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[PMID]:29371221
[Au] Autor:Ross JS; Krumholz HM
[Ad] Endereço:Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
[Ti] Título:Bringing Vioxx back to market.
[So] Source:BMJ;360:k242, 2018 01 25.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Artralgia/tratamento farmacológico
Aprovação de Drogas
Lactonas/efeitos adversos
Retirada de Medicamento Baseada em Segurança
Sulfonas/efeitos adversos
[Mh] Termos MeSH secundário: Artralgia/etiologia
Hemofilia A/complicações
Seres Humanos
[Pt] Tipo de publicação:EDITORIAL; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
[Nm] Nome de substância:
0 (Lactones); 0 (Sulfones); 0QTW8Z7MCR (rofecoxib)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180127
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.k242


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[PMID]:28461037
[Au] Autor:Aronson JK
[Ad] Endereço:Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Oxford OX2 6GG, United Kingdom. Electronic address: jeffrey.aronson@phc.ox.ac.uk.
[Ti] Título:Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems.
[So] Source:Therapie;72(5):555-561, 2017 Oct.
[Is] ISSN:0040-5957
[Cp] País de publicação:France
[La] Idioma:eng
[Ab] Resumo:Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa, where withdrawals are fewer than elsewhere, should be strengthened.
[Mh] Termos MeSH primário: Sistemas de Notificação de Reações Adversas a Medicamentos
Retirada de Medicamento Baseada em Segurança/estatística & dados numéricos
[Mh] Termos MeSH secundário: Seres Humanos
Farmacovigilância
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171228
[Lr] Data última revisão:
171228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE


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[PMID]:28986441
[Au] Autor:Robison SG; Dunn AG; Richards DL; Leman RF
[Ad] Endereço:Immunization Program and steve.g.robison@state.or.gov.
[Ti] Título:Changes in Influenza Vaccination Rates After Withdrawal of Live Vaccine.
[So] Source:Pediatrics;140(5), 2017 Nov.
[Is] ISSN:1098-4275
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Before the start of the 2016-2017 influenza season, the Advisory Committee on Immunization Practices withdrew its recommendation promoting the use of live attenuated influenza vaccines (LAIVs). There was concern that this might lessen the likelihood that those with a previous LAIV would return for an injectable influenza vaccine (IIV) and that child influenza immunization rates would decrease overall. METHODS: Using Oregon's statewide immunization registry, the ALERT Immunization Information System, child influenza immunization rates were compared across the 2012-2013 through 2016-2017 seasons. Additionally, matched cohorts of children were selected based on receipt of either an LAIV or an IIV during the 2015-2016 season. Differences between the IIV and LAIV cohorts in returning for the IIV in the 2016-2017 season were assessed. RESULTS: Overall, influenza immunization rates for children aged 2 to 17 years were unchanged between the 2015-2016 and 2016-2017 seasons. Children aged 3 to 10 with a previous IIV were 1.03 (95% confidence interval, 1.02 to 1.04) times more likely to return for an IIV in 2016-2017 than those with a previous LAIV, whereas children aged 11 to 17 years with a previous IIV were 1.08 (95% confidence interval, 1.05 to -1.09) times more likely to return. CONCLUSIONS: Withdrawal of the LAIV recommendation was not associated with an overall change in child influenza immunization rates across seasons. Children with a previous (2015-2016) IIV were slightly more likely to return during the 2016-2017 season for influenza immunization than those with a previous LAIV.
[Mh] Termos MeSH primário: Imunização/tendências
Vacinas contra Influenza/uso terapêutico
Influenza Humana/epidemiologia
Influenza Humana/prevenção & controle
Retirada de Medicamento Baseada em Segurança/tendências
[Mh] Termos MeSH secundário: Adolescente
Criança
Pré-Escolar
Estudos de Coortes
Feminino
Seres Humanos
Masculino
Oregon/epidemiologia
Sistema de Registros
Estações do Ano
Vacinas Atenuadas/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Influenza Vaccines); 0 (Vaccines, Attenuated)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171008
[St] Status:MEDLINE


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[PMID]:28585310
[Au] Autor:Jakobsen JC; Nielsen EE; Feinberg J; Katakam KK; Fobian K; Hauser G; Poropat G; Djurisic S; Weiss KH; Bjelakovic M; Bjelakovic G; Klingenberg SL; Liu JP; Nikolova D; Koretz RL; Gluud C
[Ad] Endereço:The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Sjælland, Denmark, DK-2100.
[Ti] Título:Direct-acting antivirals for chronic hepatitis C.
