2018
Bringing Vioxx back to market
Ross JS, Krumholz HM. Bringing Vioxx back to market. The BMJ 2018, 360: k242. PMID: 29371221, DOI: 10.1136/bmj.k242.Commentaries, Editorials and Letters
2010
Licensing drugs for diabetes
Lehman R, Yudkin JS, Krumholz H. Licensing drugs for diabetes. The BMJ 2010, 341: c4805. PMID: 20819887, DOI: 10.1136/bmj.c4805.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesDiabetes Mellitus, Type 2Drug ApprovalHumansHypoglycemic AgentsRosiglitazoneSafety-Based Drug WithdrawalsThiazolidinediones
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