Abstract
Dexmedetomidine (DEX), as a widely used medication for sedation, its usage has increased significantly. The concerns about its side effects remain, making a thorough safety evaluation necessary. Data on adverse drug events related to DEX from the first quarter of 2004 to the fourth quarter of 2023 were collected from the US Food and Drug Administration. Signal quantification techniques were used for the analysis, including reporting odds ratios (RORs), proportional reporting ratios, Bayesian confidence propagation neural network and empirical Bayes geometric mean. An analysis of 20,629,811 adverse event (AE) reports identified 1977 cases of DEX-related AEs, covering 24 system organ classes and 344 preferred terms (PTs). The most common PTs were bradycardia (n = 263), cardiac arrest (n = 150), and hypotension (n = 141). Based on the ROR algorithm, the top three were: transcranial electrical motor evoked potential monitoring abnorma, acute motor axonal neuropathy, and trigemino-cardiac reflex. In addition, this study identified the adverse effects such as diabetes insipidus, coronary arteriospasm, and intestinal pseudo-obstruction, which were not previously mentioned in the instructions. It is essential to monitor, identify, and address these adverse reactions effectively.
Keywords: Dexmedetomidine, Food and Drug Administration Adverse Events Reporting System, pharmacovigilance, real-world data analysis
Introduction
Dexmedetomidine (DEX) is a highly selective α2 adrenergic receptor that was first approved for sedation and analgesia in the adult intensive care by the US Food and Drug Administration (FDA) in 1999. Recently, clinical studies have shown that DEX plays a significant role in anesthesia, sedation, intensive care, and organ function protection.[1,2] However, with the growing use of DEX and the expansion of its indications, many questions about its additional clinical effects remain. These include the risk of hypotension, hypertension, and bradycardia during DEX sedation.[1,3,4] Moreover, clinical trials conducted in the various settings cannot be directly compared with one another and do not necessarily reflect the adverse reactions seen in actual clinical practice. Therefore, a comprehensive evaluation of DEX’s safety is necessary.
In this data analysis, we used real-world pharmacovigilance data, primarily from the US FDA Adverse Event Reporting System (FAERS), to examine the adverse events (AEs) associated with DEX administration. We aim to illustrate the safety profile of DEX, identify the potential risk factors, and provide valuable insights for clinicians to optimize the patient care strategies.
Materials and Methods
Data extraction and analysis
To assess the postmarket safety of DEX, data were extracted from the American Standard Code for Information Interchange reporting files in the FAERS database, spanning from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. The FAERS data files consist of seven databases, including demographic and administrative information (DEMO), adverse drug reaction information (REAC), patient outcome information (OUTC), drug information (DRUG), drug therapy starts and end dates (THER), information on report sources (RPSR), and indications for use/diagnosis (INDI). According to the FDA guidelines, duplicate reports were removed. We selected the latest FDA_DT for the same CASEID or chose the higher PRIMARYID in cases where both the CASE number and FDA_DT were identical.
AEs associated with DEX were extracted from the REAC dataset. Preferred terms (PTs) with reporting counts of ≥3 were selected. All PTs in the REAC dataset were classified into the corresponding primary system organ class (SOC) according to the standardized Medical Dictionary for Regulatory Activities (MedDRA) version 26. Only AEs where DEX was identified as the primary suspected (PS) drug were included in the analysis [Supplementary Figure 1 (980.3KB, tif) ].
Statistical analysis
Disproportionality analysis was considered a pivotal tool for evaluating potential associations between specific AEs and particular drugs. Four statistical procedures were applied: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and Multi-item Gamma Poisson Shrinker-based empirical Bayesian geometric mean (EBGM). Specific formulas and thresholds are outlined in Supplementary Table 1. Statistical analysis was conducted using R software (version 4.4.1; R Foundation for Statistical Computing, Vienna, Austria).
Supplementary Table 1.