[So] Source:Cochrane Database Syst Rev;6:CD012143, 2017 06 06.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Millions of people worldwide suffer from hepatitis C, which can lead to severe liver disease, liver cancer, and death. Direct-acting antivirals (DAAs) are relatively new and expensive interventions for chronic hepatitis C, and preliminary results suggest that DAAs may eradicate hepatitis C virus (HCV) from the blood (sustained virological response). However, it is still questionable if eradication of hepatitis C virus in the blood eliminates hepatitis C in the body, and improves survival and leads to fewer complications. OBJECTIVES: To assess the benefits and harms of DAAs in people with chronic HCV. SEARCH METHODS: We searched for all published and unpublished trials in The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, LILACS, and BIOSIS; the Chinese Biomedical Literature Database (CBM), China Network Knowledge Information (CNKI), the Chinese Science Journal Database (VIP), Google Scholar, The Turning Research into Practice (TRIP) Database, ClinicalTrials.gov, European Medicines Agency (EMA) (www.ema.europa.eu/ema/), WHO International Clinical Trials Registry Platform (www.who.int/ictrp), the Food and Drug Administration (FDA) (www.fda.gov), and pharmaceutical company sources for ongoing or unpublished trials. Searches were last run in October 2016. SELECTION CRITERIA: Randomised clinical trials comparing DAAs versus no intervention or placebo, alone or with co-interventions, in adults with chronic HCV. We included trials irrespective of publication type, publication status, and language. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcomes were hepatitis C-related morbidity, serious adverse events, and quality of life. Our secondary outcomes were all-cause mortality, ascites, variceal bleeding, hepato-renal syndrome, hepatic encephalopathy, hepatocellular carcinoma, non-serious adverse events (each reported separately), and sustained virological response. We systematically assessed risks of bias, performed Trial Sequential Analysis, and followed an eight-step procedure to assess thresholds for statistical and clinical significance. The overall quality of the evidence was evaluated using GRADE. MAIN RESULTS: We included a total of 138 trials randomising a total of 25,232 participants. The 138 trials assessed the effects of 51 different DAAs. Of these, 128 trials employed matching placebo in the control group. All included trials were at high risk of bias. Eighty-four trials involved DAAs on the market or under development (13,466 participants). Fifty-seven trials administered withdrawn or discontinued DAAs. Trial participants were treatment-naive (95 trials), treatment-experienced (17 trials), or both treatment-naive and treatment-experienced (24 trials). The HCV genotypes were genotype 1 (119 trials), genotype 2 (eight trials), genotype 3 (six trials), genotype 4 (nine trials), and genotype 6 (one trial). We identified two ongoing trials.Meta-analysis of the effects of all DAAs on the market or under development showed no evidence of a difference when assessing hepatitis C-related morbidity or all-cause mortality (OR 3.72, 95% CI 0.53 to 26.18, P = 0.19, I² = 0%, 2,996 participants, 11 trials, very low-quality evidence). As there were no data on hepatitis C-related morbidity and very few data on mortality (DAA 15/2377 (0.63%) versus control 1/617 (0.16%)), it was not possible to perform Trial Sequential Analysis on hepatitis C-related morbidity or all-cause mortality.Meta-analysis of all DAAs on the market or under development showed no evidence of a difference when assessing serious adverse events (OR 0.93, 95% CI 0.75 to 1.15, P = 0.52, I² = 0%, 15,817 participants, 43 trials, very low-quality evidence). The Trial Sequential Analysis showed that the cumulative Z-score crossed the trial sequential boundary for futility, showing that there was sufficient information to rule out that DAAs compared with placebo reduced the relative risk of a serious adverse event by 20%. The only DAA that showed a significant difference on risk of serious adverse events when meta-analysed separately was simeprevir (OR 0.62, 95% CI 0.45 to 0.86). However, Trial Sequential Analysis showed that there was not enough information to confirm or reject a relative risk reduction of 20%, and when one trial with an extreme result was excluded, then the meta-analysis result showed no evidence of a difference.DAAs on the market or under development seemed to reduce the risk of no sustained virological response (RR 0.44, 95% CI 0.37 to 0.52, P < 0.00001, I² = 77%, 6886 participants, 32 trials, very low-quality evidence) and Trial Sequential Analysis confirmed this meta-analysis result.Only 1/84 trials on the market or under development assessed the effects of DAAs on health-related quality of life (SF-36 mental score and SF-36 physical score).Withdrawn or discontinued DAAs had no evidence of a difference when assessing hepatitis C-related morbidity and all-cause mortality (OR 0.64, 95% CI 0.23 to 1.79, P = 0.40, I² = 0%; 5 trials, very low-quality evidence). However, withdrawn DAAs seemed to increase the risk of serious adverse events (OR 1.45, 95% CI 1.22 to 1.73, P = 0.001, I² = 0%, 29 trials, very low-quality evidence), and Trial Sequential Analysis confirmed this meta-analysis result.Most of all outcome results were short-term results; therefore, we could neither confirm nor reject any long-term effects of DAAs. None of the 138 trials provided useful data to assess the effects of DAAs on the remaining secondary outcomes (ascites, variceal bleeding, hepato-renal syndrome, hepatic encephalopathy, and hepatocellular carcinoma). AUTHORS' CONCLUSIONS: Overall, DAAs on the market or under development do not seem to have any effects on risk of serious adverse events. Simeprevir may have beneficial effects on risk of serious adverse event. In all remaining analyses, we could neither confirm nor reject that DAAs had any clinical effects. DAAs seemed to reduce the risk of no sustained virological response. The clinical relevance of the effects of DAAs on no sustained virological response is questionable, as it is a non-validated surrogate outcome. All trials and outcome results were at high risk of bias, so our results presumably overestimate benefit and underestimate harm. The quality of the evidence was very low.
