Differences in detected safety signals between benzodiazepines and non-benzodiazepine hypnotics: pharmacovigilance study using a spontaneous reporting system

Toyoshima, Manabu; Noguchi, Yoshihiro; Otsubo, Manami; Tachi, Tomoya; Teramachi, Hitomi

doi:10.7150/ijms.51658

Cited by 9 publications

(10 citation statements)

References 26 publications

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“…They cause side effects such as movement and memory disorders, as well as dizziness, lethargy and apnoea (Relative) contraindications include sleep apnoea, pulmonary disease, liver disease and temazepam is not to be used during pregnancy. Furthermore, when used for a longer period of time, benzodiazepine use is associated with dependency, tolerance and withdrawal ( Toyoshima et al, 2021 ). Hypotension, somnolence, headaches and blurred vision are common adverse effects especially associated with temazepam use ( Madari et al, 2021 ).…”

Section: Preventive Strategiesmentioning

confidence: 99%

“…Other (relative) contraindications include obstructive sleep apnoea, myasthenia gravis, severe liver disease and respiratory depression. Furthermore, the use of Z-drugs is more often associated with the occurrence of psychiatric symptoms and cortical dysfunction ( Toyoshima et al, 2021 ).…”

Section: Preventive Strategiesmentioning

confidence: 99%

“…Other less common side effects include abdominal pain, nausea, dizziness, drowsiness, amnesia, eye pain and allergic reactions. Like the other Z-drugs, its use is also associated with the occurrence of complex sleep behaviours, psychiatric symptoms and cortical dysfunction ( Toyoshima et al, 2021 ; Relative) contraindications include obstructive sleep apnoea, myasthenia gravis, severe liver or renal disease and respiratory insufficiency.…”

Section: Preventive Strategiesmentioning

confidence: 99%

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Fatigue in Aviation: Safety Risks, Preventive Strategies and Pharmacological Interventions

Wingelaar-Jagt

Wingelaar²,

Riedel

et al. 2021

Front. Physiol.

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Fatigue poses an important safety risk to civil and military aviation. In addition to decreasing performance in-flight (chronic) fatigue has negative long-term health effects. Possible causes of fatigue include sleep loss, extended time awake, circadian phase irregularities and work load. Despite regulations limiting flight time and enabling optimal rostering, fatigue cannot be prevented completely. Especially in military operations, where limits may be extended due to operational necessities, it is impossible to rely solely on regulations to prevent fatigue. Fatigue management, consisting of preventive strategies and operational countermeasures, such as pre-flight naps and pharmaceuticals that either promote adequate sleep (hypnotics or chronobiotics) or enhance performance (stimulants), may be required to mitigate fatigue in challenging (military) aviation operations. This review describes the pathophysiology, epidemiology and effects of fatigue and its impact on aviation, as well as several aspects of fatigue management and recommendations for future research in this field.

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Section: Preventive Strategiesmentioning

confidence: 99%

Section: Preventive Strategiesmentioning

confidence: 99%

Section: Preventive Strategiesmentioning

confidence: 99%

See 1 more Smart Citation

Fatigue in Aviation: Safety Risks, Preventive Strategies and Pharmacological Interventions

Wingelaar-Jagt

Wingelaar²,

Riedel

et al. 2021

Front. Physiol.

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“…The signal of drug-drug interactions detected using ROR has been recently reported in Japan as "the lower limit of the 95% CI of the ROR score when drug D 1 and drug D 2 are used together (ROR 025 drug D1 ∩ drug D2 ) > 1" and "when drug D 1 and drug D 2 are used together (ROR drug D1 ∩ drug D2 ) is greater than either the ROR score of drug D 1 (ROR drug D1 ) or the ROR score of drug D 2 (ROR drug D2 ), whichever is greater (Model 1)." The ROR score ratio (Model 1) is calculated using Equation (9). ROR score ratio (Model…”

Section: Ror =mentioning

confidence: 99%

“…However, the databases used in spontaneous reporting systems contain only cases of adverse events caused by the use of drugs and do not include the number of users of the drugs; therefore, the incidence of adverse events cannot be calculated. Thus, instead of incidence, the disproportionality analysis signals have been used to search for unknown adverse events [7][8][9]. The disproportionality analysis focuses on differences in the proportion of adverse event reports.…”

Section: Introductionmentioning

confidence: 99%

Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions

et al. 2021

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The reporting odds ratio (ROR) is easy to calculate, and there have been several examples of its use because of its potential to speed up the detection of drug–drug interaction signals by using the “upward variation of ROR score.” However, since the validity of the detection method is unknown, this study followed previous studies to investigate the detection trend. The statistics models (the Ω shrinkage measure and the “upward variation of ROR score”) were compared using the verification dataset created from the Japanese Adverse Drug Event Report database (JADER). The drugs registered as “suspect drugs” in the verification dataset were considered as the drugs to be investigated, and the target adverse event in this study was Stevens–Johnson syndrome (SJS), as in previous studies. Of 3924 pairs that reported SJS, the number of positive signals detected by the Ω shrinkage measure and the “upward variation of ROR score” (Model 1, the Susuta Model, and Model 2) was 712, 2,112, 1758, and 637, respectively. Furthermore, 1239 positive signals were detected when the Haldane–Anscombe 1/2 correction was applied to Model 2, the statistical model that showed the most conservative detection trend. This result indicated the instability of the positive signal detected in Model 2. The ROR scores based on the frequency-based statistics are easily inflated; thus, the use of the “upward variation of ROR scores” to search for drug–drug interaction signals increases the likelihood of false-positive signal detection. Consequently, the active use of the “upward variation of ROR scores” is not recommended, despite the existence of the Ω shrinkage measure, which shows a conservative detection trend.

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Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems

Noguchi,

Yoshimura

2024

Drug Saf

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Differences in detected safety signals between benzodiazepines and non-benzodiazepine hypnotics: pharmacovigilance study using a spontaneous reporting system

Cited by 9 publications

References 26 publications

Fatigue in Aviation: Safety Risks, Preventive Strategies and Pharmacological Interventions

Fatigue in Aviation: Safety Risks, Preventive Strategies and Pharmacological Interventions

Verification of the “Upward Variation in the Reporting Odds Ratio Scores” to Detect the Signals of Drug–Drug Interactions

Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems

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