The Association Between Deep Vein Thrombosis, Pulmonary Embolism, and Janus Kinase Inhibitors: Reporting Status and Signal Detection in the Japanese Adverse Drug Event Report Database

• DOI: 10.1007/s40801-024-00447-w
• Publication Date: 2024-07-20T11:01:32Z
• Authors: Tae Maeshima; Sayaka Aisu; Naoki Ohkura; Machiko Watanabe; Fumio Itagaki
• Keywords: Janus kinase 2

Although Janus kinase (JAK) inhibitors have expanding indications, deep vein thrombosis (DVT) and pulmonary embolism (PE) are serious adverse events associated with their use. Moreover, analysis using the Japanese database of spontaneous drug reaction reports has not yet been conducted. The objective this study was to analyze Adverse Drug Event Report (JADER) evaluate association between JAK DVT PE. JADER from April 2004 October 2023 were analyzed. A classification for period covered performed by drug, an imbalance oral as target DVT, PE, "embolic thrombotic events, venous" (Standardised MedDRA Query; SMQ) events. Reported odds ratios (ROR) information components (IC) calculated signal detection. Overall, 6631 inhibitor-related reported, including 60 41 cases respectively. ROR IC 2.52 (1.95–3.25) 1.27 (0.41–2.13), while those baricitinib 4.37 (2.83–6.73) 1.90 (0.47–3.33), signals detected PE venous (SMQ)," overall several but none IC. Several under postmarketing phase vigilance, number reported is low. However, when administering these drugs, care should be taken avoid development thromboembolism, considering patient's background.