Four statistical procedures used for the signal detection
| Algorithms | Equation | Criteria |
|---|---|---|
| ROR | ROR=ad/b/c | lower limit of 95% CI >1, n ≥1 |
| 95% CI=eln (ROR)±1.96 (1/a+1/b+1/c+1/d)^0.5 | ||
| PRR | PRR=a (c+d)/c/(a+b) | PRR ≥ RR χ2 ≥ RR n ≥ R |
| χ2=[(ad-bc)2](a+b+c+d)/[(a+b)(c+d)(a+c)(b+d)] | ||
| BCPNN | IC=log2a (a+b+c+d)(a+c)(a+b) | IC025 >0 |
| 95% CI=E (IC)±2V (IC)0.5 | ||
| MGPS | EBGM=a (a+b + c+d)/(a+c)/(a+b) | EBGM05 >2 |
| 95%CI=eln (EBGM)±1.96 (1/a+1/b+1/c+1/d)^0.5 |
Equation: a=Number of reports containing both the target drug and target adverse drug reaction, b=Number of reports containing other adverse drug reaction of the target drug, c=Number of reports containing the target adverse drug reaction of other drugs, d=Number of reports containing other drugs and other adverse drug reactions, 95% CI=95% confidence interval, n=The number of reports, χ2=Chi-squared, IC, IC025=The lower limit of 95% CI of the IC, E (IC)=the IC expectations, V (IC)=The variance of IC, EBGM05, the lower limit of 95% CI of EBGM, EBGM=Empirical Bayesian geometric mean, IC=Information component, CI=Confidence interval, ROR=Reporting odds ratio, EBGM=Empirical Bayes geometric mean, PRR=Proportional reporting ratio, BCPNN=Bayesian confidence propagation neural network, MGPS=Multi-item Gamma Poisson Shrinker
Results
Descriptive results
From the first quarter of 2004 to the fourth quarter of 2023, a total of 20,629,811 AEs were reported in the FAERS database. Among these, 1977 AE reports identified DEX as the PS drug. Interestingly, the reported incidents have shown an increasing trend year by year [Supplementary Figure 2 (358.1KB, tif) ]. Notably, the majority of reports were submitted by medical professionals, including physicians (29.8%), hospital personnel (28.3%), other health professionals (22.9%), and pharmacists (14%). Consumer reports accounted for 2.5% of the total. Geographically, the United States contributed the highest percentage of reports at 43.3%, followed by various international representatives. Indications for DEX were mainly associated with sedation (28.3%) and sedation therapy (22.9%). Details are found in Table 1.
Table 1.
Clinical characteristics of reports with dexmedetomidine from the food and drug administration adverse events reporting system database (January 2004–December 2023)
| Characteristics | Case number, n | Case proportion (%) |
|---|---|---|
| Number of events | 1977 | |
| Sex | ||
| Female | 561 | 28.4 |
| Male | 971 | 49.1 |
| Not reported | 445 | 22.5 |
| Age (years) | ||
| <18 | 300 | 15.2 |
| 18–65 | 640 | 32.4 |
| 65–85 | 368 | 18.6 |
| >85 | 19 | 1 |
| Not reported | 650 | 32.9 |
| Weight (kg) | ||
| <50 | 209 | 10.6 |
| 50–100 | 337 | 17 |
| >100 | 73 | 3.7 |
| Not reported | 1358 | 68.7 |
| Reported countries (top six) | ||
| USA | 857 | 43.3 |
| JP | 383 | 19.4 |
| CA | 59 | 3 |
| JAPAN | 57 | 2.9 |
| FR | 48 | 2.4 |
| DE | 48 | 2.4 |
| Reporter | ||
| Physician | 589 | 29.8 |
| Hospital personnel | 559 | 28.3 |
| Other health professional | 452 | 22.9 |
| Pharmacist | 276 | 14 |
| Not reported | 51 | 2.6 |
| Consumer | 49 | 2.5 |
| RN | 1 | 0.1 |
| Indications (top five) | ||
| Sedation | 560 | 28.3 |
| Sedative therapy | 453 | 22.9 |
| Agitation | 67 | 3.4 |
| Delirium | 49 | 2.5 |
| Anesthesia | 42 | 2.1 |
Dexmedetomidine signal mining
In this study, we found that AEs related to DEX involved 24 SOCs. Cardiac disorders (n = 1019, ROR 8.69 [8.12–9.31], PRR 7.22 [5603.18], IC025 2.85 [1.18], EBGM05 7.21 [6.81]) and endocrine disorders (n = 104, ROR 7.89 [6.5–9.58], PRR 7.75 [612.81], IC025 2.95 [1.29], EBGM05 7.75 [6.59]) showed the strongest signal strength. Details are found in Table 2.
Table 2.
