Publications

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Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study

• Author

  Alison Evans Miranda Davies Vicki Osborne Debabrata Roy Saad Shakir

  Alison Evans, Miranda Davies, Vicki Osborne, Debabrata Roy, Saad Shakir

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  BMJ Open 2020;10:e038102. doi: 10.1136/bmjopen-2020-038102

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Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?

• Author

  Sandeep Dhanda Vicki Osborne Elizabeth Lynn Saad Shakir

  Sandeep Dhanda, Vicki Osborne, Elizabeth Lynn, Saad Shakir

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  BMJ Evidence-Based Medicine Published Online First: 21 October 2020. doi: 10.1136/bmjebm-2020-111507

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Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study

• Author

  Alison Evans Miranda Davies Vicki Osborne Debabrata Roy Saad Shakir

  Alison Evans, Miranda Davies, Vicki Osborne, Debabrata Roy, Saad Shakir

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  PLoS ONE October 2020 15(10): e0240489. https://doi.org/10.1371/journal.pone.0240489

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Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England

• Author

  Vicki Osborne Miranda Davies Alison Evans Saad A. W. Shakir

  Vicki Osborne, Miranda Davies, Alison Evans, Saad Shakir

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  Therapeutic Advances in Psychopharmacology. January 2020. https://doi.org/10.1177/2045125320954616

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Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment

• Author

  Vicki Osborne Miranda Davies Samantha Lane Alison Evans Jacqueline Denyer Sandeep Dhanda Debabrata Roy Saad Shakir

  Vicki Osborne, Miranda Davies, Samantha Lane, Alison Evans, Jacqueline Denyer, Sandeep Dhanda, Debabrata Roy, Saad Shakir

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  Drug Safety. 2020. https://doi.org/10.1007/s40264-020-00966-9

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Remdesivir in Treatment of COVID‑19: A Systematic Benefit–Risk Assessment

• Author

  Miranda Davies Vicki Osborne Samantha Lane Debabrata Roy Sandeep Dhanda Alison Evans Saad Shakir

  Miranda Davies, Vicki Osborne, Samantha Lane, Debabrata Roy, Sandeep Dhanda, Alison Evans, Saad Shakir

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  Drug Safety. 2020. https://doi.org/10.1007/s40264-020-00952-1

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The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK

• Author

  Kevin Klein Lorna Hazell Pieter Stolk Saad Shakir

  Kevin Klein, Lorna Hazell, Pieter Stolk, Saad Shakir

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  Drug Safety. 2020 March, 43, 255–263 https://doi.org/10.1007/s40264-019-00891-6

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Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice

• Author

  Luis Alberto García-Rodríguez  Mari-Ann Wallander Leif Friberg Ana Ruigomez Tania Schink Irene Bezemer Ron Herings Saad Shakir Alison Evans Miranda Davies Kiliana Suzart-Woischnik Pareen Vora Yanina Balabanova Montse Soriano-Gabarró Gunnar Brobert

  Luis Alberto García-Rodríguez , Mari-Ann Wallander, Leif Friberg, , Tania Schink, Irene Bezemer, Ron Herings, Saad Shakir, Alison Evans, Miranda Davies, Kiliana Suzart-Woischnik, Pareen Vora, Yanina Balabanova, Montse Soriano-Gabarró, Gunnar Brobert

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  Expert Opinion on Drug Safety 2020, DOI: 10.1080/14740338.2020.1798928

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Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management

• Author

  Vicki Osborne Miranda Davies Debabrata Roy Francesco Tescione  Saad A W Shakir

  Vicki Osborne, Miranda Davies, Debabrata Roy, Francesco Tescione , Saad Shakir

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  BMJ Evidence-Based Medicine Published Online First: 24 February 2020. doi: 10.1136/bmjebm-2019-111295

First Conference on Big Data for Pharmacovigilance

• Author

  Jae Min Vicki Osborne Elizabeth Lynn Saad A W Shakir

  Jae Min, Vicki Osborne, Elizabeth Lynn, Saad Shakir

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  Drug Saf. 2018 Dec;41(12):1281-1284. doi: 10.1007/s40264-018-0727-2

Safety of Atrovent® CFC-free inhaler: respiratory events reported from an observational cohort study in England.

• Author

  Vicki Osborne Deborah Layton Carole Fogg Edward Tong Saad A W Shakir

  Vicki Osborne, Deborah Layton, Carole Fogg, Edward Tong, Saad Shakir

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  Int J Pharm Pract. 2018 Aug;26(4):356-363

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England.

• Author

  Vicki Osborne Miranda Davies Deborah Layton Saad A W Shakir

  Vicki Osborne, Miranda Davies, Deborah Layton, Saad Shakir

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  Drug Safety 2018 Mar;41(3):267-275.

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Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012.

• Author

  Samantha Lane Elizabeth Lynn Saad Shakir

  Samantha Lane, Elizabeth Lynn, Saad Shakir

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  BMJ Open 2018;8:e019759. doi: 10.1136/bmjopen-2017-019759

The 9th Biennial Conference on Signal Detection and Interpretation in Pharmacovigilance.

