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
2019
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchMeSH KeywordsDrug LabelingDrug PrescriptionsDrug-Related Side Effects and Adverse ReactionsFormularies as TopicHumansMaleMedicarePrescription DrugsUnited StatesUnited States Food and Drug AdministrationConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary managementAdverse Effects of Pharmacologic Treatments of Major Depression in Older Adults
Sobieraj DM, Martinez BK, Hernandez AV, Coleman CI, Ross JS, Berg KM, Steffens DC, Baker WL. Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults. Journal Of The American Geriatrics Society 2019, 67: 1571-1581. PMID: 31140587, DOI: 10.1111/jgs.15966.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntidepressive AgentsDepressive Disorder, MajorDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleObservational Studies as TopicRandomized Controlled Trials as TopicSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake InhibitorsConceptsSerotonin-norepinephrine reuptake inhibitorsSelective serotonin reuptake inhibitorsMajor depressive disorderOverall adverse eventsAdverse eventsYears of ageStudy withdrawalAcute phaseReuptake inhibitorsObservational studyAdverse effectsChoice of antidepressantSerious adverse eventsAcute treatment phaseNorepinephrine reuptake inhibitorsSerotonin reuptake inhibitorsSpecific adverse eventsComparative long-term studiesNonpharmacologic therapiesContinuation treatmentPatients 65Pharmacologic treatmentQTc prolongationMore fallsOutpatient setting
2017
New and incremental FDA black box warnings from 2008 to 2015
Solotke MT, Dhruva SS, Downing NS, Shah ND, Ross JS. New and incremental FDA black box warnings from 2008 to 2015. Expert Opinion On Drug Safety 2017, 17: 117-123. PMID: 29215916, PMCID: PMC6013049, DOI: 10.1080/14740338.2018.1415323.Peer-Reviewed Original ResearchDrug LabelingDrug-Related Side Effects and Adverse ReactionsHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationPostmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsCohort StudiesDrug ApprovalDrug-Related Side Effects and Adverse ReactionsHumansProduct Surveillance, PostmarketingRiskSafetyUnited StatesUnited States Food and Drug AdministrationConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologics
2016
Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes
McCoy RG, Lipska KJ, Yao X, Ross JS, Montori VM, Shah ND. Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes. JAMA Internal Medicine 2016, 176: 969-78. PMID: 27273792, PMCID: PMC5380118, DOI: 10.1001/jamainternmed.2016.2275.Peer-Reviewed Original ResearchMeSH KeywordsComorbidityDiabetes Mellitus, Type 2Drug MonitoringDrug-Related Side Effects and Adverse ReactionsFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsMaleMiddle AgedNeeds AssessmentPatient Care ManagementPrevalenceRetrospective StudiesRisk AdjustmentRisk FactorsUnited StatesConceptsType 2 diabetesHigh clinical complexityRisk-adjusted probabilitySevere hypoglycemiaIntensive treatmentClinical complexityStandard treatmentIntensive glucose-lowering treatmentEnd-stage renal diseasePatient clinical complexityGlucose-lowering medicationsGlucose-lowering treatmentUse of insulinRisk of hypoglycemiaOptumLabs Data WarehouseAdults 18 yearsSerious chronic conditionsEligible patientsHbA1c levelsRenal diseaseHbA1c testEmergency departmentChronic conditionsPractice guidelinesRetrospective analysis
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 evaluationReviewRegulatory review time and post‐market safety events 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 review time and post‐market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. British Journal Of Clinical Pharmacology 2015, 80: 716-726. PMID: 25808713, PMCID: PMC4594708, DOI: 10.1111/bcp.12643.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDrug ApprovalDrug-Related Side Effects and Adverse ReactionsEuropeGovernment RegulationHumansProduct Surveillance, PostmarketingTime Factors