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Prialt (Ziconotide Acetate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates in clinical practice.

A total of 1254 adult patients received PRIALT as a continuous infusion in acute and severe chronic pain trials with an exposure of 662 patient-years. The mean duration of treatment was 193 days with 173 patients (14%) treated for at least 1 year. The average final dose was 17.6 mcg/day (0.73 mcg/hr).

The most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuation of PRIALT for adverse reactions [see Clinical Studies (14) and Dosage and Administration (2)].

Adverse reactions during the slow titration placebo-controlled trial that occurred in 5% or greater of patients and more commonly with PRIALT than with placebo are summarized in Table 1.

Table 1. Incidence of Adverse Reactions in Slow Titration Placebo-Controlled Trial by Percent (Events That Occurred in ≥ 5% of Patients and More Commonly with PRIALT than with Placebo)

MedDRA System Organ Class
MedDRA Preferred term

     PRIALT     
N=112

     Placebo     
N=108

Percentage of Patients

Any AE

93

82

Ear and Labyrinth Disorders

  Vertigo

7

0

Eye Disorders

  Vision Blurred

12

3

Gastrointestinal Disorders

  Diarrhea

18

15

  Nausea

40

29

  Vomiting

16

14

General Disorders and Administration Site Conditions     

  Asthenia

18

6

  Gait Abnormal

14

2

  Pyrexia

5

3

  Rigors

7

5

Infections and Infestations

  Sinusitis

5

2

Metabolism and Nutrition Disorders

  Anorexia

6

2

Musculoskeletal and Connective Tissue Disorders

  Muscle Spasms

6

4

  Pain in Limb

5

2

Nervous System Disorders

  Amnesia

8

0

  Ataxia

14

1

  Dizziness

46

13

  Dysarthria

7

0

  Dysgeusia

5

5

  Headache

13

11

  Memory Impairment

7

1

  Nystagmus

8

0

  Somnolence

17

10

  Tremor

7

3

Psychiatric Disorders

  Anxiety

8

3

  Confusional State

15

5

  Insomnia

6

9

Renal and Urinary Disorders

  Urinary Retention

9

0

Skin and Subcutaneous Disorders

  Pruritis

7

7

  Sweating Increased

5

6

Other Adverse Reactions Observed During Clinical Studies of PRIALT

The following adverse reactions assessed as related to PRIALT have been reported in 2% or greater of patients participating in the clinical studies:

EYE DISORDERS: diplopia, visual disturbance

GASTROINTESTINAL DISORDERS: abdominal pain, constipation, dry mouth, nausea aggravated

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: fall, fatigue, lethargy, edema peripheral

INVESTIGATIONS: blood creatine phosphokinase increased

METABOLISM AND NUTRITION DISORDERS: appetite decreased

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: muscle cramp, muscle weakness, myalgia, pain in limb

NERVOUS SYSTEM DISORDERS: aphasia, areflexia, balance impaired, burning sensation, coordination abnormal, disturbance in attention, dizziness postural, dysarthria, dysgeusia, hypoaesthesia, mental impairment, paraesthesia, sedation, speech disorder

PSYCHIATRIC DISORDERS: agitation, anxiety, cognitive disorder, confusional state, depression, depression aggravated, disorientation, hallucination, hallucination auditory, hallucination visual, insomnia, irritability, mood disorder, nervousness, paranoia

RENAL AND URINARY DISORDERS: dysuria, urinary hesitation

VASCULAR DISORDERS: hypotension, orthostatic hypotension.

The following medically important adverse reactions occurred in less than 2% of patients were assessed by the clinical investigators as related to PRIALT: acute renal failure, atrial fibrillation, cerebrovascular accident, sepsis, meningitis, psychotic disorder, suicidal ideation, respiratory distress, rhabdomyolysis, electrocardiogram abnormal, stupor, loss of consciousness, clonic convulsion and grand mal convulsion. Fatal aspiration pneumonia and suicide attempt were reported in less than 1% of patients.

Postmarketing Experience

The following adverse events have been reported during post-approval use of PRIALT. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypersensitivity reactions including angioedema, serious skin reactions including bullous dermatitis, skin ulcers, skin exfoliation, and burning skin sensation.



REPORTS OF SUSPECTED PRIALT SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Prialt side effects / adverse reactions in 62 year old male

Reported by a physician from France on 2011-10-04

Patient: 62 year old male weighing 77.0 kg (169.4 pounds)

Reactions: Neutropenia, Thrombocytopenia, Hypersomnia

Adverse event resulted in: hospitalization

Suspect drug(s):
Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-01
    End date: 2011-04-15

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-03
    End date: 2011-06-17

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-14
    End date: 2011-03-23

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-29
    End date: 2011-05-13

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-28

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-15
    End date: 2011-04-20

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-03
    End date: 2011-03-11

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-11
    End date: 2011-03-14

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-23
    End date: 2011-04-01

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-20
    End date: 2011-04-29

Naropin
    Dosage: see image
    Indication: Pain
    Start date: 2011-05-13
    End date: 2011-06-03

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-29
    End date: 2011-05-13

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-01
    End date: 2011-04-15

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-05-13
    End date: 2011-06-03

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-11
    End date: 2011-03-23

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-23
    End date: 2011-04-01

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-03
    End date: 2011-03-11

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-15
    End date: 2011-04-29

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-17

Clonidine HCL
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-03
    End date: 2011-06-17

Prialt
    Dosage: 0.43 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2011-03-14
    End date: 2011-03-23

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-20
    End date: 2011-04-29

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-29
    End date: 2011-05-13

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-01
    End date: 2011-04-15

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-15
    End date: 2011-04-20

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-28

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-03
    End date: 2011-06-17

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-06-17
    End date: 2011-06-28

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-23
    End date: 2011-04-01

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-05-13
    End date: 2011-06-03

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-14
    End date: 2011-03-23

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-03
    End date: 2011-03-11

Morphine Sulfate
    Dosage: see image
    Indication: Pain
    Start date: 2011-03-11
    End date: 2011-03-14



Possible Prialt side effects / adverse reactions in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient: 62 year old male

Reactions: Self-Injurious Ideation

Suspect drug(s):
Dilaudid
    Dosage: 0.17 mg, once/hour, intrathecal

Prialt
    Dosage: 0.05 ug, once/hour, intrathecal
    Start date: 2011-09-16
    End date: 2011-09-20



Possible Prialt side effects / adverse reactions in 55 year old male

Reported by a consumer/non-health professional from United States on 2011-10-27

Patient: 55 year old male weighing 92.2 kg (202.8 pounds)

Reactions: Balance Disorder, Aphasia, Deafness, Hypoaesthesia, Hallucination, Amnesia, Blindness

Adverse event resulted in: hospitalization

Suspect drug(s):
Prialt
    Dosage: 0.3 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2007-01-01
    End date: 2009-10-01

Sufentanil Citrate
    Dosage: once/hour, intrathecal



See index of all Prialt side effect reports >>

Drug label data at the top of this Page last updated: 2013-02-01

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