Identification and Characteristics of Time-Related Shifts in Suicide-Related Event Frequency During Smoking Cessation Treatment with Varenicline

Abstract

Objectives: To survey time-related shifts in number of suicide-related events (SRE) during smoking cessation treatment with varenicline (VAR) in cases from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), as well as the characteristics of these shifts.Methods: We isolated cases from the FAERS database involving VAR usage where SRE was reported as an adverse event (SRE+/VAR+ case) and established a histogram of SRE+/VAR+ case numbers per week. Furthermore, we focused on “cases reporting specific adverse events prior to drug usage start” using X-bar and R chart concepts. We also attempted to exclude the influence of smoking history from the created histogram. Moreover, we constructed a histogram on central nervous system adverse events, which were frequently seen during VAR usage.Results: By removing the effects of smoking history, SRE onset signals were detected over a long period from the start of VAR use. However, expression signals for nausea and abnormal dreams were detected only in the early VAR administration period.Discussion: These results suggest that VAR use-induced SRE is expressed over a long timeframe from the start of treatment. Additionally, the period of SRE expression signal detection was longer than that of the other central nervous system adverse events (nausea and abnormal dreams). Therefore, SRE onset must be carefully monitored during smoking cessation treatment with VAR over the entire treatment period.

Onset timing of statin‐induced musculoskeletal adverse events and concomitant drug‐associated shift in onset timing of MAEs

“…However, if musculoskeletal adverse events (MAEs) such as myalgia, myopathy, and rhabdomyolysis develop during the statin use period, these cholesterol‐lowering treatments may need to be temporarily or permanently discontinued . There are a few reports detailing the onset timing of drug‐induced adverse events . In 2004, Chang et al reported the onset timing of statin‐induced rhabdomyolysis .…”

“…To reduce and prevent the risk of adverse events in a clinical setting, it is important to acquire information on both the risk and onset timing of drug‐induced adverse events. We have already evaluated the onset timing of adverse events as well as the risk of these events . Although many drugs have the potential to cause the same adverse event, especially those within the same medication class, the onset timing of these events for individual drugs may differ; thus, it is important to evaluate the onset timing of side effects associated with each drug.…”