Adverse reactions of anti‐tuberculosis drugs in hospitalized patients: incidence, severity and risk factors

Javadi, Mohammad Reza; Shalviri, Gloria; Gholami, Kheirollah; Salamzadeh, Jamshid; Maghooli, Golshan; Mirsaeedi, Seid Mahdi

doi:10.1002/pds.1468

Cited by 43 publications

(53 citation statements)

References 9 publications

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“…Similar to findings in earlier studies in drug-sensitive TB[16], [17], [21], a higher number of women experienced AEs. The reason for this remains unclear.…”

Section: Discussionsupporting

confidence: 89%

Drug-Associated Adverse Events and Their Relationship with Outcomes in Patients Receiving Treatment for Extensively Drug-Resistant Tuberculosis in South Africa

et al. 2013

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BackgroundTreatment-related outcomes in patients with extensively drug-resistant tuberculosis (XDR-TB) are poor. However, data about the type, frequency and severity of presumed drug-associated adverse events (AEs) and their association with treatment-related outcomes in patients with XDR-TB are scarce.MethodsCase records of 115 South-African XDR-TB patients were retrospectively reviewed by a trained researcher. AEs were estimated and graded according to severity [grade 0 = none; grade 1–2 = mild to moderate; and grade 3–5 = severe (drug stopped, life-threatening or death)].Findings161 AEs were experienced by 67/115(58%) patients: 23/67(34%) required modification of treatment, the offending drug was discontinued in 19/67(28%), reactions were life-threatening in 2/67(3.0%), and 6/67(9.0%) died. ∼50% of the patients were still on treatment at the time of data capture. Sputum culture-conversion was less likely in those with severe (grade 3–5) vs. grade 0–2 AEs [2/27(7%) vs. 24/88(27%); p = 0.02]. The type, frequency and severity of AEs was similar in HIV-infected and uninfected patients. Capreomycin, which was empirically administered in most cases, was withdrawn in 14/104(14%) patients, implicated in (14/34) 41% of the total drug withdrawals, and was associated with all 6 deaths in the severe AE group (renal failure in five patients and hypokalemia in one patient).ConclusionDrug-associated AEs occur commonly with XDR-TB treatment, are often severe, frequently interrupt therapy, and negatively impact on culture conversion outcomes. These preliminary data inform on the need for standardised strategies (including pre-treatment counselling, early detection, monitoring, and follow-up) and less toxic drugs to optimally manage patients with XDR-TB.

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“…Similar to findings in earlier studies in drug-sensitive TB[16], [17], [21], a higher number of women experienced AEs. The reason for this remains unclear.…”

Section: Discussionsupporting

confidence: 89%

Drug-Associated Adverse Events and Their Relationship with Outcomes in Patients Receiving Treatment for Extensively Drug-Resistant Tuberculosis in South Africa

et al. 2013

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“…In another survey at infectious disease department of a hospital in Iran, 2.2% of all admissions were due to anti-infective ADRs (Gholami et al, 2005). In two further studies in Iranian population, the rate of ADRs causing hospitalization in infectious disease and internal medicine wards were 5.4% (Javadi et al, 2007). and 1.75% (Pourseyed et al, 2009), respectively.…”

Section: Discussionmentioning

confidence: 94%

Cardiovascular drug adverse reactions in hospitalized patients in cardiac care unit

Karimzadeh¹,

Namazi²,

Shalviri³

et al. 2011

Afr. J. Pharm. Pharmacol.

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The aim of the present survey was to evaluate different aspects of cardiovascular drug adverse reactions in a cardiac care unit (CCU). All patients admitted to CCU during a 16 months period were recruited into this study. Detection of adverse drug reactions (ADRs) was based on daily chart review and face to face interview with patients. Causality assessment was performed by the World Health Organization (WHO) probability criteria. Seriousness of ADRs was determined by WHO definition. Schumock and Thornton scale was applied to assess preventability of ADRs. Statistical analysis was performed. Among 740 cardiovascular patients admitted to CCU, 70 ADRs were recorded from 44 patients. Headache (15.71%) was the most frequent ADR. The highest ADR rates were attributed to digoxin (44.29%) and atenolol (12.86%). Fifty five (78.57%) of ADRs were serious. The rate of preventable ADRs was 62.86%. Regarding outcome, one (1.43%) ADR led to death. Multivariate logistic regression showed that length of CCU stay (OR = 1.09, 95%CI = 1.02-1.17) and non-ischemic heart diseases (OR = 3.26, 95% CI = 1.57-6.78) were risk factors for ADR occurrence. Cardiovascular drugs could develop fatal adverse reactions in CCU patients. Primary admission diagnosis and duration of CCU stay were risk factors for ADR development.