[Mh] Termos MeSH primário: Antivirais/uso terapêutico
Hepatite C Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Antivirais/efeitos adversos
Causas de Morte
Hepacivirus/efeitos dos fármacos
Hepatite C Crônica/complicações
Hepatite C Crônica/mortalidade
Seres Humanos
Inibidores da Síntese de Ácido Nucleico/efeitos adversos
Inibidores da Síntese de Ácido Nucleico/uso terapêutico
Placebos/uso terapêutico
Inibidores de Proteases/efeitos adversos
Inibidores de Proteases/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Retirada de Medicamento Baseada em Segurança
Simeprevir/efeitos adversos
Simeprevir/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Nucleic Acid Synthesis Inhibitors); 0 (Placebos); 0 (Protease Inhibitors); 9WS5RD66HZ (Simeprevir)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171102
[Lr] Data última revisão:
171102
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170607
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD012143.pub2


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[PMID]:28551309
[Au] Autor:Wang Z; Zheng Q; Zhang H; Bronson RT; Madsen JC; Sachs DH; Huang CA; Wang Z
[Ad] Endereço:Center for Transplantation Sciences, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
[Ti] Título:Ontak-like human IL-2 fusion toxin.
[So] Source:J Immunol Methods;448:51-58, 2017 Sep.
[Is] ISSN:1872-7905
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Ontak® is a FDA-approved diphtheria toxin-based recombinant fusion toxin for treatment of human CD25 cutaneous T cell lymphoma (CTCL). However, it has been discontinued clinically due to the production issue related to the bacterial expression system with difficult purification. Recently we have developed monovalent and bivalent human IL-2 fusion toxins targeting human CD25 cells using advanced unique diphtheria toxin resistant yeast Pichia Pastoris expression system. In vitro efficacy characterization using human CD25 HUT102/6TG cells demonstrated that both monovalent and bivalent isoforms are potent and the bivalent isoform is approximately two logs more potent than the monovalent isoform. In this study, we further assessed the in vivo efficacy of the human IL-2 fusion toxins using human CD25 HUT102/6TG tumor-bearing NSG mouse model. The data demonstrated that both monovalent and bivalent human IL-2 fusion toxins significantly prolonged the survival of the human CD25 tumor-bearing NSG mice in a dose-dependent manner. Then we further assessed the residual tumor cells from the HUT102/6TG tumor-bearing NSG mice using the residual tumor cell bearing NSG mouse model. The results demonstrated that the residual tumor cells were still sensitive to the continual treatment with the human IL-2 fusion toxin. This yeast-expressed human IL-2 fusion toxin will be a promising candidate to replace the clinically discontinued Ontak®.
