Translating Research Into Policy: A Review of Pharmacovigilance Efforts From the Southern Network On Adverse Reactions (SONAR) Group

Abstract

Abstract 4756 Introduction:SONAR, the only state-funded (South Carolina) pharmacovigilance initiative in the nation, focuses on identifying near fatal side effects of hematology and oncology therapeutics. Most safety findings are like “trees falling in the forest” – with no one hearing the noise. Our objective was to describe the outcomes from the findings of the pharmacovigilance efforts from the SONAR group. Methods:SONAR investigators reviewed practice and policy outcomes to our identification of adverse drug reactions with hematologic implications. Data sources used were PubMed, the Food and Drud Administration (FDA) files, and the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Results:DrugSONAR findingConfirmationPeak at risk per year#pts/deaths% of ADR reports in the FDA databaseFDA ResponseMarket ActionGemtuzumab for AML patientsSinusoidal-obstructive syndrome- Leukemia Research 2007Biopsy findings50,00093/67100%Black BoxDrug WithdrawnTiclopidine, clopidogrel, prasugrel (antiplatelet agents)Thrombotic Thrombocytopenic Purpura (TTP)- NEJM 2000, Lancet 1998, JAMA 1998AntibodiesTiclopidine 1 million, Clopidogrel 5 millionTiclopidine 60/20, clopidogrel 37/5, prasugrel 9/060%, 90%, and 100% respectivelyBlack Box, WarningsTiclopidine market sales < $10 million (despite being generic)Rituximab- for lymphoma treatmentPML- Blood 2009WarningsNoneNevirapine for post-HIV-exposure following exposure to blood productsFulminant hepatitis in HCWs following needle-stick- Ann of Int Med 2002Biopsy findings30/020%Dear DoctorDrug not used in this setting. CD4 thresholds added for use among HIV-infected individuals.Thalidomide, lenalidomide for multiple myeloma patientsVenous thromboembolism (VTE)- JAMA 200617,00096/1271%Warning, Dear DrVTE prophylaxis is now routine – based on survey dataVoriconazole for anti-fungal prophylaxisBreakthrough Zygomycoses following stem cell transplantation for hematologic malignancies - BMT 2007Label changeNoneEprex-formulation of EpoetinPure red cell aplasia- NEJM 2000Neutralizing antibodies208/0100%Warning, Dear DrSQ use discontinuedEpoetin, darbepoetin- cancer ptsMortality, tumor progression- JAMA 2008Black Box, warningMarked decrease in ESA use- based on survey dataMegakaryocyte growth and development factor administration to healthy volunteersLymphoid malignancies - B J of Haematology 200613/00%NoneDrug development discontinuedGranulocyte colony-stimulating factor treated cancer patientsLeukemia/MDS - JNCI 2008, B J Haematol 2006NoneNoneGemcitabinePneumonitis150/52100%Label changeCYPHER stents for coronary artery diseaseHypersensitivity at the stent siteAutopsy findings1 million12/243%Dear DoctorEnoxaparin – following coronary artery stent proceduresSevere hemorrhage and pseudoaneurysm formationKnown toxicity5/00%None Conclusions:Most SONAR findings have been followed by FDA notifications and market responses. Identifying and reporting sADRs can have marked beneficial effects on medical care. Disclosures:No relevant conflicts of interest to declare.