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Expert opinion on drug safety

ISSN 1744-764X

2 papers in the library · 9 citations · publishing 2024-2025

Papers

The association between ketamine and esketamine and suicidality: reports to the Food And Drug Administration Adverse Event Reporting System (FAERS).

Expert opinion on drug safety June 21, 2024 Roger S McIntyre, Rodrigo B Mansur, Joshua D Rosenblat et al. 7 citations

Ketamine and esketamine reduce measures of suicidality in people with treatment-resistant depression, but whether they can worsen preexisting suicidality is unclear. Analysis of the FDA Adverse Event Reporting System from 1970 and 2019 through September 2023 found higher reporting odds ratios for suicidal ideation (7.58) and depression suicidal (14.19) with esketamine compared to lithium. In contrast, lower reporting odds ratios for suicide attempt were observed with both ketamine (0.15) and esketamine (0.57). The mixed results across different aspects of suicidality prevent any determination of causal effects, and the lower odds for suicide attempt cannot be interpreted as a direct therapeutic effect.

Comparative safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database.

Expert opinion on drug safety April 24, 2025 Yingqiu Tu, Xin Lai, Qing Wan et al. 2 citations

An analysis of the FDA Adverse Event Reporting System database found that baloxavir marboxil is strongly associated with ischemic colitis, melena, febrile delirium, enterocolitis, febrile convulsion, and altered consciousness, while oseltamivir is strongly associated with pathological personality, abnormal thinking, agitation, abnormal behavior, sleepwalking, febrile delirium, and spinal cord hemorrhage. The study reviewed 1,727 adverse event reports for baloxavir marboxil and 12,607 for oseltamivir from US market approval through the third quarter of 2023. Clinicians should monitor for both common and label-unlisted adverse events when using these anti-influenza drugs.