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Optimark (Gadoversetamide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

A total of 1309 subjects (24 healthy volunteers and 1285 patients) received OptiMARK Injection and 46 subjects received placebo (saline). Of the 1309 subjects who received OptiMARK Injection, 680 (52%) were men and 629 (48%) were women with a mean age of 50 years (range 12 to 85 years). In this population there were 1102 (84%) white, 116 (9%) black, 33 (3%) Asian, and 58 (4%) subjects and patients of other racial groups.

In the clinical trials there were 8 serious adverse events and 1 death. The one death occurred in a patient with advanced multisystem disease and appeared to be related to the underlying disease. Six of the eight serious events appeared to be related to underlying disease. Two patients had either persistent paresthesia or numbness of unknown etiology that required hospitalization for diagnostic evaluations or treatment.

Of the 1309 subjects, 460 (35%) reported at least one adverse event out of a total of 997 adverse events; and 22 (47.8%) of the 46 subjects who received placebo reported at least one adverse event out of a total of 81 adverse events.

The most commonly noted adverse events were headache (9.4%), vasodilatation (6.4%), taste perversion (6.2%), dizziness (3.7%), nausea (3.2%), and paresthesia (2.2%). All adverse events reported in 1% or greater of all patients are listed in Table 5. Of the subjects and patients who experienced adverse events, 95.8% of the adverse events were of mild or moderate intensity after dosing with OptiMARK Injection.

Table 5: Summary Adverse Events Experienced by ≥ 1% of the Patients
Body System or Event Type OptiMARK (N = 1309)
Number of patients with one or
more adverse events

460 (35.1%)
Total Number of Adverse Events 997
Patients with any injection
associated discomfort

345 (26.4%)
Body as a Whole 193 (14.7%)
Headache123 (9.4%)
Pain Abdomen24 (1.8%)
Asthenia20 (1.5%)
Pain Back16 (1.2%)
Pain13 (1.0%)
Cardiovascular 103 (7.9%)
Vasodilatation84 (6.4%)
Digestive 99 (7.6%)
Nausea42 (3.2%)
Diarrhea25 (1.9%)
Dyspepsia 16 (1.2%)
Injection Site 35 (2.7%)
Injection Site Reaction20 (1.5%)
Musculoskeletal 18 (1.4%)
Nervous System109 (8.3%)
Dizziness49 (3.7%)
Paresthesia29 (2.2%)
Respiratory 46 (3.5%)
Rhinitis20 (1.5%)
Skin and Appendages 37 (2.8%)
Special Senses 96 (7.3%)
Taste Perversion81 (6.2%)

The following adverse reactions occurred in less than 1% of the patients:

Body as a Whole: allergic reaction, edema face, fever, flu-like syndrome, malaise, mucous membrane discharge, neck rigidity, neck pain, pelvic pain, increased sweating

Cardiovascular: arrhythmia, chest pain, hypertension, hypotension, pallor, palpitation, syncope, tachycardia, vasospasm

Digestive: anorexia, increased appetite, constipation, dry mouth, dysphagia, eructation, flatulence, increased salivation, thirst, vomiting

Hemic and Lymphatic: thrombocytopenia

Metabolic and Nutritional: increased creatinine, edema, hypercalcemia, hyperglycemia, hypoglycemia, hyponatremia

Musculoskeletal: arthralgia, leg cramps, myalgia, myasthenia, spasm

Nervous System: agitation, anxiety, confusion, depersonalization, diplopia, dystonia, hallucinations, hypertonia, hypesthesia, nervousness, somnolence, tremor, vertigo

Respiratory System: asthma, cough, dyspnea, epistaxis, hemoptysis, laryngismus, pharyngitis, sinusitis, voice alteration

Skin and Appendages: application site reaction, edema injection site, erythema multiforme, pruritus, rash macular-papular and vesicullous bullous, skin dry, thrombophlebitis, inflammation injection site, urticaria

Special Senses: amblyopia, conjunctivitis, hyperacusis, parosmia, tinnitus

Urogenital: dysuria, oliguria, urine frequency.

