1. Identifying drugs that cause acute thrombocytopenia: an analysis using 3 distinct methods.
- Author
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Reese JA, Li X, Hauben M, Aster RH, Bougie DW, Curtis BR, George JN, and Vesely SK
- Subjects
- Adverse Drug Reaction Reporting Systems, Antibodies blood, Blood Platelets immunology, Data Mining, Humans, Methods, Pharmaceutical Preparations blood, Thrombocytopenia immunology, United States, United States Food and Drug Administration, Drug-Related Side Effects and Adverse Reactions, Thrombocytopenia chemically induced, Thrombocytopenia diagnosis
- 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.
- Published
- 2010
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