What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study Chiara BellittoNicoletta LuxiGianluca Trifirò Original Research Article Open access 22 June 2024
Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review Jenine ShafiManeet K. VirkRena C. Patel Review Article Open access 21 June 2024
Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance Cosimo ZaccariaLoris PiccoloCorinne de Vries Original Research Article Open access 19 June 2024
Proceedings of the Canadian Medication Appropriateness and Deprescribing Network’s 2023 National Meeting Tiphaine PiersonVerna ArcandEmily G. McDonald Meeting Report Open access 17 June 2024
Correction to: Using Social Media as a Source of Real‑World Data for Pharmaceutical Drug Development and Regulatory Decision Making Didrik WesselNicolai Pogrebnyakov Correction Open access 14 June 2024
Bridging the Evidence Gap: Sotrovimab Use in Pregnancy and the Need for Comprehensive Drug Safety Data Ursula Winterfeld Commentary 14 June 2024
Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review Frank M. C. BesagMichael J. VaseyChris Hollis Systematic Review 11 June 2024
Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies Adi MorScott FriedmanRifaat Safadi Original Research Article Open access 01 June 2024
Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations Arianna SimonettiSusan ColillaJames Matthew Higginson Original Research Article Open access 01 June 2024
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020 Mufaddal MahesriAmeet SarpatwariKatsiaryna Bykov Original Research Article 16 May 2024
Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India Upinder KaurAakanksha JaiswalSankha Shubhra Chakrabarti Original Research Article 13 May 2024
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study Anum Saqib ZaidiGregory M. PetersonMohammed S. Salahudeen Original Research Article Open access 13 May 2024
Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study Rebeccah NehardCatherine VauzelleBenoît Marin Original Research Article 13 May 2024
Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults Carina D’AiutoCarlotta LunghiHelen-Maria Vasiliadis Original Research Article 09 May 2024
Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database Renato de FilippisJohn M. KaneGeorgios Schoretsanitis Original Research Article Open access 09 May 2024
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry Diego F. WyszynskiLydia DemetriouKeele E. Wurst Original Research Article Open access 09 May 2024
Not Just Another Reporting Guideline? Here’s Why READUS-PV is a Major Step Forward Yoon K. Loke Commentary 08 May 2024 Pages: 571 - 573
A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines Souad SkalliAngela Caro-RojasMohamed A. Elhawary FROM THE ISoP 08 May 2024 Pages: 515 - 520
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers Antoine ParienteFrancesco SalvoJean-Luc Faillie Research Letter 08 May 2024
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study Samantha B. ShapiroHui YinLaurent Azoulay Original Research Article 08 May 2024
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration Michele FusaroliFrancesco SalvoCharles Khouri Original Research Article Open access 07 May 2024 Pages: 585 - 599
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement Michele FusaroliFrancesco SalvoCharles Khouri Original Research Article Open access 07 May 2024 Pages: 575 - 584
Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis Christopher A. GravelWilliam BaiAntonios Douros Original Research Article Open access 04 May 2024
The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study Ying LiLin DangYuling Shi Original Research Article Open access 30 April 2024 Pages: 711 - 719
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics Robin E. FernerJeffrey K. Aronson Current Opinion 30 April 2024
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure Vera BattiniMarianna CoccoMaurizio Sessa Original Research Article Open access 30 April 2024
Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values Bereket TesfaldetTejas PatelEileen Navarro Almario Original Research Article Open access 20 April 2024 Pages: 699 - 710
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy Brandon W. LennepJesse MackAlicia K. Morgans Review Article Open access 12 April 2024 Pages: 617 - 641
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance María Gordillo-MarañónAgnieszka SzmigielSabine Straus Original Research Article Open access 12 April 2024
Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination María Gordillo-MarañónGianmario CandoreXavier Kurz Current Opinion Open access 09 April 2024 Pages: 607 - 615
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies Joanne TreacyElaine H. MorratoJeremy Jokinen Leading Article 09 April 2024
Fatal Intoxications with Zopiclone—A Cause for Concern? Lova TrallaSara GustavssonFredrik C. Kugelberg Original Research Article Open access 27 March 2024 Pages: 687 - 697
Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea Hyunjoo KimNayeong SonEunkyung Euni Lee Original Research Article Open access 21 March 2024 Pages: 673 - 686
Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis Emanuel RaschiFrancesco SalvoCharles Khouri Editorial 18 March 2024 Pages: 601 - 605
The Role of Mitochondria in Statin-Induced Myopathy Gavin BellAnastasia ThomaAdam P. Lightfoot Review Article 16 March 2024 Pages: 643 - 653
An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older Gaël Dos SantosRaghavendra DevadigaJoon Bang Original Research Article Open access 14 March 2024 Pages: 365 - 375
The Problems with Online Health Product Sales: How can Regulations be Improved? Yi Jing SngDaryl KwokCheng Leng Chan Leading Article 14 March 2024 Pages: 529 - 533
The Role of Pharmacogenomics in Rare Diseases Alice ManGabriella S. S. GroenewegBruce C. Carleton Current Opinion 14 March 2024 Pages: 521 - 528
Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation Ling LiJannah BakerMelissa T. Baysari Original Research Article Open access 13 March 2024 Pages: 557 - 569
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE) Meredith Y. SmithElaine H. MorratoAlmut G. Winterstein Original Research Article Open access 13 March 2024 Pages: 655 - 671
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease Marjolein DrentPetal A. WijnenAalt Bast Original Research Article Open access 09 March 2024 Pages: 355 - 363
Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making Didrik WesselNicolai Pogrebnyakov Original Research Article Open access 06 March 2024 Pages: 495 - 511
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance” Fan BuFaaizah ArshadMarc A. Suchard Letter to the Editor 05 March 2024 Pages: 403 - 404
Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance” Wan-Ting HuangRobert T. ChenCaroline Cassard Letter to the Editor Open access 05 March 2024 Pages: 401 - 402
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study Jingping HuChaojin ChenChulian Gong Original Research Article 05 March 2024 Pages: 465 - 474
Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients Johanna I. WestbrookLing LiMagdalena Z. Raban Original Research Article Open access 05 March 2024 Pages: 545 - 556
Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS) Pedro L. MoroCarol EnnulatJohn R. Su Original Research Article 27 February 2024 Pages: 487 - 493
In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life Mylène TisseyreMathis CollierLaurent Chouchana Original Research Article 26 February 2024 Pages: 453 - 464
A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review Daniele SartoriJeffrey K. AronsonIgho J. Onakpoya Original Research Article Open access 24 February 2024 Pages: 475 - 485
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally Irina CaplanusiAgnieszka SzmigielSabine Straus Leading Article Open access 23 February 2024 Pages: 405 - 418