Publications

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

• Author

  Vicki Osborne Saad A W Shakir

  Vicki Osborne, Saad Shakir

• Cite

  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

• Cite

  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

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Specialist Cohort Event Monitoring Studies: a New Study Method in Risk Management in Pharmacovigilance

• Author

  Deborah Layton Saad A. W. Shakir

  Deborah Layton, Saad Shakir

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  Drug Safety February 2015, Volume 38(2): 153–163

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Specialist Cohort Event Monitoring Studies: a New Study Method for Risk Management in Pharmacovigilance

• Author

  Deborah Layton Saad A. W. Shakir

  Deborah Layton, Saad Shakir

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  Drug Safety February 2015, Volume 38(2): 153–163

Implications of off-label use: An example from the final results of an observational cohort study on Intrinsa® (testosterone patch).

• Author

  Vicki Osborne Deborah Layton Saad Aw Shakir

  Vicki Osborne, Deborah Layton, Saad Shakir

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  Post Reprod Health. 2014 Jun;20(2):48-54

Utilization of fentanyl buccal tablets in England: Exploring off-label use reported in a cohort study.

• Author

  V Osborne D Layton C Fogg A Al-Shukri S A W Shakir

  Vicki Osborne, Deborah Layton, Carole Fogg, Mohammed Al-Shukri, Saad Shakir

• Cite

  Eur J Pain. 2014 Apr;18(4):506-12.

An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making.

• Author

  Rhian McNaughton Gwenaël Huet Saad Shakir

  Rhian McNaughton, Gwenaël Huet, Saad Shakir

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  BMJ Open. 2014 Jan 15;4(1)

Prescription-Event Monitoring (PEM): The evolution to the new Modified PEM and its support of risk management.

• Author

  Deborah Layton Saad Shakir

  Deborah Layton, Saad Shakir

• Cite

  Mann's Pharmacovigilance, Third Edition. Ed: E B Andrews and N Moore. John Wiley & Sons Ltd. UK. 2014

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The risk of heart failure associated with the use of noninsulin blood glucose-lowering drugs: systematic review and meta-analysis of published observational studies

• Author

  Cristina Varas-Lorenzo Andrea V Margulis Manel Pladevall Nuria Riera-Guardia Brian Calingaert Lorna Hazell Silvana Romio Susana Perez-Gutthann

  Cristina Varas-Lorenzo, Andrea Margulis, Manel Pladevall, Nuria Riera-Guardia, Brian Calingaert, Lorna Hazell, Silvana Romio, Susana Perez-Gutthann

• Cite

  BMC Cardiovascular Disorders. 2014, 14:129

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Quality assessment of observational studies in a drug-safety systematic review, comparision of two tools: the Newcastle-Ottawa Scale and the RTI item bank.

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  Margulis AV Pladevall M Riera-Guardia N Varas-Lorenzo C Hazell L Berkman N Viswanathan M Perez-Gutthann S

  Andrea Margulis, Manel Pladevall, Nuria Riera-Guardia, Cristina Varas-Lorenzo, Lorna Hazell, Nancy Berkman, Meera Viswanathan, Susana Perez-Gutthann

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  Clinical Epidemiology. 2014. Volume 6: 359-368

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Indicators of drug-seeking aberrant behaviours: The feasibility of use in observational post-marketing cohort studies for risk management.

• Author

  Deborah Layton Vicki Osborne Mohammed Al-Shukri Saad A W Shakir

  Deborah Layton, Vicki Osborne, Mohammed Al-Shukri, Saad Shakir

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  Drug Safety 2014 Volume 37(8): 639-650

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Genome wide analysis of drug-induced torsades de pointes: lack of common variants with large effect sizes.

• Author

  Elijah R Behr Marylyn D Ritchie Toshihiro Tanaka Stefan Kääb Dana C Crawford Paola Nicoletti Aris Floratos Moritz F Sinner Prince J Kannankeril Arthur A M Wilde Connie R Bezzina Eric Schulze-Bahr Sven Zumhagen Pascale Guicheney Nanette H Bishopric Vanessa Marshall Saad Shakir Chrysoula Dalageorgou Steve Bevan Yalda Jamshidi Rachel Bastiaenen Robert J Myerburg Jean-Jacques Schott A John Camm Gerhard Steinbeck Kris Norris Russ B Altman Nicolas P Tatonetti Steve Jeffery Michiaki Kubo Yusuke Nakamura Yufeng Shen Alfred L George Jr Dan M Roden

  Elijah Behr, Marylyn Ritchie, Toshihiro Tanaka, Stefan Kääb, Dana Crawford, Paola Nicoletti, Aris Floratos, Moritz F Sinner, Prince Kannankeril, Arthur Wilde, Connie Bezzina, Eric Schulze-Bahr, Sven Zumhagen, Pascale Guicheney, Nanette Bishopric, Vanessa Marshall, Saad Shakir, Chrysoula Dalageorgou, Steve Bevan, Yalda Jamshidi, Rachel Bastiaenen, Robert J Myerburg, Jean-Jacques Schott, John Camm, Gerhard Steinbeck, Kris Norris, Russ Altman, Nicholas Tatonetti, Steve Jeffery, Michiaki Kubo, Yusuke Nakamura, Yufeng Shen, Alfred George, Dan Roden

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  PLoS One. 2013 Nov 6;8(11):e78511

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England.

• Author

  Yvonne Buggy Victoria Cornelius Carole Fogg Rachna Kasliwal Deborah Layton Saad A W Shakir

  Yvonne Buggy, Victoria Cornelius, Carole Fogg, Rachna Kasliwal, Deborah Layton, Saad Shakir

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  Drug Saf. 2013 Jul;36(7):521-31.

Safety Profile of Modafinil Across a Range of Prescribing Indications, Including Off-Label Use, in a Primary Care Setting in England : Results of a Modified Prescription-Event Monitoring Study

• Author

  Miranda Davies Lynda Wilton Saad Shakir

  Miranda Davies, Lynda Wilton, Saad Shakir

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  Drug Saf. 2013 Apr;36(4):237-46

How Do Patients Contribute to Signal Detection? : A Retrospective Analysis of Spontaneous Reporting of Adverse Drug Reactions in the UK’s Yellow Card Scheme

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  Lorna Hazell Victoria Cornelius Philip Hannaford Saad Shakir Anthony J Avery Yellow Card Study Collaboration

  Lorna Hazell, Victoria Cornelius, Philip Hannaford, Saad Shakir, Anthony Avery, Yellow Card Study Collaboration

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  Drug Saf. 2013 Mar;36(3):199-206