SIDE EFFECTS

A total of 1309 subjects (24 healthy volunteers and 1285 patients) received OptiMARK™ (gadoversetamide injection) Injection and 46 subjects received placebo (saline). Of the 1309 subjects who received OptiMARK™ (gadoversetamide injection) 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™ (gadoversetamide injection) Injection.

Table 5: Summary Adverse Events Experienced by ≥ 1% of the Patients

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.

Read the entire FDA prescribing information for Optimark (Gadoversetamide Injection) »