Dexdor Adverse Reactions

Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Use of Dexdor has been associated with the following serious adverse reactions: Hypotension, bradycardia and sinus arrest [see Hypotension, Bradycardia, and Sinus Arrest under Precautions]; Transient hypertension [see Transient Hypertension under Precautions].
Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth.
Intensive Care Unit Sedation: Adverse reaction information is derived from the continuous infusion trials of dexmedetomidine for sedation in the Intensive Care Unit setting in which 1007 adult patients received dexmedetomidine. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 10. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Hypotension, Bradycardia, and Sinus Arrest under Precautions]. (See Table 10.)

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Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of dexmedetomidine for sedation in the surgical intensive care unit setting in which 387 adult patients received dexmedetomidine for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 11).

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In a controlled clinical trial, dexmedetomidine was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 12. The number (%) of subjects who had a dose related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the dexmedetomidine group is provided in Table 13. (See Table 12.)

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The following adverse events occurred between 2 and 5% for dexmedetomidine and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%). (See Table 13.)

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In a controlled clinical trial 3005012, Dexdor was compared to propofol for continuous sedation of ventilated adult ICU patients needing light to moderate sedation (RASS 0 to -3) for more than 24 hours. Treatment emergent adverse events occurring in at least 2% of the dexmedetomidine treated patients in the study 3005012 are provided in Table 14. (See Table 14.)

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In a controlled clinical trial 3005013, Dexdor was compared to midazolam for continuous sedation of ventilated adult ICU patients needing light to moderate sedation (RASS 0 to -3) for more than 24 hours. Treatment emergent adverse events occurring in at least 2% of the dexmedetomidine treated patients in the study 3005013 are provided in Table 15. (See Table 15.)

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Procedural Sedation: Adverse reaction information is derived from the two trials for procedural sedation [see PHARMACOLOGY: CLINICAL STUDIES: Procedural Sedation under Actions] in which 318 adult patients received dexmedetomidine. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, ASA I-IV, 30% ≥65 years of age, 52% male and 61% Caucasian.
Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 16. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Hypotension, Bradycardia, and Sinus Arrest under Precautions]. Prespecified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between dexmedetomidine and comparator groups in both studies. (See Table 16.)

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Postmarketing Experience: The following adverse reactions have been identified during post approval use of Dexdor. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypotension and bradycardia were the most common adverse reactions associated with the use of Dexdor during post approval use of the drug. (See Table 17.)

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