AI Article Synopsis
- Tyrosine kinase inhibitors (TKIs) are commonly used to treat gastrointestinal stromal tumors (GISTs), and this study examined the neuropsychiatric adverse drug reactions (ADRs) associated with these medications using data up to December 2021.
- Out of 8,512 individual case safety reports (ICSRs) analyzed, 17.8% reported neuropsychiatric ADRs, with avapritinib (AVA) showing a significantly higher probability of such reactions.
- Unique ADRs, particularly involving spinal and olfactory nerve disorders and hallucinations, were identified for AVA, highlighting the need for further research to better understand these safety concerns in newly approved TKIs.
Article Abstract
Tyrosine kinase inhibitors (TKIs) are widely used in gastrointestinal stromal tumors (GISTs). The aim of this study is to evaluate the reporting frequency of neuropsychiatric adverse drug reactions (ADRs) for TKIs through the analysis of European individual case safety reports (ICSRs). All ICSRs collected in EudraVigilance up to 31 December 2021 with one TKI having GISTs as an indication (imatinib (IM), sunitinib (SU), avapritinib (AVA), regorafenib (REG), and ripretinib (RIP)) were included. A disproportionality analysis was performed to assess the frequency of reporting for each TKI compared to all other TKIs. The number of analyzed ICSRs was 8512, of which 57.9% were related to IM. Neuropsychiatric ADRs were reported at least once in 1511 ICSRs (17.8%). A higher reporting probability of neuropsychiatric ADRs was shown for AVA. Most neuropsychiatric ADRs were known, except for a higher frequency of lumbar spinal cord and nerve root disorders (reporting odds ratio, ROR 4.46; confidence interval, CI 95% 1.58-12.54), olfactory nerve disorders (8.02; 2.44-26.33), and hallucinations (22.96; 8.45-62.36) for AVA. The analyses of European ICSRs largely confirmed the safety profiles of TKIs in GISTs, but some ADRs are worthy of discussion. Further studies are needed to increase the knowledge of the neuropsychiatric disorders of newly approved TKIs.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10046586 | PMC |
| http://dx.doi.org/10.3390/cancers15061851 | DOI Listing |
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