[Mh] Termos MeSH primário: Antineoplásicos/farmacologia
Toxina Diftérica/farmacologia
Imunoconjugados/farmacologia
Interleucina-2/farmacologia
Linfoma Cutâneo de Células T/tratamento farmacológico
Neoplasias Cutâneas/tratamento farmacológico
[Mh] Termos MeSH secundário: Animais
Antineoplásicos/metabolismo
Antineoplásicos/toxicidade
Linhagem Celular Tumoral
Toxina Diftérica/toxicidade
Relação Dose-Resposta a Droga
Seres Humanos
Imunoconjugados/genética
Imunoconjugados/metabolismo
Imunoconjugados/toxicidade
Interleucina-2/biossíntese
Interleucina-2/genética
Interleucina-2/toxicidade
Subunidade alfa de Receptor de Interleucina-2/imunologia
Subunidade alfa de Receptor de Interleucina-2/metabolismo
Linfoma Cutâneo de Células T/imunologia
Linfoma Cutâneo de Células T/patologia
Camundongos Endogâmicos NOD
Camundongos Knockout
Camundongos SCID
Pichia/genética
Pichia/metabolismo
Proteínas Recombinantes de Fusão/farmacologia
Proteínas Recombinantes de Fusão/toxicidade
Retirada de Medicamento Baseada em Segurança
Neoplasias Cutâneas/imunologia
Neoplasias Cutâneas/patologia
Fatores de Tempo
Carga Tumoral/efeitos dos fármacos
Ensaios Antitumorais Modelo de Xenoenxerto
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Diphtheria Toxin); 0 (IL2 protein, human); 0 (IL2RA protein, human); 0 (Immunoconjugates); 0 (Interleukin-2); 0 (Interleukin-2 Receptor alpha Subunit); 0 (Recombinant Fusion Proteins); 25E79B5CTM (denileukin diftitox)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170529
[St] Status:MEDLINE


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[PMID]:28325450
[Au] Autor:Onay A; Onay M; Abul O
[Ad] Endereço:Department of Computer Engineering, TOBB University of Economics & Technology, 06560, Ankara, Turkey.
[Ti] Título:Classification of nervous system withdrawn and approved drugs with ToxPrint features via machine learning strategies.
[So] Source:Comput Methods Programs Biomed;142:9-19, 2017 Apr.
[Is] ISSN:1872-7565
[Cp] País de publicação:Ireland
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND OBJECTIVES: Early-phase virtual screening of candidate drug molecules plays a key role in pharmaceutical industry from data mining and machine learning to prevent adverse effects of the drugs. Computational classification methods can distinguish approved drugs from withdrawn ones. We focused on 6 data sets including maximum 110 approved and 110 withdrawn drugs for all and nervous system diseases to distinguish approved drugs from withdrawn ones. METHODS: In this study, we used support vector machines (SVMs) and ensemble methods (EMs) such as boosted and bagged trees to classify drugs into approved and withdrawn categories. Also, we used CORINA Symphony program to identify Toxprint chemotypes including over 700 predefined chemotypes for determination of risk and safety assesment of candidate drug molecules. In addition, we studied nervous system withdrawn drugs to determine the key fragments with The ParMol package including gSpan algorithm. RESULTS: According to our results, the descriptors named as the number of total chemotypes and bond CN_amine_aliphatic_generic were more significant descriptors. The developed Medium Gaussian SVM model reached 78% prediction accuracy on test set for drug data set including all disease. Here, bagged tree and linear SVM models showed 89% of accuracies for phycholeptics and psychoanaleptics drugs. A set of discriminative fragments in nervous system withdrawn drug (NSWD) data sets was obtained. These fragments responsible for the drugs removed from market were benzene, toluene, N,N-dimethylethylamine, crotylamine, 5-methyl-2,4-heptadiene, octatriene and carbonyl group. CONCLUSION: This paper covers the development of computational classification methods to distinguish approved drugs from withdrawn ones. In addition, the results of this study indicated the identification of discriminative fragments is of significance to design a new nervous system approved drugs with interpretation of the structures of the NSWDs.
[Mh] Termos MeSH primário: Simulação por Computador
Sistema Nervoso/efeitos dos fármacos
Retirada de Medicamento Baseada em Segurança/estatística & dados numéricos
Máquina de Vetores de Suporte
[Mh] Termos MeSH secundário: Algoritmos
Área Sob a Curva
Benzeno/toxicidade
Carbono
Mineração de Dados
Aprovação de Drogas
Monitoramento de Medicamentos
Etilaminas/toxicidade
Reações Falso-Positivas
Seres Humanos
Modelos Lineares
Segurança do Paciente
Reconhecimento Automatizado de Padrão/métodos
Preparações Farmacêuticas/química
Vigilância de Produtos Comercializados/normas
Risco
Sensibilidade e Especificidade
Tolueno/toxicidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Ethylamines); 0 (Pharmaceutical Preparations); 3FPU23BG52 (Toluene); 7440-44-0 (Carbon); 9N5384XVEM (N,N-dimethylethylamine); J64922108F (Benzene)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171002
[Lr] Data última revisão:
171002
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170323
[St] Status:MEDLINE


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[PMID]:28058826
[Ti] Título:Detection of Sabin-like type 2 poliovirus after global cessation of trivalent oral poliovirus vaccine in Hyderabad and Ahmedabad, India, August­September 2016.
