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1.
Am J Cardiol ; 133: 77-80, 2020 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-32843146

RESUMO

Bretylium, with an extensive pharmacologic and medicinal history, was approved by the United States Food and Drug Administration in 1986 for "short-term prevention and treatment of ventricular fibrillation (VF) and treatment of life-threatening ventricular arrhythmias and ventricular tachycardia (VT) unresponsive to adequate doses of a first-line antiarrhythmic agent, such as lidocaine." The NDA sponsor withdrew bretylium from the market in 2011, largely due to unavailability of raw materials required for its production; prior to this, bretylium was removed from the 2000 ACLS Guidelines algorithm for VF/pulseless VT given the challenges obtaining raw materials for drug manufacture. Recently, bretylium has been reintroduced into the US market by a generic pharmaceutical company with the same indications as before. This article provides a history of the salient trials evaluating the efficacy and safety of bretylium and looks to the future as bretylium finds its place in the modern day management of ventricular arrhythmia.


Assuntos
Antiarrítmicos/farmacologia , Arritmias Cardíacas/tratamento farmacológico , Compostos de Bretílio/farmacologia , Recall e Retirada de Produto , Humanos
3.
N Engl J Med ; 382(7): 632-643, 2020 02 13.
Artigo em Inglês | MEDLINE | ID: mdl-32053299

RESUMO

BACKGROUND: An outbreak of listeriosis was identified in South Africa in 2017. The source was unknown. METHODS: We conducted epidemiologic, trace-back, and environmental investigations and used whole-genome sequencing to type Listeria monocytogenes isolates. A case was defined as laboratory-confirmed L. monocytogenes infection during the period from June 11, 2017, to April 7, 2018. RESULTS: A total of 937 cases were identified, of which 465 (50%) were associated with pregnancy; 406 of the pregnancy-associated cases (87%) occurred in neonates. Of the 937 cases, 229 (24%) occurred in patients 15 to 49 years of age (excluding those who were pregnant). Among the patients in whom human immunodeficiency virus (HIV) status was known, 38% of those with pregnancy-associated cases (77 of 204) and 46% of the remaining patients (97 of 211) were infected with HIV. Among 728 patients with a known outcome, 193 (27%) died. Clinical isolates from 609 patients were sequenced, and 567 (93%) were identified as sequence type 6 (ST6). In a case-control analysis, patients with ST6 infections were more likely to have eaten polony (a ready-to-eat processed meat) than those with non-ST6 infections (odds ratio, 8.55; 95% confidence interval, 1.66 to 43.35). Polony and environmental samples also yielded ST6 isolates, which, together with the isolates from the patients, belonged to the same core-genome multilocus sequence typing cluster with no more than 4 allelic differences; these findings showed that polony produced at a single facility was the outbreak source. A recall of ready-to-eat processed meat products from this facility was associated with a rapid decline in the incidence of L. monocytogenes ST6 infections. CONCLUSIONS: This investigation showed that in a middle-income country with a high prevalence of HIV infection, L. monocytogenes caused disproportionate illness among pregnant girls and women and HIV-infected persons. Whole-genome sequencing facilitated the detection of the outbreak and guided the trace-back investigations that led to the identification of the source.


Assuntos
Surtos de Doenças , Doenças Transmitidas por Alimentos/epidemiologia , Listeria monocytogenes/isolamento & purificação , Listeriose/epidemiologia , Produtos da Carne/microbiologia , Adolescente , Adulto , Idoso , Técnicas de Tipagem Bacteriana , Estudos de Casos e Controles , Feminino , Doenças Transmitidas por Alimentos/etiologia , Doenças Transmitidas por Alimentos/mortalidade , Infecções por HIV/complicações , HIV-1 , Humanos , Recém-Nascido , Listeria monocytogenes/genética , Listeriose/etiologia , Listeriose/mortalidade , Masculino , Produtos da Carne/efeitos adversos , Pessoa de Meia-Idade , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Recall e Retirada de Produto , Distribuição por Sexo , África do Sul/epidemiologia , Sequenciamento Completo do Genoma , Adulto Jovem
5.
Pediatrics ; 144(4)2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31519792