The signal strength of adverse events of dexmedetomidine ranked by reporting odds ratio at the system organ class level in food and drug administration adverse events reporting system database
| SOC | Case reports | ROR (95% CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|
| Cardiac disorders | 1019 | 8.69 (8.12–9.31) | 7.22 (5603.18) | 2.85 (1.18) | 7.21 (6.81) |
| Endocrine disorders | 104 | 7.89 (6.5–9.58) | 7.75 (612.81) | 2.95 (1.29) | 7.75 (6.59) |
| Vascular disorders | 293 | 2.65 (2.36–2.98) | 2.56 (284.87) | 1.36 (–0.31) | 2.56 (2.32) |
| Respiratory, thoracic, and mediastinal disorders | 463 | 1.93 (1.76–2.12) | 1.85 (189.84) | 0.89 (–0.78) | 1.85 (1.71) |
| Injury, poisoning, and procedural complications | 787 | 1.55 (1.43–1.67) | 1.46 (128.96) | 0.55 (–1.12) | 1.46 (1.37) |
| Investigations | 464 | 1.45 (1.32–1.59) | 1.41 (58.5) | 0.49 (–1.17) | 1.41 (1.3) |
| Congenital, familial, and genetic disorders | 20 | 1.19 (0.77–1.85) | 1.19 (0.61) | 0.25 (–1.42) | 1.19 (0.82) |
| Pregnancy, puerperium, and perinatal conditions | 27 | 1.17 (0.8–1.71) | 1.17 (0.65) | 0.22 (–1.44) | 1.17 (0.85) |
| Nervous system disorders | 470 | 1.04 (0.94–1.14) | 1.04 (0.61) | 0.05 (–1.62) | 1.04 (0.96) |
| Renal and urinary disorders | 104 | 1.01 (0.84–1.23) | 1.01 (0.02) | 0.02 (–1.65) | 1.01 (0.86) |
| Immune system disorders | 55 | 0.94 (0.72–1.23) | 0.94 (0.2) | –0.09 (–1.75) | 0.94 (0.75) |
| Metabolism and nutrition disorders | 90 | 0.78 (0.63–0.95) | 0.78 (5.76) | –0.36 (–2.03) | 0.78 (0.65) |
| General disorders and administration site conditions | 678 | 0.69 (0.64–0.75) | 0.73 (80.64) | –0.45 (–2.12) | 0.73 (0.68) |
| Psychiatric disorders | 200 | 0.65 (0.56–0.74) | 0.66 (37.23) | –0.6 (–2.27) | 0.66 (0.59) |
| Product issues | 43 | 0.51 (0.38–0.69) | 0.52 (19.63) | –0.95 (–2.62) | 0.52 (0.4) |
| Hepatobiliary disorders | 25 | 0.51 (0.35–0.76) | 0.52 (11.47) | –0.96 (–2.62) | 0.52 (0.37) |
| Infections and infestations | 98 | 0.34 (0.28–0.42) | 0.35 (122.88) | –1.5 (–3.17) | 0.35 (0.3) |
| Gastrointestinal disorders | 154 | 0.32 (0.27–0.38) | 0.34 (215.63) | –1.56 (–3.22) | 0.34 (0.3) |
| Surgical and medical procedures | 22 | 0.31 (0.21–0.48) | 0.32 (33.11) | –1.66 (–3.33) | 0.32 (0.22) |
| Skin and subcutaneous tissue disorders | 89 | 0.3 (0.24–0.37) | 0.31 (142.64) | –1.68 (–3.35) | 0.31 (0.26) |
| Eye disorders | 27 | 0.25 (0.17–0.37) | 0.26 (58.91) | –1.96 (–3.62) | 0.26 (0.19) |
| Musculoskeletal and connective tissue disorders | 55 | 0.19 (0.14–0.25) | 0.2 (189.78) | –2.34 (–4.01) | 0.2 (0.16) |
| Blood and lymphatic system disorders | 11 | 0.12 (0.07–0.22) | 0.12 (70.1) | –3.03 (–4.69) | 0.12 (0.07) |
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps) | 14 | 0.1 (0.06–0.16) | 0.1 (119.03) | –3.35 (–5.01) | 0.1 (0.06) |
CI=Confidence interval, ROR=Reporting odds ratio, EBGM=Empirical Bayes geometric mean, SOC=System organ class, PRR=Proportional reporting ratio
