Incidence and Risk Factors for Agranulocytosis in Latin American Countries - The LATIN Study.

Hamerschlak, Nelson; Maluf, Eliane Mara Cesário Pereira; Eluf, Jose; Cavalcante, Alexandre; Pasqüini, Ricardo; Lorand‐Metze, Irene; Falcao, R P

doi:10.1182/blood.v110.11.3842.3842

Cited by 12 publications

(23 citation statements)

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“…Agranulocytosis. Five case-control studies 15,16,20,28,33 and one casecohort study 23 • estimates did not account for dose and duration of use Safety of metamizole substantially across studies, ranging from 1Á5 (95% CI, 0Á8-2Á7) to 40Á2 (95% CI, 14Á7-113Á3) for the overall association with metamizole; one study 19 conducted in Thailand had too few cases to adequately evaluate the association with metamizole (25 overall cases; 1 case was exposed to metamizole). Associations between acetaminophen, aspirin/salicylates, diclofenac, or other NSAIDs and agranulocytosis were inconsistently found across studies, with the risks generally substantially lower for these non-narcotic agents compared to metamizole.…”

Section: Description Of Study Methods and Resultsmentioning

confidence: 99%

“…The Latin Study identified 30 cases of agranulocytosis and 120 controls in haematology clinics and hospitals in Brazil, Argentina and Mexico during 2002 to 2005. 28 Exposure to medications in the 10day period before symptom onset was identified through patient interviews. Metamizole was not associated with a significantly increased risk of agranulocytosis (OR 2Á4, 95% CI, 0Á8-6Á7).…”

Section: Description Of Study Methods and Resultsmentioning

confidence: 99%

“…Of these, eight were included in the literature review. [26][27][28][29][30][31][32][33] Thus, of the 22 qualifying studies included in this review, 12 were identified from the primary PubMed search, eight were identified through references of articles that underwent full-text review, and two were identified through the Google Scholar search. Six studies evaluated agranulocytosis; 15,16,20,23,28,33 three evaluated aplastic anaemia; [31][32][33] five evaluated upper gastrointestinal bleeding; 13,18,24,29,30 two evaluated congenital anomalies and birth outcomes associated with in utero exposure; 12,27 three evaluated childhood cancer associated with in utero exposure; 21,25,26 one evaluated hepatic effects; 19 one evaluated anaphylaxis; 15 one evaluated bleeding complications after percutaneous liver biopsy, 22 and one evaluated the severity of dengue virus infection.…”

Section: Full-text Reviewsmentioning

confidence: 99%

“…Two of the casecontrol studies also encompassed small study populations (≤30 total cases). 20,28 A limitation of most published studies was the lack of assessment of the impact of dose, duration of therapy, route of administration or previous therapy with the medications of interest. As non-constant hazards of agranulocytosis are likely over time, the relative risk estimates for most medications may be underestimated.…”

Section: Strengths and Limitations Of Published Studiesmentioning

confidence: 99%

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Safety of metamizole: a systematic review of the literature

et al. 2016

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SUMMARYWhat is known and objective: Metamizole was withdrawn from the market in the United States and several European countries following reports of fatal agranulocytosis among users, but is still available in many countries in Europe, South America and Asia. Over the past several decades, a number of epidemiologic studies have been conducted to quantify the risk of agranulocytosis and other adverse effects associated with metamizole and other non-narcotic analgesics. The objective of this study was to perform a systematic review of the safety of metamizole. Methods: Epidemiologic studies published between 1 January 1980 and 15 December 2014 were identified through systematic searches of PubMed and Google Scholar; the reference sections of selected articles were also reviewed to identify potentially relevant studies. Studies included in this review focused on the safety of metamizole, that is on outcomes such as haematologic abnormalities, gastrointestinal bleeding, anaphylaxis and hepatotoxicity. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to prespecified criteria. Results and discussion: A total of 22 articles met the criteria for evaluation. The majority of studies that evaluated agranulocytosis indicated an increased risk associated with metamizole, with relative risk (RR) estimates ranging from 1Á5 (95% CI, 0Á8-2Á7) to 40Á2 (95% CI, 14Á7-113Á3). Findings of three casecontrol studies do not suggest an association between metamizole and aplastic anaemia. Of the five case-control studies that evaluated the risk of upper gastrointestinal bleeding, four found a statistically significant increased risk associated with metamizole (RR estimates ranging from 1Á4 to 2Á7). There is insufficient evidence to determine whether metamizole increases the risk of other outcomes (e.g. hepatic effects, anaphylaxis, congenital anomalies). Few studies evaluated the effects of dose, route of administration or duration of therapy. What is new and conclusion: Published studies reported differences in the magnitude of risk of adverse outcomes associated with metamizole use and often had small sample sizes and a number of other limitations that may have biased the results. Further research is needed to better quantify the potential risks associated with metamizole compared to other non-narcotic analgesics. WHAT IS KNOWN AND OBJECTIVEMetamizole is a pyrazolone derivative that is an effective nonnarcotic analgesic and antipyretic agent.1,2 Metamizole was withdrawn from the market in the United States and several European countries following reports of fatal agranulocytosis among users, but is still available by prescription and/or over-the-counter (OTC) in many countries in Europe, South America and Asia.3 There is still considerable controversy surrounding its safety, which has led to varying levels of use and regulatory restrictions across countries.Since the 1970s when metamizole was initially banned in several countries, a number of non-interventional epidemiolo...