RESUMO

BACKGROUND: In 2017, we conducted a multistate investigation to determine the source of an outbreak of Shiga toxin-producing Escherichia coli (STEC) O157:H7 infections, which occurred primarily in children. METHODS: We defined a case as infection with an outbreak strain of STEC O157:H7 with illness onset between January 1, 2017, and April 30, 2017. Case patients were interviewed to identify common exposures. Traceback and facility investigations were conducted; food samples were tested for STEC. RESULTS: We identified 32 cases from 12 states. Twenty-six (81%) cases occurred in children <18 years old; 8 children developed hemolytic uremic syndrome. Twenty-five (78%) case patients ate the same brand of soy nut butter or attended facilities that served it. We identified 3 illness subclusters, including a child care center where person-to-person transmission may have occurred. Testing isolated an outbreak strain from 11 soy nut butter samples. Investigations identified violations of good manufacturing practices at the soy nut butter manufacturing facility with opportunities for product contamination, although the specific route of contamination was undetermined. CONCLUSIONS: This investigation identified soy nut butter as the source of a multistate outbreak of STEC infections affecting mainly children. The ensuing recall of all soy nut butter products the facility manufactured, totaling >1.2 million lb, likely prevented additional illnesses. Prompt diagnosis of STEC infections and appropriate specimen collection aids in outbreak detection. Child care providers should follow appropriate hygiene practices to prevent secondary spread of enteric illness in child care settings. Firms should manufacture ready-to-eat foods in a manner that minimizes the risk of contamination.


Assuntos
Surtos de Doenças/estatística & dados numéricos , Infecções por Escherichia coli/epidemiologia , Escherichia coli O157 , Doenças Transmitidas por Alimentos/epidemiologia , Escherichia coli Shiga Toxigênica , Alimentos de Soja/microbiologia , Adolescente , Idoso , Criança , Creches/estatística & dados numéricos , Pré-Escolar , Infecções por Escherichia coli/microbiologia , Fast Foods/efeitos adversos , Fast Foods/microbiologia , Feminino , Manipulação de Alimentos , Doenças Transmitidas por Alimentos/microbiologia , Síndrome Hemolítico-Urêmica/epidemiologia , Síndrome Hemolítico-Urêmica/microbiologia , Humanos , Lactente , Masculino , Recall e Retirada de Produto , Alimentos de Soja/efeitos adversos , Estados Unidos/epidemiologia
7.
Math Biosci Eng ; 15(4): 1011-1032, 2018 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-30380319

RESUMO

Human illness due to contamination of food by pathogenic strains of Escherichia coli is a serious public health concern and can cause significant economic losses in the food industry. Recent outbreaks of such illness sourced from ground beef production motivates the work in this paper. Most ground beef is produced in large facilities where many carcasses are butchered and various pieces of them are ground together in sequential batches. Assuming that the source of contamination is a single carcass and that downstream from the production facility ground beef from a particular batch has been identified as contaminated by E. coli, the probability that previous and subsequent batches are also contaminated is modelled. This model may help the beef industry to identify the likelihood of contamination in other batches and potentially save money by not needing to cook or recall unaffected batches of ground beef.


Assuntos
Escherichia coli/isolamento & purificação , Escherichia coli/patogenicidade , Microbiologia de Alimentos/estatística & dados numéricos , Carne Vermelha/microbiologia , Animais , Bovinos , Contagem de Colônia Microbiana , Surtos de Doenças/estatística & dados numéricos , Infecções por Escherichia coli/epidemiologia , Humanos , Funções Verossimilhança , Conceitos Matemáticos , Indústria de Embalagem de Carne , Probabilidade , Recall e Retirada de Produto
8.
Vet Clin North Am Small Anim Pract ; 48(6): 917-931, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30173926

RESUMO

Commercial pet foods are usually safe, but incidents of contamination can have a devastating impact on companion animals and their owners. There are numerous possible contaminants ranging from natural contaminants to nutrient imbalances to chemical adulteration, making it impossible to predict what will cause the next pet food recall. Veterinarians involvement with pet food recalls includes examining and treating affected animals, documentation and sample collection, and communicating with pet food manufacturers and regulatory agencies.