We identified a total of 344 AE signals. The most common PTs were bradycardia (n = 263), cardiac arrest (n = 150), and hypotension (n = 141) [Supplementary Table 2 (170.6KB, pdf) ]. Ranking by the ROR algorithm, the top 30 PTs are shown in Table 3. The top three were transcranial electrical motor-evoked potential monitoring abnormal (n = 5, ROR 2728.29 [1012.56–7351.24]), acute motor axonal neuropathy (n = 10, ROR 1512.48 [776.8–2944.89]), and trigemino-cardiac reflex (TCR) (n = 7, ROR 1206.64 [550.13–2646.63]). Furthermore, our study uncovered adverse effects such as diabetes insipidus (n = 100, ROR 501.78 [409.72–614.52], PRR 492.35 [46694.6], IC025 8.87 [7.21], EBGM05 468.88 [395.74]), coronary arteriospasm (n = 79, ROR 251.07 [200.5–314.39], PRR 247.35 [18907.58], IC025 7.91 [6.25], EBGM05 241.29 [199.9]), and intestinal pseudo-obstruction (n = 29, ROR 340.62 [235–493.71], PRR 338.77 [9440.61], IC025 8.36 [6.69], and EBGM05 327.5 [240.06]), which were both frequent and exhibited high signal strength and were not previously mentioned in the instructions.
Table 3.
The top 30 signal strength of adverse events of dexmedetomidine ranked by reporting odds ratio at the preferred terms level in food and drug administration adverse events reporting system database
| SOC | PTs | Case reports | ROR (95% CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|
| Injury, poisoning, and procedural complications | Floppy iris syndrome | 21 | 623.14 (400.58–969.34) | 620.68 (12,219.42) | 9.19 (7.52) | 583.81 (403.38) |
| Injury, poisoning, and procedural complications | Recurrence of neuromuscular blockade | 5 | 361.1 (147.86–881.88) | 360.76 (1730.2) | 8.44 (6.76) | 348 (164.86) |
| Injury, poisoning, and procedural complications | Airway complication of anesthesia | 7 | 325.96 (153.44–692.47) | 325.54 (2192.07) | 8.3 (6.62) | 315.12 (167.75) |
| Injury, poisoning, and procedural complications | Mechanical ventilation complication | 3 | 283.22 (89.84–892.77) | 283.06 (819.54) | 8.1 (6.41) | 275.15 (105.28) |
| Injury, poisoning, and procedural complications | Sedation complication | 30 | 154.51 (107.62–221.83) | 153.64 (4479.49) | 7.24 (5.57) | 151.29 (111.79) |
| Injury, poisoning, and procedural complications | Delayed recovery from anesthesia | 11 | 138.49 (76.33–251.27) | 138.21 (1477.55) | 7.09 (5.42) | 136.3 (82.8) |
| Cardiac disorders | Cardiac arrest neonatal | 4 | 338.62 (124.93–917.81) | 338.37 (1300.63) | 8.35 (6.67) | 327.12 (142.03) |
| Cardiac disorders | Arteriospasm coronary | 79 | 251.07 (200.5–314.39) | 247.35 (18,907.58) | 7.91 (6.25) | 241.29 (199.9) |
| Cardiac disorders | Sinus arrest | 31 | 237.55 (166.19–339.56) | 236.17 (7089.06) | 7.85 (6.18) | 230.65 (171.05) |
| Cardiac disorders | Rhythm idioventricular | 4 | 149.35 (55.62–401.06) | 149.24 (580.17) | 7.2 (5.52) | 147.02 (64.33) |
| Cardiac disorders | Atrioventricular dissociation | 3 | 122.73 (39.29–383.34) | 122.66 (357.53) | 6.92 (5.24) | 121.16 (46.71) |
| Nervous system disorders | Acute motor axonal neuropathy | 10 | 1512.48 (776.8–2944.89) | 1509.63 (13,066.17) | 10.35 (8.65) | 1308.48 (749.26) |
| Nervous system disorders | Trigemino-cardiac reflex | 7 | 1206.64 (550.13–2646.63) | 1205.06 (7500.32) | 10.07 (8.36) | 1073.36 (556.32) |
| Nervous system disorders | Postresuscitation encephalopathy | 3 | 490.91 (153.91–1565.75) | 490.63 (1396.09) | 8.87 (7.16) | 467.31 (177.06) |
| Nervous system disorders | Drug withdrawal convulsions | 21 | 132.87 (86.31–204.54) | 132.35 (2701.1) | 7.03 (5.36) | 130.6 (91.03) |
| Respiratory, thoracic and mediastinal disorders | Central sleep apnea syndrome | 7 | 625.26 (291.1–1343) | 624.44 (4096.41) | 9.2 (7.51) | 587.14 (309.69) |
