Publications

Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination.

• Author

  Samantha Lane Alison Yeomans Saad Shakir

  Samantha Lane, Alison Yeomans, Saad Shakir

• Cite

  BMJ Open. 2022 Jul 1;12(7):e060425. doi: 10.1136/bmjopen-2021-060425.

Delayed pregnancy detection and return to fertility with extended levonorgestrel-containing oral contraceptives: A real world setting cohort study

• Author

  Sigal Kaplan Monica L Bertoia Amir Lass Florence T Wang Alison Evans Sandeep Dhanda Debabrata Roy John D Seeger

  Sigal Kaplan, Monica Bertoia, Amir Lass, Florence Wang, Alison Evans, Sandeep Dhanda, Debabrata Roy, John Seeger

• Cite

  Pharmacoepidemiol Drug Saf. 2022 Jun 17. doi: 10.1002/pds.5497.

Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature

• Author

  Samantha Lane Alison Yeomans Saad Shakir

  Samantha Lane, Alison Yeomans, Saad Shakir

• Cite

  BMJ Open. 2022 May 25;12(5):e059223. doi: 10.1136/bmjopen-2021-059223.

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Rare Variation in Drug Metabolism and Long QTGenes and the Genetic Susceptibility to AcquiredLong QT Syndrome

• Author

  Belinda Gray Alban-Elouen Baruteau Albert A. Antolin Alan Pittman Giselle Sarganas Mariam Molokhia Marieke T. Blom Rachel Bastiaenen Abdenasser Bardai Silvia G. Priori Carlo Napolitano Peter E. Weeke Saad Shakir Wilhelm Haverkamp Jordi Mestres Bo Winkel Adam A. Witney Irina Chis-Ster Ajanthah Sangaralingam A. John Camm Jacob Tfelt-Hansen Dan Roden Hanno L. Tan Edeltraut Garbe Miriam Sturkenboom Elijah Behr

  Belinda Gray, Alban-Elouen Baruteau, Albert A. Antolin, Alan Pittman, Giselle Sarganas, Mariam Molokhia, Marieke T. Blom, Rachel Bastiaenen, Abdenasser Bardai, Silvia G. Priori, Carlo Napolitano, Peter E. Weeke, Saad Shakir, Wilhelm Haverkamp, Jordi Mestres, Bo Winkel, Adam A. Witney, Irina Chis-Ster, Ajanthah Sangaralingam, A. John Camm, Jacob Tfelt-Hansen, Dan Roden, Hanno L. Tan, Edeltraut Garbe, Miriam Sturkenboom, Elijah Behr

• Cite

  Circulation: Genomic and Precision Medicine Volume 15, Number 1 https://doi.org/10.1161/CIRCGEN.121.003391

Long-term safety of extended levonorgestrel-containing oral contraceptives in the United States

• Author

  Sigal Kaplan Monica L Bertoia Florence T Wang Li Zhou Amir Lass Alison Evans Sandeep Dhanda Debabrata Roy John D Seeger

  Sigal Kaplan, Monica Bertoia, Florence Wang, Li Zhou, Amir Lass, Alison Evans, Sandeep Dhanda, Debabrata Roy, John Seeger

• Cite

  Contraception. 2021 Sep 29:S0010-7824(21)00406-6. doi: 10.1016/j.contraception.2021.09.013.

A Systematic Review of Flurbiprofen 8.75mg Dose and Risk of Haemorrhagic Events

• Author

  Sandeep Dhanda Alison Evans Debabrata Roy Vicki Osborne Adam Townsley Graça Coutinho Anuraha Kulasekaran Saad Shakir

  Sandeep Dhanda, Alison Evans, Debabrata Roy, Vicki Osborne, Adam Townsley, Graca Coutinho, Anuraha Kulasekaran, Saad Shakir

• Cite

  Frontiers in Pharmacology. 2021 12:726141

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The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology

• Author

  Vicki Osborne Samantha Lane Saad A W Shakir

  Vicki Osborne, Samantha Lane, Saad Shakir

• Cite

  Drug Saf. 2021 Aug;44(8):835-841. doi: 10.1007/s40264-021-01074-y. Epub 2021 May 7.

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Utilisation and Safety of Polyethylene Glycol 3350 With Electrolytes in Children Under 2 Years: A Retrospective Cohort

• Author

  Debabrata Roy Fatma Akriche Bharat Amlani Saad Shakir

  Debabrata Roy, Fatma Akriche, Bharat Amlani, Saad Shakir

• Cite

  J Pediatr Gastroenterol Nutr. 2021 May 1;72(5):683-689. doi: 10.1097/MPG.0000000000003074.

Real world utilization of 91 day extended levonorgestrel-containing combined oral contraceptives in Europe: a multinational database study

• Author

  Sigal Kaplan Massoud Toussi Alison Evans Sandeep Dhanda Debabrata Roy Amir Lass

  Sigal Kaplan, Massoud Toussi, Alison Evans, Sandeep Dhanda, Debabrata Roy, Amir Lass

• Cite

  Curr Med Res Opin. 2021 Mar;37(3):515-522. doi: 10.1080/03007995.2021.1876008.

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How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine.

• Author

  Saad Shakir Samantha Lane Miranda Davies

  Saad Shakir, Samantha Lane, Miranda Davies

• Cite

  Drug Safety 44, 1–5 (2021). https://doi.org/10.1007/s40264-020-01018-y

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Principles of benefit-risk assessment: A focus on some practical applications

• Author

  Miranda Davies MFPM Samantha Lane Saad Shakir FFPM

  Miranda Davies, Samantha Lane, Saad Shakir

• Cite

  Journal of the Faculty of Pharmaceutical Medicine, 10 November 2020

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Challenges for Drug Repurposing in the COVID-19 Pandemia Era

• Author

  Janet Sultana Salvatore Crisafulli Flic Gabbay Elizabeth Lynn Saad Shakir Gianluca Trifirò

  Janet Sultana, Salvatore Crisafulli, Flic Gabbay, Elizabeth Lynn, Saad Shakir, Gianluca Trifirò

• Cite

  Front. Pharmacol., 06 November 2020 | https://doi.org/10.3389/fphar.2020.588654

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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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

  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

• Cite

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