Assuntos
Ração Animal/toxicidade , Doenças do Gato/induzido quimicamente , Doenças do Cão/induzido quimicamente , Contaminação de Alimentos , Recall e Retirada de Produto , Ração Animal/análise , Animais , Autopsia/veterinária , Doenças do Gato/diagnóstico , Doenças do Gato/terapia , Gatos , Doenças do Cão/diagnóstico , Doenças do Cão/terapia , Cães , Contaminação de Alimentos/análise , Animais de Estimação , Papel Profissional , Controle Social Formal , Estados Unidos , United States Food and Drug Administration , Médicos Veterinários
9.
Artigo em Inglês | MEDLINE | ID: mdl-30134606

RESUMO

Food safety is of worldwide concern. As an effective mechanism governing food safety, food recalls are widely applied around the world. Though it is well known that food recalls can have substantial, negative impacts on corporate reputation and marketing, we know relatively little related to what factors motivate people to seek related information after the recall announcement. This study attempts to elucidate the determinants of information-seeking intention in the context of food safety in food recalls by using an augmented risk information-seeking model. A survey of 631 Chinese residents was used to explore the proposed framework. The results show that current knowledge, risk perception, perceived channel beliefs, and perceived information-gathering capacity (PIGC) are all significant predictors of information need and information-seeking intention. It was also confirmed that risk perception has a positive correlation with seeking need. These findings are important for policymakers, recalling manufacturers, and retailers to develop strategies for better risk communication in food recall announcements.


Assuntos
Inocuidade dos Alimentos , Comportamento de Busca de Informação , Modelos Teóricos , Recall e Retirada de Produto , Risco , Adolescente , Adulto , Feminino , Humanos , Intenção , Masculino , Rememoração Mental , Pessoa de Meia-Idade , Percepção , Inquéritos e Questionários , Adulto Jovem
10.
Scand J Pain ; 18(4): 667-674, 2018 10 25.
Artigo em Inglês | MEDLINE | ID: mdl-30145581

RESUMO

Background and aims Dextropropoxyphene (DXP) is a synthetic opioid that was prescribed worldwide for mild to moderate pain. It was withdrawn from the European market in 2009. In this study we aim to investigate the effect of the market withdrawal of dextropropoxyphene in Norway on overall use of opioids and other analgesics at an individual level. Methods Data were collected from the nationwide Norwegian Prescription Database (NorPD). It covers all prescription of drugs from 01 January 2004 from Norwegian pharmacies dispensed to individuals outside institutions. The study period was divided in two 2-year periods from 01 September 2008 to 31 August 2010, and from the market withdrawal of DXP on 01 September 2010 to 31 August 2012. We included every individual that filled at least one prescription of dextropropoxyphene in the first 2-year period in our study population. In this study dextropropoxyphene, codeine and tramadol are defined as "weak opioids", and all other opioids are termed "strong opioids". Results Nine thousand one hundred and seventy-one individuals were included in our study population. Four thousand two hundred and ninety filled a prescription of DXP only once and were classified as "single users", 2,990 were users with prescriptions of up to 200 defined daily doses (DDD) over the first 2-year period, or "sporadic users", and 1,886 were classified high users with over 200 DDDs over a 2-year period. After the market withdrawal 8,392 continued to be prescribed analgesics or benzodiazepines. In the single user group, the proportion of users of weak opioids decreased from 69.5% to 57.6%, whereas the proportion of users of strong opioids was unchanged. Among the sporadic user group, the proportion of users of weak opioids went from 69.7% to 71.0%, the proportion using tramadol from 39.1% to 43.9%, and the users of strong opioids from 25.8% to 31.3%. In the high user group, there was an increase in the number of users of strong opioids from 37.8% to 51.4%. The amount of strong opioids prescribed in the high user group increased from a mean of 262.5 DDD to a mean of 398.3 DDD in the following 2 years. The amount of tramadol increased in all groups and was 3 times as high in the high user group after market withdrawal of DXP. Conclusions Our study showed that the withdrawal of DXP lead to an increase in prescription of other analgesics. The proportion of users increased in all three groups and so did the prescribed amount of other analgesics. Both the proportion of users of other opioids and the amount prescribed increased considerably. However, 1 in 10 earlier users of DXP stopped using prescribed analgesics altogether in the following 2 years. The increase in use among earlier high users of DXP was most striking. Implications This study documents markedly increased prescriptions of other opioids after withdrawal of dextropropoxyphene due to its high risk of serious complications. However, consequences of the increased use of opioids among earlier high users of DXP such as changes in risk of poisonings, accidental deaths and suicides remain to be investigated.