| Respiratory, thoracic, and mediastinal disorders | Upper airway obstruction | 38 | 505.46 (364.45–701.05) | 501.86 (18,070.68) | 8.9 (7.23) | 477.49 (363.16) |
| Respiratory, thoracic, and mediastinal disorders | Hypocapnia | 6 | 167.93 (74.9–376.51) | 167.74 (977.75) | 7.37 (5.69) | 164.93 (83.93) |
| Investigations | Transcranial electrical motor-evoked potential monitoring abnormal | 5 | 2728.29 (1012.56–7351.24) | 2725.72 (10,658.06) | 11.06 (9.29) | 2133.39 (930.85) |
| Investigations | Central venous pressure increased | 3 | 272.73 (86.57–859.2) | 272.57 (789.79) | 8.05 (6.36) | 265.23 (101.54) |
| Investigations | Mean arterial pressure decreased | 5 | 239.56 (98.61–581.94) | 239.33 (1158.43) | 7.87 (6.19) | 233.66 (111.18) |
| Gastrointestinal disorders | Glossoptosis | 18 | 1001.28 (616.09–1627.3) | 997.89 (16,271.42) | 9.82 (8.14) | 905.87 (603.38) |
| Gastrointestinal disorders | Intestinal pseudo-obstruction | 29 | 340.62 (235–493.71) | 338.77 (9440.61) | 8.36 (6.69) | 327.5 (240.06) |
| Vascular disorders | Withdrawal hypertension | 7 | 393.02 (184.55–837) | 392.5 (2628.42) | 8.56 (6.88) | 377.45 (200.52) |
| Vascular disorders | Neonatal hypotension | 8 | 241.9 (119.89–488.09) | 241.54 (1870.34) | 7.88 (6.21) | 235.76 (131.04) |
| Endocrine disorders | Diabetes insipidus | 100 | 501.78 (409.72–614.52) | 492.35 (46,694.6) | 8.87 (7.21) | 468.88 (395.74) |
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps) | Phaeochromocytoma crisis | 7 | 487.79 (228.25–1042.46) | 487.15 (3235.45) | 8.86 (7.18) | 464.16 (245.86) |
| General disorders and administration site conditions | Hyperthermia malignant | 20 | 158.61 (101.88–246.91) | 158.01 (3071.01) | 7.28 (5.61) | 155.52 (107.39) |
| Product issues | Product closure removal difficult | 11 | 156.76 (86.35–284.56) | 156.43 (1672.2) | 7.27 (5.6) | 153.99 (93.5) |
| Congenital, familial, and genetic disorders | Epidermolysis bullosa | 3 | 131.49 (42.08–410.93) | 131.42 (383.15) | 7.02 (5.34) | 129.7 (49.99) |
PTs=Preferred terms, CI=Confidence interval, ROR=Reporting odds ratio, EBGM=Empirical Bayes geometric mean, SOC=System organ class, PRR=Proportional reporting ratio
Discussion
Previous studies on DEX have mostly focused on its mechanism, clinical trials, and literature analysis, with few articles concentrating on the latest real-world research. Based on the largest samples of the real-world data, we collected and evaluated the pharmacovigilance of DEX postmarket. The purpose is to analyze new and meaningful adverse reactions, guide updates to the summary of product characteristics, and provide a basis for rational clinical drug use.
Our study found that AEs associated with DEX have increased year by year in recent years, a trend consistent with its rising usage and expanding indications. Although DEX is currently approved for intravenous sedation, multiple routes of administration such as intrathecal, intranasal, oral, and subcutaneous use have been mentioned worldwide.[5,6] In addition, clinical studies have found that DEX can reduce the incidence of mortality- and surgery-related complications.[7] With the widening clinical usage of DEX, more patients are receiving treatment, resulting in a significant increase in AE reports.
