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Cited by 53Platelet Disorders and TreatmentsPharmacovigilance and Adverse Drug ReactionsHeparin-Induced Thrombocytopenia and Thrombosis

Association between Drug and Vaccine Use and Acute Immune Thrombocytopenia in Childhood: A Case-Control Study in Italy

Bertuola, Federica, Morando, Carla, Menniti-Ippolito, Francesca, Da Cas, Roberto, Capuano, Annalisa, Perilongo, Giorgio, Da Dalt, Liviana·2010·Drug Safety
DOI 10.2165/11530350-000000000-00000
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Abstract

Immune thrombocytopenic purpura (ITP) is an immunomediated disease characterized by a decrease in platelet count and, in its more severe forms, by bleeding symptoms. Many drugs have been implicated in the pathogenesis of drug-induced thrombocytopenia in adults; only limited data on drug-related ITP in children have been published. Our study was set up to evaluate the consistency of the association between drug and vaccine use and ITP in children. This study is part of an Italian multicentre study on adverse drug reactions in children, coordinated by the Italian National Institute of Health, which was started in November 1999 and is ongoing. The study was conducted by enrolling all children aged more than 1 month who were hospitalized through the paediatric emergency department for the following conditions: thrombocytopenia (platelet count <100 x 103/L); acute neurological disorders; non-infectious mucocutaneous diseases and vasculitis; and endoscopically confirmed gastroduodenal lesions and/or clinically defined haematemesis and melaena. Children with chronic pathologies or concomitant diagnoses of cancer or immunodeficiency were not included in our study. During hospital admission, a physician interviewed parents using a structured questionnaire. The main aim of the interview was to collect information on drug exposure in a time period of 3 weeks and vaccine exposure in a period of 6 weeks preceding hospitalization. Using a case-control study design, exposure of children with thrombocytopenia (cases) to drugs and vaccines was compared with similar exposure of children with gastroduodenal lesions and neurological disorders (controls); this allowed us to estimate the odds ratios (ORs) of the occurrence of thrombocytopenia associated with the use of drugs or vaccines. Up to December 2007, the study population included 387 cases of thrombocytopenia and 1924 controls. Despite the low platelet count, ITP was generally a mild disease, without serious bleeding in the majority of cases and associated with a short length of hospital stay. After adjusting for concurrent use of other drugs, use of the antibacterials was associated with a more than 2-fold increase in the risk of developing ITP (OR 2.4; 95% CI 1.8, 3.1). Mucolytics and NSAIDs were associated with an OR of 1.9; 95% CI 1.2, 2.9 and 1.5; 95% CI 1.0, 2.1 respectively, while paracetamol (acetaminophen) was associated with an OR of 1.5; 95% CI 1.2, 2.0. MMR vaccination was associated with an increased risk of developing ITP (OR 2.4; 95% CI 1.2, 4.7). The results of this study provide evidence for an association between ITP and exposure to selected antibacterials, NSAIDs, paracetamol, mucolytics and MMR vaccination.

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Crossref · 10.2165/11530350-000000000-00000

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  • In Bertuola 2010, ascertainment of exposure was performed only with questionnaires to parents.

    “Ascertainment of exposure was performed only with questionnaires to parents.”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Bertuola 2010

  • In Bertuola 2010, investigators were probably not blinded to the case or control status of the participants.

    “Investigators were probably not blinded to the case or control status of the participants.”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Bertuola 2010

  • In Bertuola 2010, cases and controls were apparently not matched.

    “In Bertuola 2010, cases and controls were apparently not matched.”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Bertuola 2010

  • In Ahlgren 2009b and Bertuola 2010, the risk of bias was high.

    “High risk of bias: two studies (Ahlgren 2009b; Bertuola 2010).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Bertuola 2010

  • In Bertuola 2010, 14 of 387 cases and 27 of 1924 controls received the MMR vaccine within six weeks before hospitalisation (OR 2.4; 95% CI 1.2 to 4.7, adjusted for age and use of drugs).

    “Fourteen out of the 387 cases and 27 out of the 1924 controls received the MMR vaccine within six weeks before hospitalisation (OR 2.4; 95% CI 1.2 to 4.7, adjusted for age and use of drugs by multiple logistic regression).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Bertuola 2010

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Authors
Bertuola, F., Morando, C., Menniti-Ippolito, F., Da Cas, R., Capuano, A., Perilongo, G., & Da Dalt, L.
Affiliations
  • University of Padua (IT)
  • University of Campania "Luigi Vanvitelli" (IT)
ORCID
Venue
Drug Safety
Publisher
Springer Science and Business Media LLC
Published
2010-01
Volume
33
Issue
1
Pages
65-72
ISSN
0114-5916 (ISSN-L)
DOI
10.2165/11530350-000000000-00000
OpenAlex
W2056389418
Cited by
53
References
26
Citations by year
2026: 1 · 2024: 2 · 2023: 1 · 2022: 4 · 2021: 4 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 3 · 2016: 2 · 2015: 5 · 2014: 8 · 2013: 6 · 2012: 4
FWCI
2.67
Type
journal article
Language
en
Open access
closed
Locations
  • Drug Safety (publishedVersion)
  • PubMed (publishedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion)
Topics
  • Health Sciences › Medicine › Hematology › Platelet Disorders and Treatments
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Surgery › Heparin-Induced Thrombocytopenia and Thrombosis
Keywords
idiopathic thrombocytopenic purpura, drug-induced thrombocytopenia, vaccine adverse events, adverse drug reactions in children, antibacterial agents, mucolytic agents, nonsteroidal anti-inflammatory drugs, platelet count, gastroduodenal lesions, neurological disorders, mucocutaneous disease, vasculitis, hospitalization, case-control study
MeSH terms
Acetaminophen, Acute Disease, Adolescent, Anti-Inflammatory Agents, Non-Steroidal, Anti-Bacterial Agents, Child, Child, Preschool, Expectorants, Female, Humans, Infant, Italy, Male, Platelet Count, Odds Ratio, Case-Control Studies, Purpura, Thrombocytopenic, Idiopathic, Adverse Drug Reaction Reporting Systems, Measles-Mumps-Rubella Vaccine, Drug-Related Side Effects and Adverse Reactions

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