Assuntos
Analgésicos Opioides/efeitos adversos , Dextropropoxifeno/efeitos adversos , Recall e Retirada de Produto , Bases de Dados Factuais , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Dor/epidemiologia , Estudos Prospectivos , Tramadol/uso terapêutico
12.
Artigo em Inglês | MEDLINE | ID: mdl-29562602

RESUMO

This paper addresses the public health issue of toy product recalls in the United States, an under-addressed topic in scholarly literature, yet highly relevant to the prevention of pediatric injuries. Toy-related injuries led to 274,000 emergency room visits and seven fatalities in 2016 in the United States, and toy-related injury rates have remained stable over the last five years despite declining incidences of recalls. While dangerous toys not being recalled and the misuse of "safe" products are possible contributing factors, consumer non-response to recall notices also contributes to unintentional child injury from dangerous toys. We discuss the process of recalling toys, and the role of the U.S. Consumer Product Safety Commission in that process. We also review potential factors behind significant consumer non-response to recall notifications, citing economic and psychological theories as explanations for the actions of multiple stakeholders in the recall process. We close by proposing reforms at the regulatory, consumer, and retailer levels that might boost compliance with recall notifications and ultimately reduce injury morbidity and mortality.


Assuntos
Comportamento do Consumidor , Jogos e Brinquedos , Recall e Retirada de Produto , Humanos , Incidência , Saúde Pública , Estados Unidos
13.
Nicotine Tob Res ; 20(8): 962-969, 2018 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-29069425

RESUMO

Introduction: While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and focused on cigarettes. The present longitudinal study examined recall of tobacco marketing at the POS and multiple types of tobacco use 6 months later. Methods: The Texas Adolescent Tobacco Advertising and Marketing Surveillance System (TATAMS) is a large-scale, representative study of 6th, 8th, and 10th graders in 79 middle and high schools in five counties in Texas. Weighted logistic regression examined associations between recall of tobacco advertisements and products on display at baseline and ever use, current use, and susceptibility to use for cigarette, e-cigarette, cigar, and smokeless products 6 months later. Results: Students' recall of signs marketing e-cigarettes at baseline predicted ever e-cigarette use and increased susceptibility to use e-cigarettes at follow-up, across all store types. Recall of e-cigarette displays only predicted susceptibility to use e-cigarettes at follow-up, across all store types. Both recall of signs marketing cigars and cigar product displays predicted current and ever cigar smoking and increased susceptibility to smoking cigars at follow-up, across all store types. Recall of cigarette and smokeless product marketing and displays was not associated with tobacco use measures. Conclusion: The POS environment continues to be an important influence on youth tobacco use. Restrictions on POS marketing, particularly around schools, are warranted. Implications: Cross-sectional studies have shown that exposure to POS cigarette marketing is associated with use of cigarettes among youth, though longitudinal evidence of the same is sparse and mixed. Cross-sectional studies have found that recall of cigars, smokeless product, and e-cigarette tobacco marketing at POS is associated with curiosity about tobacco use or intentions to use tobacco among youth, but limited longitudinal research has been conducted. Findings from the present longitudinal study suggest that recall of tobacco marketing at retail POS predicts ever use of e-cigarettes and cigars, current use of cigars, and susceptibility to cigar and e-cigarette use among youth.