Post-marketing surveillance reports have identified cases of seizure.



REPORTS OF SUSPECTED OPTIMARK SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Optimark side effects / adverse reactions in 58 year old female

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

Patient: 58 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Scab, Skin Burning Sensation, Skin Hyperpigmentation, Joint Stiffness, Anhedonia, Skin Swelling, Peau D'orange, Pain in Extremity, Skin Disorder, Muscular Weakness, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Hypertrophy, Livedo Reticularis, Anxiety, Scar, Mobility Decreased, Skin Fibrosis

Suspect drug(s):
Magnevist
    Indication: Imaging Procedure
    Start date: 2005-05-26
    End date: 2005-05-26

Contrast Media
    Indication: Angiogram

Prohance
    Indication: Imaging Procedure

Magnevist
    Dosage: 15 ml, unk
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2006-05-30

Contrast Media
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-12-20
    End date: 2003-12-20

Omniscan
    Indication: Imaging Procedure

Optimark
    Indication: Imaging Procedure

Multihance
    Indication: Imaging Procedure

Other drugs received by patient: Phoslo; Folbee; Epogen; Colchicine; Calcitriol; Sensipar; Klonopin; Midodrine Hydrochloride; Plavix; Synthroid; Iron Supplement; Coumadin; Aspirin; Norvasc; Zemplar; Corticosteroids; Steroid Antibacterials; Levothyroxine Sodium; Nephrocaps; Renagel; Robaxin; Immunosuppressive Agents; Hormones and Related Agents; Neurontin; Gabapentin; Immunosuppressive Agents; Antithrombotic Agents



Possible Optimark side effects / adverse reactions in 31 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-06

Patient: 31 year old female weighing 59.8 kg (131.6 pounds)

Reactions: Pruritus, Pain, Joint Contracture, Skin Burning Sensation, Joint Stiffness, Generalised Oedema, Hand Deformity, Myalgia, Joint Range of Motion Decreased, Skin Discolouration, Oedema Peripheral, Musculoskeletal Stiffness, Skin Swelling, Pain in Extremity, DRY Skin, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Stress, Skin Tightness, Anxiety, Arthralgia, Exfoliative Rash, Gait Disturbance, Atrophy

Suspect drug(s):
Magnevist
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Magnevist
    Dosage: unk
    Indication: Angiogram
    Start date: 2007-01-18
    End date: 2007-01-18

Optimark
    Indication: Angiogram

Prohance
    Indication: Angiogram

Omniscan
    Dosage: unk
    Indication: Angiogram
    Start date: 2003-01-10
    End date: 2003-01-10

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-09-22
    End date: 2003-09-22

Multihance
    Indication: Angiogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging Brain

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Dilantin; Metoprolol Tartrate; Amlodipine; Phenytoin; Morphine; Renagel; Promethazine; Aspirin; Vitamin K TAB; Diazepam; Lovenox; Labetalol HCL; Lidocaine; Ibuprofen; Plendil; Coumadin; Heparin; Methadone HCL; Norvasc; Accupril; Vicodin; Depakote; Amiodarone HCL; Pravastatin; Enoxaparin; Cardura; Cardizem; Lamictal; Clonidine; Prednisone; Elavil



Possible Optimark side effects / adverse reactions in 43 year old male

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

Patient: 43 year old male weighing 118.0 kg (259.6 pounds)

Reactions: Pain in Extremity, General Physical Health Deterioration, Skin Induration, Nephrogenic Systemic Fibrosis, Deformity, Skin Tightness, Emotional Distress, Anxiety, Skin Discolouration, Depression, Fibrosis, Mobility Decreased, Scar

Adverse event resulted in: disablity

Suspect drug(s):
Magnevist
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Dosage: 20 ml, once
    Start date: 2006-05-21
    End date: 2006-05-21

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-04-25
    End date: 2006-04-25

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Insulin [insulin]; Zemplar; Cardizem; Losartan Potassium; Albumin (Human); Aranesp; Phoslo; Catapres; Nephrocaps; Procardia XL; Procrit; Aldactone



See index of all Optimark side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-12

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