Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 8.138
Filtrar
5.
MMWR Morb Mortal Wkly Rep ; 70(8): 283-288, 2021 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-33630816

RESUMO

Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program (4). CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020-January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed† 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious.§ The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.


Assuntos
/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos , Adulto Jovem
8.
MMWR Morb Mortal Wkly Rep ; 70(4): 125-129, 2021 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-33507892

RESUMO

As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine (1). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours (2). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1-45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020-January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (3) and interim considerations for preparing for the potential management of anaphylaxis (4).


Assuntos
Anafilaxia/epidemiologia , Hipersensibilidade/epidemiologia , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto Jovem
9.
Cad Saude Publica ; 37(1): e00245820, 2021.
Artigo em Inglês, Português | MEDLINE | ID: mdl-33503163

RESUMO

In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher's chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student's t-test and Mann-Whitney's test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Sistemas de Notificação de Reações Adversas a Medicamentos , Brasil/epidemiologia , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Pandemias , Farmacovigilância
10.
MMWR Morb Mortal Wkly Rep ; 70(2): 46-51, 2021 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-33444297

RESUMO

As of January 3, 2021, a total of 20,346,372 cases of coronavirus disease 2019 (COVID-19) and 349,246 associated deaths have been reported in the United States. Long-term sequalae of COVID-19 over the course of a lifetime currently are unknown; however, persistent symptoms and serious complications are being reported among COVID-19 survivors, including persons who initially experience a mild acute illness.* On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine (1); initial doses were recommended for health care personnel and long-term care facility residents (2). As of December 23, 2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered in the United States, and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours (3). Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2-150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home. Of the remaining case reports that were determined not to be anaphylaxis, 86 were judged to be nonanaphylaxis allergic reactions, and 61 were considered nonallergic adverse events. Seven case reports were still under investigation. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (4) and interim considerations for preparing for the potential management of anaphylaxis (5). In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the necessary supplies available to manage anaphylaxis, should implement postvaccination observation periods, and should immediately treat persons experiencing anaphylaxis signs and symptoms with intramuscular injection of epinephrine (4,5).


Assuntos
Anafilaxia/etiologia , Hipersensibilidade/etiologia , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos , Adulto Jovem
11.
Drug Saf ; 44(1): 95-105, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33354753

RESUMO

INTRODUCTION: Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce. OBJECTIVE: This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment. METHODS: This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA®) Preferred Terms and subsequent clinical review were used to characterize COVID-19 cases. RESULTS: Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented. CONCLUSIONS: This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Indústria Farmacêutica/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Saúde Global/tendências , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Anticoagulantes/efeitos adversos , Antimaláricos/efeitos adversos , Antivirais/efeitos adversos , Bases de Dados Factuais/normas , Bases de Dados Factuais/tendências , Indústria Farmacêutica/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Saúde Global/normas , Humanos , Imunossupressores/efeitos adversos , Estudos Retrospectivos
12.
MMWR Morb Mortal Wkly Rep ; 69(5152): 1653-1656, 2021 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-33382675

RESUMO

On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 µg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.


Assuntos
/administração & dosagem , Imunização/normas , Guias de Prática Clínica como Assunto , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , Idoso , Idoso de 80 Anos ou mais , /efeitos adversos , Centers for Disease Control and Prevention, U.S. , Ensaios Clínicos Fase III como Assunto , Aprovação de Drogas , Emergências , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
13.
PLoS One ; 15(12): e0240276, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33338057

RESUMO

INTRODUCTION: Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs). OBJECTIVE: To identify the ADRs associated with the use of biological drugs in Colombia. METHODS: This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified. RESULTS: In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%). CONCLUSIONS: The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.


Assuntos
Antineoplásicos/efeitos adversos , Produtos Biológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Fatores Imunológicos/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Colômbia/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Incidência , Masculino , Segurança do Paciente , Farmacovigilância , Doenças Respiratórias/induzido quimicamente , Doenças Respiratórias/epidemiologia , Estudos Retrospectivos , Dermatopatias/induzido quimicamente , Dermatopatias/epidemiologia
14.
MMWR Morb Mortal Wkly Rep ; 69(50): 1922-1924, 2020 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-33332292

RESUMO

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 µg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.§ The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP's interim recommendation for allocating initial supplies of COVID-19 vaccines (2). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.


Assuntos
/administração & dosagem , Imunização/normas , Guias de Prática Clínica como Assunto , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Comitês Consultivos , Idoso , Idoso de 80 Anos ou mais , /prevenção & controle , Aprovação de Drogas , Humanos , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto Jovem
15.
BMC Public Health ; 20(1): 1527, 2020 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-33032559

RESUMO

BACKGROUND: Spontaneous reporting (SR) of adverse drug reactions (ADRs) from patients can be considered as a valuable activity providing both objective and subjective data. However, improving the rate of under-reporting has been a major challenge to ensure successful operation of the SR system. This study aimed to assess knowledge, attitude, and intent to report ADRs and explore the factors contributing to consumers' reporting intent in South Korea. METHODS: Self-administered questionnaire was collected from a sex-, age-, and regionally stratified nationwide convenience sample of consumers using a commercial panel in December 2018. Univariate and multivariate logistic regression analyses were used to explore the factors contributing to the intent to report ADRs by consumers. RESULTS: A total of 1000 respondents were enrolled in the survey; 50.9% were males and the mean age was 44.4 (standard deviation, 13.3) years. While less than 15% of the respondents were aware of the SR system and even fewer (3.4%) had actual experience of SR, however, 59.2% expressed their intent to report ADRs. The positive attitude (adjusted odds ratio [aOR] 3.972, p < 0.001), awareness of the SR system (aOR 2.102, p < 0.01), self-efficacy for SR (aOR 1.956, p < 0.001), and experiences related to ADR counselling with healthcare professionals (OR 2.318, p < 0.001) are the significant factors contributing to reporting intent. CONCLUSIONS: Findings of this study highlight the need for increasing the awareness of the SR system among consumers and empowering them to report ADRs by themselves, which would ultimately improve the drug-safety environment.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , Intenção , Pacientes/psicologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes/estatística & dados numéricos , República da Coreia , Inquéritos e Questionários
16.
Comput Math Methods Med ; 2020: 1391583, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33029193

