabaster AL, Chillemi G, Raine-Bennett T, Xie F, Chiu VY, Im TM, Takhar HS, Fassett M, Grafton J, Cronkite D, Ichikawa L, Reed SD, Hui SL, Ritchey ME, Saltus CW, Andrews EB, Rothman KJ, Asiimwe A, Lynen R, Schoendorf J. Identification and validation of uterine perforation, intrauterine device expulsion, and breastfeeding in four health care systems with electronic health records. Clin Epidemiol. 2019 Jul 23;2019(11):635-43. doi: 10.2147/CLEP.S201044
Castellsague J, Kuiper JG, Pottegard A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundstrom A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation – JOELLE study). Clin Epidemiol. 2018 Mar 13;2018(10):299-310. doi: 10.2147/CLEP.S146442
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.
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.