ADVERSE REACTIONS TO CONTRAST MATERIAL

• Allergic Reactions-It is impossible to predict which patients will have an adverse reaction to IV administration of contrast material. If an patient has a history of a previous adverse reaction, is hypotensive, in congestive heart failure, pheochromocytoma, multiple myeloma, diabetes mellitus, or has severe renal disease, then contrast material should not be administered. If it is necessary to do so, then it is best to use a non-ionic, iodinated contrast material. It may be beneficial to prophyllactically treat the patient with antihistamines. And, these patients should be closely monitored. In humans, signs may be mild consistenting of nausea, metallic taste sensation, burning sensation in the arm during injection. In these cases, no treatment is generally needed besides monitoring for progression of signs. Signs may progress to flushing of the skin and urticaria. Treatment with antihistamines may be warranted. In moderately severe cases, breathing may become difficult and treatment with steroids may be warranted. In severe cases of anaphylaxis, full CPR may be necessary.
• Acute Renal Failure - Occasionally, acute renal failure may result following IV administration of iodinated contrast material. Aggressive treatment with fluids, dopamine, lasix, and mannitol may be warranted.
• Aspiration - Aspiration of small volumes of barium sulfate suspension is usually incidental. The barium is eliminated by coughing and the mucocilliary apparatus. The remainder of the barium is removed by macrophages and will accumulate in the tracheobronchial lymph nodes which will then appear opaque for years. Aspiration of large volumes of barium can cause suffocation and suction may be necessary to remove the barium. If gastric contents or other material is aspirated, then pneumonia may result. Often, this is treatable with antibiotics. Aspiration of nonionic, iodinated contrast material may lead to pulmonary edema.
• Pulmonary Edema - Life threatening pulmonary edema may develop if iodinated (especially ionic) contrast material is administered into the lungs. Aggressive treatment including oxygen, lasix, and steroids may be necessary.
• Seizure - One of the most common adverse reaction to myelography is seizures, especially after cervical injections. These typically occur during recovery from anesthesia or within the next 24 hours. They typically are self-limiting and can be managed with valium or anesthesia. Injection of ionic contrast material during myleography typically results in severe seizures and death.
• Peritonitis - Barium will induce granulomas when administered within the peritoneal cavity. This may have mild, inconsequential effects or result in severe abdominal adhesions, abdominal pain, and possible decompensation of the patient. Barium has been injected into the mediastinum of cats with minimal granuloma formation.

Classification of reactions to contrast agent reactions

More information extracts

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DRUG INTERACTIONS

Diabetic nephropathy may predispose to renal impairment following intravascular contrast medium administration. This may precipitate lactic acidosis in patients who are taking biguanides. As a precaution, biguanides should be stopped 48 hours prior to the contrast medium examination.

Hypersensitivity reactions can be aggravated in patients on beta-blockers, and these patients may be refractory to standard treatment with beta agonists.

The prevalence of delayed reactions (e.g. fever, rash, flulike symptoms, joint pain and pruritus) to iodinated contrast media is higher in patients who have received interleukin, as long as several months prior to the administration of iodinated contrast medium.

Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in patients who have recently received a cholecystographic contrast agent.

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ADVERSE REACTIONS


The following table of incidence of reactions is based upon controlled clinical trials in which ULTRAVIST^® Injection was compared with nonionic contrast agents (iohexol, iopamidol, ioversol) in 1367 patients. This listing includes all reported adverse reactions regardless of attribution.

Adverse reactions are listed by body system and in decreasing order of occurrence greater than 0.5% in the iopromide group.

One or more adverse reactions were recorded in 229 of 708 (32%) patients during the clinical trials, coincidental with the administration of ULTRAVIST^® Injection or within the defined duration of the study follow-up period (24-72 hours). The incidence and type of adverse reactions were similar to those of the studied nonionic comparators (iohexol, iopamidol, ioversol) used in the clinical trials. Also, as with other contrast agents, ULTRAVIST^® Injection is often associated with sensations of warmth and/or pain. The incidence is similar to the other nonionic contrast comparators.

Serious, life-threatening and fatal reactions have been associated with the administration of iodine-containing contrast media, including ULTRAVIST^® Injection. In clinical trials 7/708 patients given ULTRAVIST^® Injection and 4/659 given a comparator died 5 days or later after drug administration. Also, 8/708 patients given ULTRAVIST^® Injection and 4/659 given a comparator had serious adverse events. Rare reports of death due to anaphylaxis and thrombosis have been documented during foreign postmarketing surveillance.

The following adverse reactions were observed in less than or equal to 0.5% of the subjects receiving ULTRAVIST^® Injection:

BODY: abdominal pain, asthenia, chills, dry mouth, edema of the face, fever, malaise, neck pain; CARDIOVASCULAR: AV block (complete), bradycardia, coronary thrombosis, hypoxia, peripheral vascular disorder, pulmonary hypertension, sweating increase, syncope, vascular anomaly, ventricular extrasystoles; DIGESTIVE: constipation, diarrhea, dyspepsia, salivation increase, sore throat; INJECTION SITE REACTIONS: edema, erythema, rash; METABOLIC: excessive thirst; MUSCULOSKELETAL: arthralgia, myasthenia; NERVOUS SYSTEM: agitation, anxiety; convulsion, depression, emotional lability, hypertonia, hypesthesia, incoordination, insomnia, neuropathy, speech disorder, tremor; RESPIRATORY: apnea, asthma, cough increased, pharyngitis, respiratory disorder (unspecified); SKIN AND APPENDAGES: pruritus, rash; SPECIAL SENSES: visual field defect; UROGENITAL: dysmenorrhea, kidney pain.

Additional adverse events reported in foreign postmarketing surveillance and other trials with the use of ULTRAVIST^® Injection include: apparent hypersensitivity reactions, congestive heart failure, tachycardia, ventricular fibrillation, hemopericardium, aphasia, tongue paralysis, amnesia, hypotonia, mydriasis, lacrimation disorder, hematuria, renal failure, and skin discoloration.


The overall character, quality, and severity of adverse reactions in pediatric patients is similar to that reported in adult populations from domestic and foreign postmarketing surveillance and other information. Additional adverse reactions reported in pediatric patients from foreign marketing surveillance or other information are: epistaxis, angioedema, migraine, joint disorder (effusion), muscle cramps, mucous membrane disorder (mucosal swelling), conjunctivitis, hypoxia, fixed eruptions, vertigo, diabetes insipidus, and brain edema.

OVERDOSAGE

The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
ULTRAVIST^® Injection binds negligibly to plasma or serum protein and can, therefore, be dialyzed.

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Guidelines with Regard to Metformin-Induced Lactic Acidosis and X-ray Contrast Medium Agents