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“…According to the latest technical norms, published in October of 2009, the treatment recommended for all new cases of pulmonary and extrapulmonary tuberculosis, as well as for all cases of recurrence and retreatment due to noncompliance, is the use of a fixed-dose, single-tablet combination Adverse reactions that are more severe contribute to changes in the therapeutic regimen and lead to the use of drugs that are less active and occasionally more toxic, (8,9) substantially increasing treatment costs, as well as the number of home visits, outpatient visits, and hospitalizations. (10) These reactions can lead patients to interrupt or abandon treatment, (11) resulting in higher rates of treatment failure and acquired resistance, as well as an increase in the number of tuberculosis cases (12) and, more rarely, in the number of deaths.…”

Section: Introductionmentioning

confidence: 99%

Drogas antituberculose: interações medicamentosas, efeitos adversos e utilização em situações especiais - parte 1: fármacos de primeira linha

et al. 2010

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The main objectives of tuberculosis therapy are to cure the patients and to minimize the possibility of transmission of the bacillus to healthy subjects. Adverse effects of antituberculosis drugs or drug interactions (among antituberculosis drugs or between antituberculosis drugs and other drugs) can make it necessary to modify or discontinue treatment. We briefly review the new guidelines for the pharmacological treatment of tuberculosis, introduced by the Brazilian National Ministry of Health in 2009, and describe the general mechanism of action, absorption, metabolization, and excretion of the first-line drugs used in the basic regimen. We describe adverse drug reactions and interactions (with other drugs, food, and antacids), as well as the most appropriate approach to special situations, such as pregnancy, breastfeeding, liver failure, and kidney failure. We also describe the mechanisms by which the interactions among the antituberculosis drugs used in the basic regimen can cause druginduced hepatitis, and we discuss the alternatives in this situation.Keywords: Tuberculosis; Drug interactions; Antibiotics, antitubercular; Pharmacologic actions; Drug toxicity; Drug-induced liver injury. ResumoOs objetivos principais do tratamento da tuberculose são curar o paciente e minimizar a possibilidade de transmissão do bacilo para indivíduos saudáveis. Reações adversas ou interações das drogas antituberculose entre si e com outros fármacos podem causar modificação ou descontinuação da terapêutica. Revisamos sucintamente o novo tratamento farmacológico da tuberculose introduzido pelo Ministério da Saúde do Brasil em 2009 e mostramos os mecanismos gerais de ação, absorção, metabolização e excreção dos medicamentos utilizados no esquema básico. Descrevemos as reações adversas e as interações (com medicamentos, alimentos e antiácidos) assim como a abordagem mais adequada para situações especiais, como gravidez, amamentação, insuficiência hepática e renal. Também descrevemos os mecanismos pelos quais as interações das drogas antituberculose do esquema básico podem causar hepatite medicamentosa e as possíveis alternativas nessa situação.Descritores: Tuberculose; Interações de medicamentos; Antibióticos antituberculose; Ações farmacológicas; Toxicidade de drogas; Doença hepática induzida por drogas.

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Adverse reactions of anti‐tuberculosis drugs in hospitalized patients: incidence, severity and risk factors

Abstract: Anti-TB drugs could cause severe and frequent adverse effects. Females, those with a previous history of ADRs to anti-TB drugs and Afghani patients, should be considered as high-risk groups.

Cited by 43 publications

References 9 publications

Drug-Associated Adverse Events and Their Relationship with Outcomes in Patients Receiving Treatment for Extensively Drug-Resistant Tuberculosis in South Africa

Drug-Associated Adverse Events and Their Relationship with Outcomes in Patients Receiving Treatment for Extensively Drug-Resistant Tuberculosis in South Africa

Cardiovascular drug adverse reactions in hospitalized patients in cardiac care unit

Drogas antituberculose: interações medicamentosas, efeitos adversos e utilização em situações especiais - parte 1: fármacos de primeira linha

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