Publications

Free to view

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

• Cite

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

Free to view

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

• Cite

  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

• Cite

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An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making.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

• Cite

  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

Free to view

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

Free to view

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

• Author

  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

• Cite

  Clinical Epidemiology. 2014. Volume 6: 359-368

Free to view

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

• Cite

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

Free to view

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

• Cite

  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

• Cite

  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

• Cite

  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

• Author

  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

• Cite

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

Reasons for and time to discontinuation of rimonabant therapy: a Modified Prescription-Event Monitoring Study

• Author

  Marjolein J C Willemen Aukje K Mantel-Teeuwisse Yvonne Buggy Deborah Layton Sabine M J M Straus Hubert G M Leufkens Toine C G Egberts

  Marjolein Willemen, Aukje Mantel-Teeuwise, Yvonne Buggy, Deborah Layton, Sabine Straus, Hubert Leufkens, Toine Egberts

• Cite

  Drug Saf. 2012 Dec 1;35(12):1147-58

Patient versus Healthcare Professional Spontaneous Adverse Drug Reaction Reporting: A systematic review

• Author

  Jackie Inch Margaret C Watson Stella Anakwe-Umeh

  Jackie Inch, Margaret Watson, Stella Anakwe-Umeh

• Cite

  Drug Saf. 2012 Oct 1;35(10):807-18

Common variation in the NOS1AP gene is associated with drug-induced QT prolongation and ventricular arrhythmia

• Author

  Yalda Jamshidi Ilya M Nolte Chrysoula Dalageorgou Dongling Zheng Toby Johnson Rachel Bastiaenen Suzanne Ruddy Daniel Talbott Kris J Norris Harold Snieder Alfred L George Vanessa Marshall Saad Shakir Prince J Kannankeril Patricia B Munroe A John Camm Steve Jeffery Dan M Roden Elijah R Behr

  Yalda Jamshidi, Ilya Nolte, Chrysoula Dalageorgou, Dongling Zheng, Toby Johnson, Rachel Bastiaenen, Suzanne Ruddy, Daniel Talbott, Kris Norris, Harold Snieder, Alfred George, Vanessa Marshall, Saad Shakir, Prince Kannankeril, Patricia Munroe, John Camm, Steve Jeffery, Dan Roden, Elijah Behr

• Cite

  Journal of the American College of Cardiology. 2012 Aug 28;60(9):841-50

Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes

• Author

  Isla S Mackenzie Thomas M MacDonald Saad Shakir Moira Dryburgh Brian J Mantay Patrick McDonnell Deborah Layton

  Isla Mackenzie, Thomas MacDonald, Saad Shakir, Moira Dryburgh, Brian Mantay, Patrick McDonnell, Deborah Layton

• Cite

  British Journal of Clinical Pharmacology, May 2012; 73(5):801-11

A large candidate gene survey identifies the KCNE1 D85N polymorphism as a possible modulator of drug-induced torsades de pointes Kääb

• Author

  Stefan Kääb Dana C Crawford Moritz F Sinner Elijah R Behr Prince J Kannankeril Arthur A M Wilde Connie R Bezzina Eric Schulze-Bahr Pascale Guicheney Nanette H Bishopric Robert J Myerburg Jean-Jacques Schott Arne Pfeufer Britt-Maria Beckmann Eimo Martens Taifang Zhang Birgit Stallmeyer Sven Zumhagen Isabelle Denjoy Abdenasser Bardai Isabelle C Van Gelder Yalda Jamshidi Chrysoula Dalageorgou Vanessa Marshall Steve Jeffery Saad Shakir A John Camm Gerhard Steinbeck Siegfried Perz Peter Lichtner Thomas Meitinger Annette Peters H-Erich Wichmann Christiana Ingram Yuki Bradford Shannon Carter Kris Norris Marylyn D Ritchie Alfred L George Jr Dan M Roden

  Stefan Kääb, Dana Crawford, Moritz F Sinner, Elijah Behr, Prince Kannankeril, Arthur Wilde, Connie Bezzina, Eric Schulze-Bahr, Pascale Guicheney, Nanette Bishopric, Robert J Myerburg, Jean-Jacques Schott, Arne Pfeufer, Britt-Maria Beckmann, Eimo Martens, Taifang Zhang, Birgit Stallmeyer, Sven Zumhagen, Isabelle Denjoy, Abdenasser Bardai, Isabelle Van Gelder, Yalda Jamshidi, Chrysoula Dalageorgou, Vanessa Marshall, Steve Jeffery, Saad Shakir, John Camm, Gerhard Steinbeck, Siegfried Perz, Peter Lichtner, Thomas Meitinger, Annette Peters, H-Erich Wichmann, Christiana Ingram, Yuki Bradford, Shannon Carter, Kris Norris, Marylyn Ritchie, Alfred George, Dan Roden

• Cite

  Circulation: Cardiovascular Genetics. 2012 Feb 1;5(1):91-9

Free to view

Modified Prescription-Event Monitoring Studies: a tool for Pharmacovigilance and Risk Management

• Author

  Deborah Layton Lorna Hazell Saad A W Shakir

  Deborah Layton, Lorna Hazell, Saad Shakir

• Cite

  Drug Safety. 2011 December 1;34(12)

Examining the utilization and tolerability of the non-sedating antihistamine levocetirizine in England using prescription-event monitoring data

• Author

  Deborah Layton Vicki Osborne Anna Gilchrist Saad A W Shakir

  Deborah Layton, Vicki Osborne, Anna Gilchrist, Saad Shakir

• Cite

  Drug Safety. 2011 Dec 1;34(12):1177-89

Risk of depressive episodes with rimonabant: a before and after modified prescription-event monitoring study conducted in England

• Author

  Yvonne Buggy Victoria Cornelius Lynda Wilton Saad A W Shakir

  Yvonne Buggy, Victoria Cornelius, Lynda Wilton, Saad Shakir

• Cite

  Drug Safety. 2011 Jun 1;34(6):501-9

Paediatric post-marketing pharmacovigilance: comparison of the adverse event profile of vigabatrin prescribed to children and adults

• Author

  Beate Aurich-Barrera Lynda Wilton David Brown Saad Shakir

  Beate Aurich-Barrera, Lynda Wilton, David Brown, Saad Shakir

• Cite

  Pharmacoepidemiology and Drug Safety. 2011 Jun;20(6):608-18

New postgraduate qualifications in pharmacovigilance from the Drug Safety Research Unit in the UK

• Author

  Elizabeth Lynn Deborah Layton Saad Shakir

  Elizabeth Lynn, Deborah Layton, Saad Shakir

• Cite

  Drug Safety. 2011 Jan 1;34(1):89-91

Hypoglycaemia with pioglitazone: analysis of data from the Prescription-Event Monitoring study.

• Author

  Veronika Vlckova Victoria Cornelius Rachna Kasliwal Lynda Wilton Saad Shakir

  Veronika Vlckova, Victoria Cornelius, Rachna Kasliwal, Lynda Wilton, Saad Shakir

• Cite

  J Eval Clin Pract. 2010 Dec;16(6):1124-8

Paediatric postmarketing pharmacovigilance using prescription-event monitoring: a comparison of the adverse event profiles of lamotrigine prescribed in children and adults in England

• Author

  Beate Aurich-Barrera Lynda Wilton David Brown Saad Shakir

  Beate Aurich-Barrera, Lynda Wilton, David Brown, Saad Shakir

• Cite

  Drug Safety. 2010 Sep 1;33(9):751-63