RESUMO

Purpose: We aimed to analyze and evaluate the safety signals of ribavirin-interferon combination through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS), so as to provide reference for the rationale use of these agents in the management of relevant toxicities emerging in patients with novel coronavirus pneumonia (COVID-19). Methods: Reports to the FAERS from 1 January 2004 to 8 March 2020 were analyzed. The proportion of report ratio (PRR), reporting odds ratio (ROR), and Bayesian confidence interval progressive neural network (BCPNN) method were used to detect the safety signals. Results: A total of 55 safety signals were detected from the top 250 adverse event reactions in 2200 reports, but 19 signals were not included in the drug labels. All the detected adverse event reactions were associated with 13 System Organ Classes (SOC), such as gastrointestinal, blood and lymph, hepatobiliary, endocrine, and various nervous systems. The most frequent adverse events were analyzed, and the results showed that females were more likely to suffer from anemia, vomiting, neutropenia, diarrhea, and insomnia. Conclusion: The ADE (adverse drug event) signal detection based on FAERS is helpful to clarify the potential adverse events related to ribavirin-interferon combination for novel coronavirus therapy; clinicians should pay attention to the adverse reactions of gastrointestinal and blood systems, closely monitor the fluctuations of the platelet count, and carry out necessary mental health interventions to avoid serious adverse events.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Interferons/efeitos adversos , Pneumonia Viral/tratamento farmacológico , Ribavirina/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Algoritmos , Teorema de Bayes , Mineração de Dados , Esquema de Medicação , Quimioterapia Combinada/efeitos adversos , Feminino , Humanos , Interferons/administração & dosagem , Masculino , Pessoa de Meia-Idade , Redes Neurais de Computação , Razão de Chances , Pandemias , Segurança do Paciente , Ribavirina/administração & dosagem , Adulto Jovem
17.
Medicine (Baltimore) ; 99(42): e22669, 2020 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-33080709

RESUMO

Despite safety concerns associated with topiramate use, the pattern of adverse events and signal analysis of antiepileptic drugs remain elusive.We aimed to determine patient demographics and characteristics of reported AEs of topiramate and to detect the associated signals by comparing those of other antiepileptics.We used the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) from 2010 to 2017 to determine patient demographics and characteristics of reported AEs for topiramate and other antiepileptics. The proportional reporting ratio, reporting odds ratio, and information component were used in signal detection. Signals were compared against drug labels in Korea, the UK, the EU, and the US.A total of 1300 adverse events cases of topiramate were reported, and the number of topiramate-adverse event pairs was 1861. For topiramate, the proportion of women of childbearing age (20-39 years) with adverse events was more than double that for other antiepileptics. A majority of the 36 detected signals were of neuropsychiatric disorders such as cognitive disorders, concentration impaired, amnesia, hypoaesthesia. Patients with topiramate-induced adverse events were likely to be young and female. Also, adverse events related to carbonic anhydrase isoenzyme showed specifically great disproportionalities.Rigorous clinical management is needed to ensure proper and safe use of topiramate. Special precautions should be taken when prescribing in women of childbearing age.


Assuntos
Anticonvulsivantes/efeitos adversos , Topiramato/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Adulto Jovem
18.
PLoS Negl Trop Dis ; 14(9): e0008370, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32956348

RESUMO

Chagas disease (CD) and tuberculosis (TB) are important health problems in Bolivia. Current treatments for both infections require a long period of time, and adverse drug reactions (ADRs) are frequent. This study aims to strengthen the Bolivian pharmacovigilance system, focusing on CD and TB. A situation analysis of pharmacovigilance in the Department of Cochabamba was performed. The use of a new local case report form (CRF) was implemented, together with the CRF established by the Unidad de Medicamentos y Tecnología en Salud (UNIMED), in several healthcare centers. Training and follow-up on drug safety monitoring and ADR reporting was provided to all health professionals involved in CD and TB treatment. A comparative analysis of the reported ADRs using the CRF provided by UNIMED, the new CRF proposal, and medical records, was also performed. Our results showed that out of all patients starting treatment for CD, 37.9% suffered ADRs according to the medical records, and 25.3% of them were classified as moderate/severe (MS). Only 47.4% of MS ADRs were reported to UNIMED. Regarding TB treatment, 9.9% of all patients suffered ADRs, 44% of them were classified as MS, and 75% of MS ADRs were reported to UNIMED. These findings show that the reinforcement of the Bolivian pharmacovigilance system is an ambitious project that should involve a long-term perspective and the engagement of national health workers and other stakeholders at all levels. Continuity and perseverance are essential to achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to treatment.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Doença de Chagas/tratamento farmacológico , Farmacovigilância , Tuberculose/tratamento farmacológico , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Bolívia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde/educação , Humanos , Inquéritos e Questionários
20.
Zhongguo Zhong Yao Za Zhi ; 45(15): 3533-3538, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893541

RESUMO

To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Teorema de Bayes , Feminino , Humanos , Pessoa de Meia-Idade , Farmacovigilância , Gestão de Riscos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...