Assuntos
Comportamento do Adolescente/psicologia , Sistemas Eletrônicos de Liberação de Nicotina , Marketing/métodos , Recall e Retirada de Produto , Produtos do Tabaco , Vaping/psicologia , Adolescente , Estudos Transversais , Feminino , Seguimentos , Previsões , Humanos , Estudos Longitudinais , Masculino , Fumar/epidemiologia , Fumar/psicologia , Estudantes/psicologia , Texas/epidemiologia , Vaping/epidemiologia
14.
Adv Ther ; 35(1): 1-4, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29285708

RESUMO

Over the past year, the FDA has issued two letters to healthcare providers alerting them to adverse events associated with ORBERA and ReShape intragastric balloons (IGBs), including several deaths. Both IGB devices were FDA-approved for use in the US in the summer of 2015. Although the adverse events cited in the two letters occurred following FDA approval, there was already evidence prior to FDA approval that the safety and efficacy of ReShape and ORBERA were highly questionable. Since January 1, 2006, ORBERA and Reshape IGB have been implicated in 33 deaths. Given the cited evidence, we recommend FDA withdrawal of these two devices.


Assuntos
Cirurgia Bariátrica/métodos , Balão Gástrico/efeitos adversos , Obesidade/cirurgia , Recall e Retirada de Produto , Aprovação de Equipamentos , Humanos , Obesidade Mórbida/cirurgia , Estados Unidos , United States Food and Drug Administration
15.
Pediatr. aten. prim ; 19(76): 329-336, oct.-dic. 2017. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-169599

RESUMO

Introducción: en junio de 2010, la Comunidad de Madrid incluyó en el calendario vacunal infantil la vacuna neumocócica conjugada tridecavalente. Por razones presupuestarias, se retiró de la financiación en julio de 2012 y hasta enero de 2015. Nuestro objetivo fue evaluar cómo influyó este hecho en la cobertura vacunal y en la incidencia de enfermedad neumocócica invasiva, neumonía y otitis media aguda en una población de recursos económicos bajos y compararlo con los mismos datos publicados para el conjunto de la región. Material y métodos: estudio de cohortes retrospectivo de los casos de enfermedad neumocócica y cobertura vacunal en los niños nacidos entre mayo de 2012 y octubre de 2014 del centro de salud Entrevías (Madrid, España). Resultados: se encuentra una menor cobertura vacunal (66%; IC 95: 57,3 a 71,4) respecto a la media de la Comunidad de Madrid (77%). No hubo casos de enfermedad neumocócica invasiva y la incidencia de neumonías y otitis fue independiente del estado vacunal. El único factor asociado a la incidencia de otitis fue la asistencia a guardería. Conclusiones: la desfinanciación de la vacuna neumocócica conjugada condicionó la disminución de la cobertura vacunal por debajo de la media regional en una población de bajos recursos. No se encontró aumento de incidencia de enfermedad neumocócica, probablemente debido a la persistencia del efecto rebaño o a un tamaño muestral insuficiente (AU)


Introduction: since June 2010 the Community of Madrid included in the childhood vaccination schedule the conjugate vaccine against thirteen pneumococcal serotypes. By budgetary reasons, it was with-drawn from the financing public system in July 2012 to March 2015. Our goal was to evaluate how it influenced vaccination coverage and the incidence of acute otitis media, pneumonia and invasive pneumococcal disease in a low-income population, and compare them with published data for the whole region. Methods and materials: retrospective cohort study of pneumococcal disease and vaccination rate in children born between May 2012 and October 2014, who are patients in the Health Center of Entrevias. Results: there has been a reduction in the vaccination coverage (66%, 95% CI: 57.3 to 71.4%) compared to the average of the Community of Madrid (77%). There were no cases of invasive pneumococcal disease, and the incidence of pneumonia and acute otitis media was independent of immunization status. The only factor associated to the incidence of acute otitis was the attendance to daycare center. Conclusions: the defunding of the conjugate vaccine against thirteen pneumococcal serotypes caused a decrease of vaccination coverage in children a low-income population. In this study we found no increased incidence of pneumococcal disease, a fact that may be due to the persistence of the herd effect or to an insufficient sample size (AU)


