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Drug safety study Publications

Drug safety study Publications

  • Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection.Abstract

    Background Electronic reporting and processing of suspected adverse drug reactions (ADRs) is increasing and has facilitated automated screening procedures. It is crucial for healthcare professionals to understand the nature and proper use of data aailable in pharmacovigilance practice. Objectives To (a) compare performance of EU-ADR [electronic healthcare record (EHR) exemplar] and FAERS [spontaneous reporting system (SRS) exemplar] databases in detecting signals using “positive” and “negative” drug-event reference sets; and (b) evaluate the impact of timing bias on sensitivity thresholds by comparing all data to data restricted to the time before a warning/regulatory action

    Patadia VK, Schuemie MJ, Coloma P, Herings R, van der Lei J, Straus S, Sturkenboom M, Trifiro G. Int J Clin Pharm. 2015 Feb; 37 (1): 94-104.
  • Using real-world healthcare data for pharmacovigilance signal detection – the experience of the EU-ADR project.Abstract

    A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA’s Adverse Event Reporting System and WHO’s Vigibase is reported. The study compard drug safety signals found in the EU-ADR and SRS databases

    Patadia VK, Coloma P, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Fornari C, Peder sen L, van der Lei J, Sturkenboom M, Trifiro G, consortium Eu-Adr. Expert Rev Clin Pharmacol. 2015 Jan; 8 (1): 95-102.
  • Risk of upper gastrointestinal bleeding from different drug combinations.Abstract

    BACKGROUND & AIMS: Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin increases the risk of upper gastrointestinal bleeding (UGIB). Guidelines suggest avoiding certain drug combinations, yet little is known abouthe magnitude of their interactions. We estimated the risk of UGIB during concomitant use of nonselective (ns)NSAIDs, cyclooxygenase -2 selective inhibitors (COX-2 inhibitors), and low-dose aspirin with other drugs

    Masclee GM, Valkhoff VE, Coloma PM, deRidder M, Romio S, Schuemie MJ, Herings R, Gini R, Mazzaglia G, Picelli G, Scotti L, Peder sen L, Kuipers EJ, van der Lei J, Sturkenboom MC. Gastroenterology. 2014 Oct; 147 (4): 784-792 e9.
  • Association between ADHD drug use and injuries among children and adolescents.Abstract

    To study the association between attention deficit hyperactivity disorder (ADHD) drug use and the incidence of hospitalization due to injuries. A random sample of 150,000 persons (0-18 years) was obtained from the Dutch PHARMO record linkage systemAn ADHD medication cohort as well as an up to six age/sex/index date sampled control cohort with no history of ADHD drug use was formed

    van den Ban E, Souverein P, Meijer W, van Engeland H, Swaab H, Egberts T, Heerdink E. Eur Child Adolesc Psychiatry. 2014 Feb; 23 (2): 95-102.
  • Signal detection of potentially drug-induced acute liver injury in children using a multi-country healthcare database network.Abstract

    BACKGROUND: Data mining in spontaneous reporting databases has shown that drug-induced liver injury is infrequently reported in children. OBJECTIVES: Our objectives were to (i) identify drugs potentially associated with acute liver injury (ALI) inhildren and adolescents using electronic healthcare record (EHR) data; and (ii) to evaluate the significance and novelty of these associations

    Ferrajolo C, Coloma PM, Verhamme KM, Schuemie MJ, deBie S, Gini R, Herings R, Mazzaglia G, Picelli G, Giaquinto C, Scotti L, Avillach P, Peder sen L, Rossi F, Capuano A, van der Lei J, Trifiro G, Sturkenboom MC, consortium Eu-Adr. Drug Saf. 2014 Feb; 37 (2): 99-108.
  • The effects of Psychotropic drugs On Developing brain (ePOD) study: methods and design.Abstract

    BACKGROUND: Animal studies have shown that methylphenidate (MPH) and fluoxetine (FLX) have different effects on dopaminergic and serotonergic system in the developing brain compared to the developed brain. The effects of Psychotropic drugs On the Dveloping brain (ePOD) study is a combination of different approaches to determine whether there are related findings in humans

    Bottelier MA, Schouw ML, Klomp A, Tamminga HG, Schrantee AG, Bouziane C, de Ruiter MB, Boer F, Ruhe HG, Denys D, Rijsman R, Lindauer RJ, Reitsma HB, Geurts HM, Reneman L. BMC Psychiatry. 2014 14 48.
  • Isotretinoin exposure during pregnancy: a population-based study in The Netherlands.Abstract

    OBJECTIVE: To estimate isotretinoin exposure in Dutch pregnant women despite the implemented pregnancy prevention programme (PPP) and second, to analyse the occurrence of adverse fetal or neonatal outcomes in these isotretinoin exposed pregnancies.DESIGN: Population-based study. SETTING: The Netherlands

    Zomerdijk IM, Ruiter R, Houweling LM, Herings RM, Sturkenboom MC, Straus SM, Stricker BH. BMJ Open. 2014 4 (11): e005602.
  • Ineffectiveness and adverse events of nitrofurantoin in women with urinary tract infection and renal impairment in primary care.Abstract

    PURPOSE: To determine whether treatment with nitrofurantoin in women with urinary tract infection (UTI) and renal impairment in primary care is associated with a higher risk of ineffectiveness and/or serious adverse events than in women without renl impairment. METHODS: A cohort of 21,317 women treated with nitrofurantoin and a cohort of 7,926 women treated with trimethoprim, identified from the Pharmo Record Linkage System, were analysed

    Geerts AF, Eppenga WL, Heerdink R, Derijks HJ, Wensing MJ, Egberts TC, DeSmet PA. Eur J Clin Pharmacol. 2013 Sep; 69 (9): 1701-7.
  • Exposure to phototoxic NSAIDs and quinolones is associated with an increased risk of melanoma.Abstract

    PURPOSE: Ultraviolet radiation exposure is the most important exogenous risk factor for cutaneous malignancies. It is possible that phototoxic drugs promote the development of cutaneous melanoma (CM) by intensifying the effect of ultraviolet lightn the skin. We investigated the association between the use of common systemic phototoxic drugs and development of CM

    Siiskonen SJ, Koomen ER, Visser LE, Herings RM, Guchelaar HJ, Stricker BH, Nijsten TE. Eur J Clin Pharmacol. 2013 Jul; 69 (7): 1437-44.
  • Use of oral glucocorticoids and the risk of pulmonary embolism: a population-based case-control study.Abstract

    BACKGROUND: Recently, endogenous glucocorticoid excess has been identified as a risk factor for VTE. Whether exogenous use of glucocorticoids is associated with an increased risk of VTE is unclear. We aimed to quantify the risk of symptomatic pulmoary embolism (PE) in patients using corticosteroids. METHODS: A case-control study using the PHARMO Record Linkage System, a Dutch population-based pharmacy registry, was conducted

    Stuijver DJ, Majoor CJ, van Zaane B, Souverein PC, de Boer A, Dekkers OM, Buller HR, Gerde s VE. Chest. 2013 May; 143 (5): 1337-42.