Furthermore, the majority of reports came from the United States, followed by Japan, which may be related to the earlier market introduction in these countries and potential regional or cultural biases.
At the PT level, the most frequent AEs were bradycardia, cardiac arrest, and hypotension. These findings are consistent with drug instructions and clinical trials.[1,3,4] Notably, our study found that coronary arteriospasm is a cardiovascular AE related to DEX, which aligns with relevant reports.[8] DEX treatment may activate the α-2 adrenergic receptors, which mediate vasoconstriction of the coronary circulation,[9] and transient coronary spasm is likely caused by a combination of factors including surgical stress and altered autonomic function.[10] Further studies are needed to explore this relationship.
Our study shows that transcranial electrical motor-evoked potential monitoring abnormal ranks first by the ROR algorithm. There have been reports indicating that excessive DEX infusion was responsible for the deterioration in transcranial electric motor-evoked potentials during spine surgery.[11] Target plasma concentrations of 0.4 ng/mL DEX and 2.5 µg/mL propofol seem to have minimal effect on transcranial electrical motor-evoked potential amplitude. The potential risks and benefits of DEX should be assessed before spine surgery.
Compared to common AEs within the cardiovascular system, the strong association between DEX and AEs in the endocrine system, particularly diabetes insipidus is unexpected and has not received widespread attention in drug labeling. Studies performed on dogs and rats undergoing general anesthesia have shown that DEX has a diuretic-like effect associated with decreased urine osmolarity, increased free water clearance, and a reduction in plasma vasopressin levels. These studies suggest that DEX may induce both vasopressin suppression and responsiveness.[12] Although the polyuria response has not been confirmed in human studies, a growing number of case reports suggest a link between DEX and diabetes insipidus, with urine volume returning to normal within several hours to 24 h after discontinuation of DEX.[13,14]
Neurologic AEs related to DEX deserve our attention. Both intranasal and intravenous use of DEX can lead to an increased incidence of TCR during eye surgery.[15] An experimental study on rabbits showed that the lowest doses of DEX (1 and 2 µg/mL) combined with 0.25% ropivacaine for continuous femoral nerve block resulted in no neurotoxic lesions, but the higher dose (3 µg/mL) resulted in neurotoxic lesions.[16] Considering the high signals of ROR, we should pay attention to the neurological AEs of DEX.
In addition, there have been reports linking DEX to adverse gastrointestinal reactions.[17,18] In vitro studies in guinea pigs show that DEX inhibits intestinal peristalsis through the α2-adrenoreceptor agonist effects on enteric neurons.[19] Studies in humans show that DEX delayed gastric emptying and gastrointestinal transit.[20] Therefore, with the increasing use of DEX sedation in the intensive care unit, clinicians need to be aware of the DEX-mediated reduction in bowel motility and the increased risk of intestinal pseudo-obstruction.
Although this study provides strong scientific evidence for evaluating the safety of DEX from all angles, it does have certain limitations. First, spontaneous reporting to collect the data may introduce the potential biases and incomplete information, such as the sampling bias of high-reporting countries. Second, the data did not take into account comorbidities and the dosage of DEX, which cannot explain the relationship between DEX and AEs. In addition, the limitations of the database, the retrospective nature of the studies, and possible reporting biases could also affect these findings.
Conclusion
Our pharmacovigilance analysis of the real-world data from the FEARS database reveals the safety signals and potential risks of DEX use, including hypotension, and bradycardia. Unexpected AEs, such as diabetes insipidus, coronary spasm, false intestinal paralysis, trigeminal cardiac reflex, and other AEs not mentioned in the drug instructions, may also occur. Further clinical studies are needed to confirm and clarify the association of DEX with these adverse effects.
Conflicts of interest
There are no conflicts of interest.
The frequency of adverse events of dexmedetomidine at the preferred terms level in Food and Drug Administration adverse events reporting system database
The flow diagram of selecting dexmedetomidine-related adverse events from FAERS public dashboard
Frequency of dexmedetomidine-related adverse events in the FAERS public dashboard
Funding Statement
Nil.
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
The frequency of adverse events of dexmedetomidine at the preferred terms level in Food and Drug Administration adverse events reporting system database
The flow diagram of selecting dexmedetomidine-related adverse events from FAERS public dashboard
Frequency of dexmedetomidine-related adverse events in the FAERS public dashboard