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Precedex (Dexmedetomidine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

6.1Clinical 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 Precedex has been associated with the following serious adverse reactions:

  • Hypotension, bradycardia and sinus arrest [ see Warnings and Precautions (5.2) ]

  • Transient hypertension [ see Warnings and Precautions (5.3) ]

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 Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. 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 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [ see Warnings and Precautions (5.2) ].

Table 2: Adverse Reactions With an Incidence > 2% —Intensive Care Unit Sedation Population
Body System/

Adverse Event

All Precedex

N = 1007

Randomized

Precedex

N = 798

Placebo

N = 400

Propofol

N = 188

n (%)

n (%)

n (%)

n (%)

Vascular Disorders

Hypotension

Hypertension

248 (25%)

123 (12%)

191 (24%)

101 (13%)

48 (12%)

76 (19%)

25 (13%)

7 (4%)

Gastrointestinal Disorders

Nausea

Dry mouth

Vomiting

90 (9%)

35 (4%)

34 (3%)

73 (9%)

22 (3%)

26 (3%)

36 (9%)

4 (1%)

21 (5%)

20 (11%)

1 (1%)

6 (3%)

Cardiac Disorders

Bradycardia

Atrial fibrillation

Tachycardia

Sinus tachycardia

Ventricular tachycardia

52 (5%)

44 (4%)

20 (2%)

6 (1%)

4 (0%)

36 (5%)

37 (5%)

15 (2%)

6 (1%)

4 (1%)

10 (3%)

13 (3%)

17 (4%)

2 (1%)

3 (1%)

0

14 (7%)

2 (1%)

4 (2%)

9 (5%)

General Disorders and Administration Site Conditions

Pyrexia

Hyperthermia

Chills

Edema peripheral

35 (4%)

19 (2%)

17 (2%)

4 (0%)

31 (4%)

16 (2%)

14 (2%)

2 (0%)

15 (4%)

12 (3%)

13 (3%)

2 (1%)

8 (4%)

0

4 (2%)

4 (2%)

Metabolism and Nutrition Disorders

Hypovolemia

Hyperglycemia

Hypocalcemia

Acidosis

31 (3%)

17 (2%)

7 (1%)

6 (1%)

22 (3%)

15 (2%)

7 (1%)

5 (1%)

9 (2%)

7 (2%)

0

4 (1%)

9 (5%)

5 (3%)

4 (2%)

4 (2%)

Respiratory, Thoracic and Mediastinal Disorders

Atelectasis

Pleural effusion

Hypoxia

Pulmonary edema

Wheezing

29 (3%)

23 (2%)

16 (2%)

9 (1%)

4 (0%)

23 (3%)

16 (2%)

13 (2%)

9 (1%)

4 (1%)

13 (3%)

4 (1%)

8 (2%)

3 (1%)

1 (0%)

12 (6%)

12 (6%)

5 (3%)

5 (3%)

4 (2%)

Psychiatric Disorders

Agitation

20 (2%)

16 (2%)

11 (3%)

1 (1%)

Blood and Lymphatic System Disorders

Anemia

19 (2%)

18 (2%)

7 (2%)

4 (2%)

Injury, Poisoning and Procedural Complications

Post-procedural hemorrhage

15 (2%)

13 (2%)

10 (3%)

7 (4%)

Investigations

Urine output decreased

6 (1%)

6 (1%)

0

4 (2%)

Procedural Sedation

Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. 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, 30% ≥ 65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 3. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [ see Warnings and Precautions (5.2) ]. Pre-specified 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 Precedex and comparator groups in both studies.

Table 3: Adverse Reactions With an Incidence > 2% —Procedural Sedation Population
Body System/

Adverse Event

Precedex

N = 318

Placebo

N = 113

n (%)

n (%)

1 Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or diastolic blood pressure of <50 mmHg.

2 Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or diastolic blood pressure of >100 mmHg.

3 Bradycardia was defined in absolute and relative terms as<40 beats per minute or ≤30% lower than pre-study drug infusion value.

4 Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value.

5 Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 breaths per minute or > 25% decrease from baseline.