• Author

  Vicki Osborne Saad A W Shakir

  Vicki Osborne, Saad Shakir

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  Drug Saf. 2018 Jan;41(1):139-141

Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort.

• Author

  Abigail L Coughtrie Elijah R Behr Deborah Layton Vanessa Marshall A John Camm Saad A W Shakir

  Abigail Coughtrie, Elijah Behr, Deborah Layton, Vanessa Marshall, John Camm, Saad Shakir

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  BMJ Open. 2017 Oct 16;7(10):e016627.

Evidence for the hERG Liability of Antihistamines, Antipsychotics, and Anti-Infective Agents: A Systematic Literature Review From the ARITMO Project.

• Author

  Lorna Hazell Emanuel Raschi Fabrizio De Ponti Simon H L Thomas Francesco Salvo Ernst Ahlberg Helgee Scott Boyer Miriam Sturkenboom Saad Shakir

  Lorna Hazell, Emanuel Raschi, Fabrizio De Ponti, Simon Thomas, Francesco Salvo, Ernst Ahlberg Helgee, Scott Boyer, Miriam Sturkenboom, Saad Shakir

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  J Clin Pharmacol. 2017 May;57(5):558-572

Use of atomoxetine and suicidal ideation in children and adolescents: Results of an observational cohort study within general practice in England.

• Author

  M Davies A Coughtrie D Layton S A S Shakir

  Miranda Davies, Abigail Coughtrie, Deborah Layton, Saad Shakir

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  Eur Psychiatry. 2017 Jan;39:11-16.

Utilisation and Tolerability of Aliskiren in the Primary Care Setting in England.

• Author

  Abigail L Coughtrie Claire Doe Deborah Layton Saad A W Shakir

  Abigail Coughtrie, Claire Doe, Deborah Layton, Saad Shakir

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  J Clin Hypertens (Greenwich). 2016 Dec;18(12):1237-1243

Pattern of Onset and Risk Factors for Peripheral Oedema During Vildagliptin Use: Analysis from the Vildagliptin Prescription-Event Monitoring Study in England.

• Author

  Deborah Layton Abigail L. Coughtrie Naseer Qayum Saad A. W. Shakir

  Deborah Layton, Abigail Coughtrie, Naseer Qayum, Saad Shakir

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  Drug Safety 2016 Nov;39(11):1093-1104.

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Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England

• Author

  Rhian McNaughton Elizabeth Lynn Vicki Osborne Abigail Coughtrie Deborah Layton Saad Shakir

  Rhian McNaughton, Elizabeth Lynn, Vicki Osborne, Abigail Coughtrie, Deborah Layton, Saad Shakir

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  Drug Safety. April 2016, Volume 39, Issue 4, pp 323–333

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Vulnerable Patients and Potential Harms: The Contribution of Observational Research.

• Author

  Deborah Layton

  Deborah Layton

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  Drug Safety. April 2016, Volume 39, Issue 4, pp 277–280.

Utilisation of extended release quetiapine (Seroquel XL™): Results from an observational cohort study in England.

• Author

  V Osborne M Davies D Layton S A W Shakir

  Vicki Osborne, Miranda Davies, Deborah Layton, Saad Shakir

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  Eur Psychiatry. 2016 Mar;33:61-7

Sudden cardiac and sudden unexpected death related to antipsychotics: A meta-analysis of observational studies

• Author

  F Salvo A Pariente S Shakir P Robinson M Arnaud Shl Thomas E Raschi A Fourrier-Réglat N Moore M Sturkenboom L Hazell On Behalf Of Investigators Of The Aritmo Consortium Investigators of the ARITMO Consortium

  Francesco Salvo, Antoine Pariente, Saad Shakir, Philip Robinson, Mickael Arnaud, Simon Thomas, Emanuel Raschi, Annie Fourrier-Réglat, Nicholas Moore, Miriam Sturkenboom, Lorna Hazell,

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  Clin Pharmacol Ther. 2016 Mar;99(3):306-14

Contribution of UK Prescription-Based Event Monitoring Methods in the Pharmacovigilance of Psychotropic Medications

• Author

  Deborah Layton

  Deborah Layton

• Cite

  Chapter in "Pharmacovigilance in Psychiatry", 2016, edited by Edoardo Spina and Gianluca Trifirò, published by ADIS

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The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project.

• Author

  Emanuel Raschi Elisabetta Poluzzi Francesco Salvo Ariola Koci Marc Suling Stefania Antoniazzi Luisella Perina Lorna Hazell Ugo Moretti Miriam Sturkenboom Edeltraut Garbe Antoine Pariente Fabrizio De Ponti

  Emanuel Raschi, Elisabetta Poluzzi, Francesco Salvo, Ariola Koci, Marc Suling, Stefania Antoniazzi, Luisella Perina, Lorna Hazell, Ugo Moretti, Miriam Sturkenboom, Edeltraut Garbe, Antoine Pariente, Fabrizio De Ponti

• Cite

  Drug Safety 2016 Jan Volume39(1):59–68