2022
Spontaneous reporting of post-market safety signals: what evidence should support regulatory action?
Dhodapkar MM, Ross JS, Ramachandran R. Spontaneous reporting of post-market safety signals: what evidence should support regulatory action? The BMJ 2022, 379: o2409. PMID: 36198410, DOI: 10.1136/bmj.o2409.Commentaries, Editorials and LettersAdverse Drug Reaction Reporting SystemsDatabases, FactualDrug-Related Side Effects and Adverse ReactionsHumansProduct Surveillance, PostmarketingCharacterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study
Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. The BMJ 2022, 379: e071752. PMID: 36198428, PMCID: PMC9533298, DOI: 10.1136/bmj-2022-071752.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsChild, PreschoolCross-Sectional StudiesDrug LabelingDrug-Related Side Effects and Adverse ReactionsHumansUnited StatesUnited States Food and Drug AdministrationConceptsPotential safety signalsSafety signalsSectional studyUS FoodDrug Administration Adverse Event Reporting SystemLiterature searchAdverse Event Reporting SystemSentinel InitiativeDrug Safety CommunicationsEvent Reporting SystemDrug safety signalsAdverse eventsCase seriesCase reportRegulatory actionDrug labelingSignificant associationFDA regulatory actionsComprehensive safety evaluationFAERSFDA
2015
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. Pharmacoepidemiology And Drug Safety 2015, 25: 687-694. PMID: 26554874, DOI: 10.1002/pds.3910.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCommunicationCross-Sectional StudiesDrug ApprovalDrug-Related Side Effects and Adverse ReactionsEuropean UnionHumansProduct Surveillance, PostmarketingSafety-Based Drug WithdrawalsConceptsDear Healthcare Professional CommunicationsEuropean Medicines AgencySafety eventsSafety concernsHealthcare Professional CommunicationsNovel medicinesCentralized authorization procedureEMA websitePostmarket studiesRegulatory reviewPostmarket periodMedicines AgencyWithdrawalSafety communicationMedicineSafety evaluationReview
2014
Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison
Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. PLOS ONE 2014, 9: e109100. PMID: 25333986, PMCID: PMC4204813, DOI: 10.1371/journal.pone.0109100.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCross-Sectional StudiesEuropean UnionHumansInternational AgenciesLegislation, DrugPharmaceutical PreparationsSafety-Based Drug Withdrawals
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDose