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Drug safety study Publications

Drug safety study Publications

  • Antipsychotic drug use associated with urinary tract infections in older women.Abstract

    OBJECTIVES: Antipsychotic drugs are frequently prescribed to elderly patients, but they are associated with serious adverse effects. The objective of the current study was to investigate the association between use of antipsychotics by elderly womeand the risk of urinary tract infections (UTIs). COHORT STUDY SETTING: Dispensing data were obtained from the PHARMO Database Network for the period 1998-2008

    van Strien AM, Souverein PC, Keijsers CK, Heerdink ER, Derijks HJ, van Marum RJ. Maturitas. 2017 Apr; 98 46-50.
  • Post authorization safety study comparing quetiapine to risperidone and olanzapine.Abstract

    OBJECTIVES: To compare rates of specific adverse outcomes between patients starting quetiapine, olanzapine, or risperidone use in the Netherlands. METHODS: Observational study using the PHARMO Database Network, including patients starting quetiapin(4658), olanzapine (5856), or risperidone (7229) in 2000-2009, comparing rates of all-cause mortality, failed suicide attempts, extrapyrimidal symptoms (EPS), diabetes mellitus (DM), hypothyroidism, and acute myocardial infarction (AMI)

    Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Hum Psychopharmacol. 2016 Jul; 31 304-12.
  • Prescription behavior for gastroprotective drugs in new users as a result of communications regarding clopidogrel-proton pump inhibitor interaction.Abstract

    Safety concerns of the concomitant use of clopidogrel-proton pump inhibitors (PPIs) were published in 2009 and 2010 by the medicines regulatory agencies, including a direct healthcare professional communication. We examined the association between various safety statements and prescription behavior for gastroprotective drugs in naive patients in the Netherlands during the years 2008-2011

    Pharmacology Research & Perspectives. July 18; 4 e00242.
  • Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study.Abstract

    Analyses of healthcare data from 30 million individuals in three countries showed that current use of bisphosphonates may be associated with a small increased risk of cardiac valvulopathy (vs. those not exposed within the previous year), although cnfounding cannot be entirely ruled out. The observed tendency for decreased valvulopathy risk with cumulative duration of bisphosphonate use >6 months may even indicate a protective effect with prolonged use

    Coloma PM, deRidder M, Bezemer I, Herings RM, Gini R, Pecchioli S, Scotti L, Rijnbeek P, Mosseveld M, van der Lei J, Trifiro G, Sturkenboom M, Consortium Eu-Adr. Osteoporos Int. 2016 May; 27 1857-67.
  • Oral and inhaled corticosteroid use and risk of recurrent pulmonary embolism.Abstract

    INTRODUCTION: Chronic inflammatory diseases predispose for development of a first pulmonary embolism (PE). Previous studies showed that corticosteroids, which are the mainstay of treatment for inflammatory diseases, enhance the risk of a first venos thromboembolism. Yet, it is unknown whether corticosteroids also predispose for recurrent events

    Sneeboer MM, Hutten BA, Majoor CJ, Bel EH, Kamphuisen PW. Thromb Res. 2016 Feb 12; 140 46-50.
  • Pioglitazone use and risk of bladder cancer in patients with type 2 diabetes: retrospective cohort study using datasets from four European countries.Abstract

    OBJECTIVE: To evaluate the association between pioglitazone use and bladder cancer risk in patients with type 2 diabetes. DESIGN: Retrospective cohort study using propensity score matched cohorts. SETTINGS: Healthcare databases from Finland, the Neherlands, Sweden, and the United Kingdom. Data comprised country specific datasets of linked records on prescriptions, hospitals, general practitioners, cancer, and deaths

    Korhonen P, Heintjes EM, Williams R, Hoti F, Christopher S, Majak M, Kool-Houweling L, Strongman H, Linder M, Dolin P, Bahmanyar S. BMJ. 2016 354 i3903.
  • Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study.Abstract

    OBJECTIVES: To investigate the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs) and estimate the risk of hospital admission for heart failure with use of individual NSAIDs. DESIGN: Nested case-control study. SETTING: Five poplation based healthcare databases from four European countries (the Netherlands, Italy, Germany, and the United Kingdom)

    Arfe A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff V, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom M, Corrao G, SafetyofNon-steroidalAnti-inflammatoryDrugsProject Consortium. BMJ. 2016 354 i4857.
  • Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.Abstract

    BACKGROUND AND OBJECTIVE: Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detecion, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection

    Pacurariu AC, Straus SM, Trifiro G, Schuemie MJ, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Peder sen L, Arlett P, van der Lei J, Sturkenboom MC, Coloma PM. Drug Saf. 2015 Dec; 38 1201-10.
  • The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.Abstract

    AIM: Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In tis paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years)

    deBie S, Coloma PM, Ferrajolo C, Verhamme KM, Trifiro G, Schuemie MJ, Straus SM, Gini R, Herings R, Mazzaglia G, Picelli G, Ghirardi A, Peder sen L, Stricker BH, van der Lei J, Sturkenboom MC, consortium Eu-Adr. Br J Clin Pharmacol. 2015 Aug; 80 304-14.
  • Quick assessment of drug-related admissions over time (QUADRAT study).Abstract

    PURPOSE: To develop a computerized prescreening procedure for the identification of possible/probably Hospital Admissions potential Related to Medications (HARMs). METHOD: Pairs of drugs and reasons for hospitalization (generated automatically fromthe PHARMO record linkage database by using two data mining techniques) were assessed manually to determine whether they represented pharmacologically plausible adverse drug events (PP-ADEs)

    Warle-van Herwaarden MF, Valkhoff VE, Herings RM, Engelkes M, van Blijder veen JC, Roden burg EM, deBie S, Alsma J, van deSteeg-Gompel C, Kramers C, Meyboom RH, Sturkenboom MC, DeSmet PA. Pharmacoepidemiol Drug Saf. 2015 May; 24 495-503.