6 Hypoxia was defined in absolute and relative terms as SpO2 < 90% or 10% decrease from baseline.

Vascular Disorders

Hypotension1

Hypertension2

173 (54%)

41 (13%)

34 (30%)

27 (24%)

Respiratory, Thoracic and Mediastinal Disorders

Respiratory depression5

Hypoxia6

Bradypnea

117 (37%)

7 (2%)

5 (2%)

36 (32%)

3 (3%)

5 (4%)

Cardiac Disorders

Bradycardia3

Tachycardia4

45 (14%)

17 (5%)

4 (4%)

19 (17%)

Gastrointestinal Disorders

Nausea

Dry mouth

10 (3%)

8 (3%)

2 (2%)

1 (1%)

6.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of Precedex. 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 Precedex during post approval use of the drug.

Table 4: Adverse Reactions Experienced During Post-approval Use of Precedex
Body System Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia,

light anesthesia, pain, rigors

Cardiovascular Disorders,

General

Blood pressure fluctuation, heart disorder,

hypertension, hypotension, myocardial infarction

Central and

Peripheral Nervous

System Disorders

Dizziness, headache, neuralgia,

neuritis, speech disorder, convulsion

Gastrointestinal

System Disorders

Abdominal pain, diarrhea, vomiting,

nausea

Heart Rate and

Rhythm Disorders

Arrhythmia, ventricular arrhythmia,

bradycardia, hypoxia,

atrioventricular block, cardiac arrest,

extrasystoles, atrial fibrillation, heart

block, t wave inversion, tachycardia,

supraventricular tachycardia,

ventricular tachycardia

Liver and Biliary

System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal,

hyperbilirubinemia, alanine transaminase,

aspartate aminotransferase

Metabolic and

Nutritional

Disorders

Acidosis, respiratory acidosis,

hyperkalemia, increased alkaline

phosphatase, thirst, hypoglycemia

Psychiatric

Disorders

Agitation, confusion, delirium,

hallucination, illusion

Red Blood Cell

Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System

Disorders

Apnea, bronchospasm, dyspnea,

hypercapnia, hypoventilation, hypoxia,

pulmonary congestion

Skin and Appendages

Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision



REPORTS OF SUSPECTED PRECEDEX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Precedex. The information is not vetted and should not be considered as verified clinical evidence.

Possible Precedex side effects / adverse reactions in 23 year old male

Reported by a pharmacist from United States on 2012-03-02

Patient: 23 year old male weighing 131.0 kg (288.2 pounds)

Reactions: Bradyarrhythmia

Suspect drug(s):
Precedex



Possible Precedex side effects / adverse reactions in 57 year old male

Reported by a pharmacist from United States on 2012-03-15

Patient: 57 year old male weighing 143.0 kg (314.6 pounds)

Reactions: Agitation, Hypoxic-Ischaemic Encephalopathy, Pulse Absent, Bradycardia, Cardiac Arrest, Pulseless Electrical Activity

Adverse event resulted in: life threatening event

Suspect drug(s):
Precedex

Other drugs received by patient: Albutetol/ipratropium MDI; Clonidine; Famotidine; Amiodarone Hydrochloride; Valproic Acid; Diltiazem HCL; Dexmedetomodine Hydrochloride; Furosemide; Heparin



Possible Precedex side effects / adverse reactions in 5 month old female

Reported by a physician from Japan on 2012-04-18

Patient: 5 month old female

Reactions: Hepatitis Fulminant

Adverse event resulted in: life threatening event

Suspect drug(s):
Dopamine HCL
    Dosage: unk

Aldactone
    Dosage: unk
    Administration route: Oral

Midazolam HCL
    Dosage: unk

Acetaminophen
    Dosage: unk
    Administration route: Oral

Herbal Preparation
    Dosage: unk
    Administration route: Oral

Unfractionated Heparin

Aspirin
    Dosage: unk
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2011-12-06
    End date: 2011-12-07

Lasix
    Administration route: Oral

Precedex
    Dosage: unk



See index of all Precedex side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-21

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