[Ti] Título:Détection de poliovirus de type 2 dérivés de la souche Sabin à Hyderabad et Ahmedabad (Inde) en août-septembre 2016 après l'abandon du vaccine antipoliomyélitique oral trivalent à l'échelle mondiale..
[So] Source:Wkly Epidemiol Rec;92(1):9-11, 2017 01 06.
[Is] ISSN:0049-8114
[Cp] País de publicação:Switzerland
[La] Idioma:eng; fre
[Mh] Termos MeSH primário: Vacina Antipólio Oral
Poliovirus/isolamento & purificação
Esgotos/virologia
[Mh] Termos MeSH secundário: Sequência de Bases
Armazenamento de Medicamentos/estatística & dados numéricos
Saúde Global
Seres Humanos
Índia
Poliovirus/genética
Vacina Antipólio Oral/administração & dosagem
Vacina Antipólio Oral/provisão & distribuição
Setor Privado
Retirada de Medicamento Baseada em Segurança
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Poliovirus Vaccine, Oral); 0 (Sewage)
[Em] Mês de entrada:1701
[Cu] Atualização por classe:170131
[Lr] Data última revisão:
170131
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170107
[St] Status:MEDLINE


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[PMID]:27924687
[Au] Autor:Levi M; Sinisgalli E; Lorini C; Santomauro F; Chellini M; Bonanni P
[Ad] Endereço:a Department of Health Sciences , University of Florence , Florence , Italy.
[Ti] Título:The "Fluad Case" in Italy: Could it have been dealt differently?
[So] Source:Hum Vaccin Immunother;13(2):379-384, 2017 Feb.
[Is] ISSN:2164-554X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:During the influenza vaccination campaign 2014-2015, the reporting of 3 deaths within 48 hours of vaccination with Fluad brought the Italian Medicines Agency (AIFA) to pronounce the withdrawal of 2 batches of vaccine, based on the precautionary principle. Investigations by the Italian National Institute of Health, and by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee at the European Medicines Agency (EMA) responsible for monitoring and assessing the safety profiles of human drugs, concluded that there was a lack of causality between the reported deaths and the vaccines administered. However, the media impact of the decision taken by AIFA, resulted in a lower influenza vaccination coverage compared with the previous years. The aim of our study was to identify possible critical points that may have led to a non-perfect management of the event. A review of the regulatory framework in place was performed, with a particular focus on the Guidelines on Good Pharmacovigilance Practices developed by the EMA to facilitate the signal management process. The management of reports involves the following steps: signal detection, its validation and confirmation, analysis and prioritization, assessment, recommendations for action and the exchange of information. In our opinion, both the signal detection phase and the phase of validation have been critical: the withdrawal of vaccine batches is possible even in case of a single suspected serious adverse reaction. However, aspects such as the biological plausibility, the presence of potential alternative causes and previous awareness should also be considered. Furthermore, the number of reported deaths was consistent with the expected background mortality rate in the vaccinated cohort. The disproportionate media coverage given to the AIFA decision resulted in a reduced vaccine confidence in the general population and in a decreased immunization coverage. Improving the communication on vaccine safety issues is crucial at this stage to restore a climate of trust in this powerful tool for primary prevention.
[Mh] Termos MeSH primário: Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade
Comunicação em Saúde
Influenza Humana/prevenção & controle
Retirada de Medicamento Baseada em Segurança
Vacinação/efeitos adversos
Vacinas/efeitos adversos
[Mh] Termos MeSH secundário: Seres Humanos
Vacinas contra Influenza
Itália
Vacinas/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Influenza Vaccines); 0 (Vaccines); 0 (fluad vaccine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161208
[St] Status:MEDLINE
[do] DOI:10.1080/21645515.2017.1264738


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[PMID]:27394662
[Au] Autor:Sreekumar V; Aspera-Werz RH; Tendulkar G; Reumann MK; Freude T; Breitkopf-Heinlein K; Dooley S; Pscherer S; Ochs BG; Flesch I; Hofmann V; Nussler AK; Ehnert S
[Ad] Endereço:Siegfried Weller Institute for Trauma Research at the BG Trauma Center, Eberhard Karls Universität Tübingen, Schnarrenbergstr. 95, 72076, Tübingen, Germany.
