Publications

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

  Lane S Yeomans A Shakir S.

  Alison Yeomans, Vicki Osborne, Saad Shakir (Global)

• Cite

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

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

• Author

  Lane S Yeomans A Shakir S.

  Shakir S.

• 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

  Kaplan S Evans A Dhanda S Roy D Bertoia ML Lass A Wang FT Seeger JD.

• Cite

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

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

• Author

  Lass A. Seeger JD. Kaplan S. Bertoia ML. Wang FT. Zhou L. Evans A. Dhanda S. Roy D.

• 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

  Dhanda S. Evans A. Roy D. Osborne V. Townsley Coutinho G. Kulasekaran A. and 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

  Saad Shakir Samantha Lane Vicki Osborne

• 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

  Roy D Shakir S. Akriche F Amlani B

• 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

  Kaplan S Toussi M Evans A Dhanda S Roy D Lass A.

• 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

  S. Shakir Lane S. & Davies M.

• 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

  Saad Shakir Lane S Davies M Shakir S

  Saad Shakir (Global)

• 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

  Shakir S Sultana J Crisafulli S Gabbay F Lynn E Trifirò G

• 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

  Evans A Roy D Davies M Shakir S Osborne V

• 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

  Dhanda S Shakir S Lynn E Osborne V

• 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

  Evans A Roy D Davies M Shakir S Osborne V

• 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

  Evans A Davies M Shakir S Osborne V

• 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

  Evans A Dhanda S Roy D Lane S Davies M Shakir S Osborne V Denyer J

• 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

  Evans A Dhanda S Roy D Lane S Davies M Shakir S Osborne V

• 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

  Shakir S Klein K Hazell L Stolk P

• 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

  Evans A Davies M Shakir S García-Rodríguez L Wallander M Friberg L Ruigomez A Schink T Bezemer I Herings R Suzart-Woischnik K Vora P Balabanova Y Soriano-Gabarró M Brobert G

• 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

  Roy D Davies M Shakir S Osborne V Tescione F

• 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

  Lynn E Osborne V Min J Shakir SAW

• 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

  Osborne V Layton D Shakir SAW. Fogg C Tong E

• 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

  Davies M Osborne V Layton D Shakir SAW.

• 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

  Saad Shakir Samantha Lane Elizabeth Lynn

• Cite

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

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

• Author

  Osborne V Shakir SAW

• Cite

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