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Section: Description Of Study Methods and Resultsmentioning

confidence: 99%

Section: Description Of Study Methods and Resultsmentioning

confidence: 99%

Section: Full-text Reviewsmentioning

confidence: 99%

Section: Strengths and Limitations Of Published Studiesmentioning

confidence: 99%

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Safety of metamizole: a systematic review of the literature

et al. 2016

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“…The incidence is estimated to be between 2·4 and 15·4 cases per one million inhabitants. Agranulocytosis may simply be detected following a routine full blood count or it may present with the onset of frequent infections with varying degrees of severity (Ibáñez et al , 2005; Andersohn et al , 2007; Hamerschlak et al , 2008).…”

mentioning

confidence: 99%

The role of haematopoietic growth factors granulocyte colony‐stimulating factor and granulocyte‐macrophage colony‐stimulating factor in the management of drug‐induced agranulocytosis

Andrès

Maloisel²,

Zimmer

2010

Br J Haematol

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SummaryDrug-induced agranulocytosis (neutrophil count <0AE5 · 10 9 /l) is a rare haematological complication with an incidence of no more than 10 cases per million inhabitants per year in Europe.Over the past few years there has been a steady decline in mortality rate, (currently at <5%), which can be partly explained by earlier recognition and the improved clinical management of associated intercurrent infections that may lead to severe sepsis if left untreated. The true impact of the use of haematopoietic growth factors, such as granulocyte colonystimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF), on the decreased mortality rate remains unknown. Yet, most studies show that these molecules, especially G-CSF, reduce the duration of agranulocytosis, antibiotic course and length of hospital stay. Their use is particularly recommended in patients with poor prognostic factors, such as a neutrophil count <0AE1 · 10 9 /l, age over 65 years, severe infection or multiple co-morbidities. In all cases, the drug responsible for causing the agranulocytosis must be discontinued and remain permanently contraindicated. The appropriate Medicines Regulatory Agency must also be notified of the adverse event.

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Beta‐lactam‐induced severe neutropaenia: a descriptive study

Vial

Bailly

Pérault‐Pochat

et al. 2018

Fundamemntal Clinical Pharma

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The objectives of this study were to describe the characteristics and natural history of beta‐lactam‐induced severe neutropaenia and to evaluate the risk of recurrences after another beta‐lactam readministration. Reports of pure agranulocytosis associated with a beta‐lactam exposure within the 10 days preceding the neutropaenia were extracted from the French Pharmacovigilance Database over the year 2010. Cases with another evident cause or more likely attributable to another drug were excluded. Data were analyzed for demographics, clinical and biological features, prognosis factors, granulocyte colony stimulating factors administration and outcome. Sixty‐two cases were included (median age: 65 years). The median duration of treatment before neutropaenia was 16 days. In 47% of cases, the diagnosis was made on a systematic blood cell count. The median neutrophil count at nadir was 0.125 × 109/L, and bone marrow examination evidenced features of neutrophilic maturation arrest or aplasia in 21 patients, hyperplasia of granulopoietic cells in three and normal findings in five. Three patients developed severe sepsis. All but one recovered a normal blood cell count within 2–56 days after beta‐lactam discontinuation. The last patient died from recurrent severe septic shock. No significant effect of granulocyte colony stimulating factor on the mean duration of haematological recovery was found. Among the 21 patients who later received another beta‐lactam, two experienced recurrence of the neutropaenia after receiving a beta‐lactam from another subfamily. Beta‐lactam‐induced agranulocytosis was usually observed after prolonged treatment, and severe complications are uncommon. In most patients, a subsequent treatment with another beta‐lactam was well tolerated.

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Incidence and Risk Factors for Agranulocytosis in Latin American Countries - The LATIN Study.

Cited by 12 publications

References 0 publications

Safety of metamizole: a systematic review of the literature

Safety of metamizole: a systematic review of the literature

The role of haematopoietic growth factors granulocyte colony‐stimulating factor and granulocyte‐macrophage colony‐stimulating factor in the management of drug‐induced agranulocytosis

Beta‐lactam‐induced severe neutropaenia: a descriptive study

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