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June 9, 2010Blood147 citationsOpen Access

Identifying drugs that cause acute thrombocytopenia: an analysis using 3 distinct methods

JRJessica ReeseXLXiaoning LiMHManfred Hauben

Key Points

  • To evaluate and compare three distinct approaches—published case reports, laboratory antibody testing, and pharmacovigilance data mining—for identifying medications that cause acute immune thrombocytopenia.
  • Assessed published case reports of 253 suspected drugs using defined clinical criteria to establish causality.
  • Tested patient serum samples across 202 drugs for the presence of drug-dependent, platelet-reactive antibodies.
  • Applied data mining algorithms to the FDA Adverse Event Reporting System database to evaluate 1,444 drugs with thrombocytopenia reports.
  • Evidence of drug-induced thrombocytopenia was identified for 87 of 253 drugs (34%) via case reports, 67 of 202 drugs (33%) via antibody assays, and 573 of 1,444 drugs (40%) via FAERS data mining.
  • Among 1,468 total suspected drugs, 102 were assessed by all 3 identification methods, with 23 drugs demonstrating positive evidence across all three approaches.

Abstract

Drug-induced immune thrombocytopenia (DITP) is often suspected in patients with acute thrombocytopenia unexplained by other causes, but documenting that a drug is the cause of thrombocytopenia can be challenging. To provide a resource for diagnosis of DITP and for drug safety surveillance, we analyzed 3 distinct methods for identifying drugs that may cause thrombocytopenia. (1) Published case reports of DITP have described 253 drugs suspected of causing thrombocytopenia; using defined clinical criteria, 87 (34%) were identified with evidence that the drug caused thrombocytopenia. (2) Serum samples from patients with suspected DITP were tested for 202 drugs; drug-dependent, platelet-reactive antibodies were identified for 67 drugs (33%). (3) The Food and Drug Administration's Adverse Event Reporting System database was searched for drugs associated with thrombocytopenia by use of data mining algorithms; 1444 drugs had at least 1 report associated with thrombocytopenia, and 573 (40%) drugs demonstrated a statistically distinctive reporting association with thrombocytopenia. Among 1468 drugs suspected of causing thrombocytopenia, 102 were evaluated by all 3 methods, and 23 of these 102 drugs had evidence for an association with thrombocytopenia by all 3 methods. Multiple methods, each with a distinct perspective, can contribute to the identification of drugs that can cause thrombocytopenia.

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Cite This Study

Reese et al. (2010) studied this question.

synapsesocial.com/papers/69d97d728988aeabbe685798https://doi.org/10.1182/blood-2010-03-276691
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