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
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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.
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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
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Pharmacoepidemiol Drug Saf. 2022 Jun 17. doi: 10.1002/pds.5497.
Long-term safety of extended levonorgestrel-containing oral contraceptives in the United States
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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
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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
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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
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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
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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.
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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
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Journal of the Faculty of Pharmaceutical Medicine, 10 November 2020
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Challenges for Drug Repurposing in the COVID-19 Pandemia Era
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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
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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?
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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.
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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.
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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.
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Drug Saf. 2018 Jan;41(1):139-141