Assuntos
Humanos , Lactente , Masculino , Feminino , Vacinas Pneumocócicas/administração & dosagem , Infecções Pneumocócicas/prevenção & controle , Infecções Pneumocócicas/epidemiologia , Pneumonia Pneumocócica/epidemiologia , Meningite Pneumocócica/epidemiologia , Recall e Retirada de Produto , Recessão Econômica/estatística & dados numéricos
18.
J Food Prot ; 80(8): 1288-1292, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28699785

RESUMO

Data from the recalls of meat and poultry products from 2000 through 2012 due to Salmonella contamination were used to assess the factors associated with the recovery of the recalled product and to develop quantitative models to estimate the number of illnesses prevented by recalls. The percentage of product recovered following a recall action was not dependent on establishment size, recall expansions, complexity of the distribution chain, type of distribution, amount of time between the production and recall dates, or number of pounds of product recalled. However, illness-related recalls were associated with larger amounts of recalled product, smaller percentages of recalled product recovered, a greater number of days between the production date and recall date, and nationwide distribution than were recalls that were not illness related. In addition, the detection of recall-associated illnesses appeared to be enhanced in states with strong foodborne illness investigation systems. The number of Salmonella illnesses prevented by recalls was based on the number of illnesses occurring relative to the number of pounds consumed, which was then extrapolated to the number of pounds of recalled product recovered. A simulation using a program evaluation and review technique probability distribution with illness-related recalls from 2003 through 2012 estimated that there were 19,000 prevented Salmonella illnesses, after adjusting for underdiagnosis. Recalls not associated with illnesses from 2000 through 2012 prevented an estimated additional 8,300 Salmonella illnesses, after adjusting for underdiagnosis. Although further improvements to ensure accurate and complete reporting should be undertaken, our study demonstrates that recalls are an important tool for preventing additional Salmonella illnesses. Moreover, additional training resources dedicated to public health agencies for enhancing foodborne illness detection, investigations, and rapid response and reporting would further prevent illnesses.


Assuntos
Contaminação de Alimentos/análise , Recall e Retirada de Produto , Intoxicação Alimentar por Salmonella/prevenção & controle , Doenças Transmitidas por Alimentos , Humanos , Carne/microbiologia , Produtos Avícolas/microbiologia , Salmonella
20.
PLoS One ; 12(6): e0179121, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28640839

RESUMO

INTRODUCTION: Poor recall during investigations of foodborne outbreaks may lead to misclassifications in exposure ascertainment. We conducted a simulation study to assess the frequency and determinants of recall errors. METHODS: Lunch visitors in a cafeteria using exclusively cashless payment reported their consumption of 13 food servings available daily in the three preceding weeks using a self-administered paper-questionnaire. We validated this information using electronic payment information. We calculated associated factors on misclassification of recall according to time, age, sex, education level, dietary habits and type of servings. RESULTS: We included 145/226 (64%) respondents who reported 27,095 consumed food items. Sensitivity of recall was 73%, specificity 96%. In multivariable analysis, for each additional day of recall period, the adjusted chance for false-negative recall increased by 8% (OR: 1.1;95%-CI: 1.06, 1.1), for false-positive recall by 3% (OR: 1.03;95%-CI: 1.02, 1.05), for indecisive recall by 12% (OR: 1.1;95%-CI: 1.08, 1.15). Sex and education-level had minor effects. DISCUSSION: Forgetting to report consumed foods is more frequent than reporting food-items actually not consumed. Bad recall is strongly enhanced by delay of interviews and may make hypothesis generation and testing very challenging. Side dishes are more easily missed than main courses. If available, electronic payment data can improve food-history information.


Assuntos
Ingestão de Alimentos , Inocuidade dos Alimentos , Recall e Retirada de Produto , Autorrelato , Adulto , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
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