[Ti] Título:BMP9 a possible alternative drug for the recently withdrawn BMP7? New perspectives for (re-)implementation by personalized medicine.
[So] Source:Arch Toxicol;91(3):1353-1366, 2017 Mar.
[Is] ISSN:1432-0738
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Promotion of rhBMP2 and rhBMP7 for the routine use to support fracture healing has been hampered by high costs, safety concerns and reasonable failure rates, imposing restrictions in its clinical use. Since there is little debate regarding its treatment potential, there is rising need for a better understanding of the mode of action of these BMPs to overcome its drawbacks and promote more efficacious treatment strategies for bone regeneration. Recently, BMP9, owing to its improved osteogenic potential, is gaining attention as a promising therapeutic alternative. Our study aimed at identifying specific gene expression patterns which may predict and explain individual responses to rhBMP7 and rhBMP9 treatments. Therefore, we investigated the effect of rhBMP7 and rhBMP9 on primary human osteoblasts from 110 donors and corresponding THP-1-derived osteoclasts. This was further compared with each other and our reported data on rhBMP2 response. Based on the individual donor response, we found three donor groups profiting from rhBMP treatment either directly via stimulation of osteoblast function or viability and/or indirectly via inhibition of osteoclasts. The response on rhBMP7 treatment correlated with expression levels of the genes BAMBI, SOST, Noggin, Smad4 and RANKL, while the response of rhBMP9 correlated to the expression levels of Alk6, Endoglin, Smurf1, Smurf2, SOST and RANKL in these donors. Noteworthy, rhBMP9 treatment showed significantly increased osteogenic activity (AP activity and Smad nuclear translocation) when compared to the two clinically used rhBMPs. Based on patient's respective expression profiles, clinical application of rhBMP9 either solely or in combination with rhBMP2 and/or rhBMP7 can become a promising new approach to fit the patient's needs to promote fracture healing.
[Mh] Termos MeSH primário: Fator 2 de Diferenciação de Crescimento/farmacologia
Osteoblastos/efeitos dos fármacos
[Mh] Termos MeSH secundário: Fosfatase Alcalina/metabolismo
Proteína Morfogenética Óssea 2/farmacologia
Proteína Morfogenética Óssea 7/farmacologia
Proteínas Morfogenéticas Ósseas/genética
Proteínas Morfogenéticas Ósseas/metabolismo
Sobrevivência Celular/efeitos dos fármacos
Células Cultivadas
Regulação da Expressão Gênica/efeitos dos fármacos
Fator 2 de Diferenciação de Crescimento/genética
Seres Humanos
Osteoblastos/metabolismo
Osteoprotegerina/genética
Osteoprotegerina/metabolismo
Ligante RANK/genética
Ligante RANK/metabolismo
Proteínas Recombinantes/farmacologia
Retirada de Medicamento Baseada em Segurança
Proteínas Wnt/genética
Proteínas Wnt/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Bone Morphogenetic Protein 2); 0 (Bone Morphogenetic Protein 7); 0 (Bone Morphogenetic Proteins); 0 (Growth Differentiation Factor 2); 0 (Osteoprotegerin); 0 (RANK Ligand); 0 (Recombinant Proteins); 0 (TNFSF11 protein, human); 0 (Wnt Proteins); EC 3.1.3.1 (Alkaline Phosphatase)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170306
[Lr] Data última revisão:
170306
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160711
[St] Status:MEDLINE
[do] DOI:10.1007/s00204-016-1796-6


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[PMID]:26781296
[Au] Autor:Banerjee T; Nayak A
[Ad] Endereço:Department of Economics, Auburn University, Auburn, AL, USA. tzb0018@auburn.edu.
[Ti] Título:Why trash don't pass? pharmaceutical licensing and safety performance of drugs.
[So] Source:Eur J Health Econ;18(1):59-71, 2017 Jan.
[Is] ISSN:1618-7601
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.
[Mh] Termos MeSH primário: Descoberta de Drogas
Indústria Farmacêutica/legislação & jurisprudência
Licenciamento/legislação & jurisprudência
Retirada de Medicamento Baseada em Segurança
[Mh] Termos MeSH secundário: Aprovação de Drogas
Seres Humanos
Vigilância de Produtos Comercializados
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171014
[Lr] Data última revisão:
171014
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160120
[St] Status:MEDLINE
[do] DOI:10.1007/s10198-015-0758-x



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