Identifying drugs that cause acute thrombocytopenia: an analysis using 3 distinct methods.
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.
Department of Biostatistics and Epidemiology, College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA.
Jessica A
JA
Reese
Xiaoning
X
Li
Manfred
M
Hauben
Richard H
RH
Aster
Daniel W
DW
Bougie
Brian R
BR
Curtis
James N
JN
George
Sara K
SK
Vesely
D016907:Adverse Drug Reaction Reporting Systems; D000906:Antibodies / Q000097:blood; D001792:Blood Platelets / Q000276:immunology; D057225:Data Mining; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008722:Methods; D004364:Pharmaceutical Preparations / Q000097:blood; D013921:Thrombocytopenia / Q000139:chemically induced* / Q000175:diagnosis* / Q000276:immunology; D014481:United States; D014486:United States Food and Drug Administration
D000906:Antibodies; D004364:Pharmaceutical Preparations