Optiray Side Effects

Please note - some side effects for Optiray may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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Optiray

Adverse reactions following the use of Optiray formulations are usually mild to moderate, of short duration and resolve spontaneously (without treatment). However, serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media.

Injections of contrast media are often associated with sensations of warmth and pain. In controlled double-blind clinical studies, significantly less warmth and pain were associated with the injection of Optiray than with iothalamate meglumine, diatrizoate meglumine, and diatrizoate meglumine and diatrizoate sodium.

When Optiray was used for coronary arteriography and ventriculography in double-blind clinical trials, electrocardiographic and hemodynamic changes occurred with less frequency and severity with ioversol injection than with diatrizoate meglumine and diatrizoate sodium.

Following coronary artery and left ventricular injection, electro-cardiographic parameters were affected less with Optiray (ioversol injection) than with diatrizoate meglumine and diatrizoate sodium injection. These parameters included the following: bradycardia, tachycardia, T-wave amplitude, ST depression and ST elevation.

Optiray has also been shown to cause fewer changes in cardiac function and systemic blood pressure than conventional ionic media. These include cardiac output, left ventricular systolic and end-diastolic pressure, right ventricular systolic and pulmonary artery systolic pressures and decreases in systolic and diastolic blood pressures.

The following table of incidence of reactions is based upon clinical trials with Optiray formulations in 2,098 patients. This listing includes all adverse reactions which were coincidental to the administration of ioversol regardless of their direct attributability to the drug or the procedure. Adverse reactions are listed by organ system and in decreasing order of occurrence. Significantly more severe reactions are listed before others in a system regardless of frequency.

Regardless of the contrast medium employed, the overall incidence of serious adverse reaction is higher with coronary arteriography than with other procedures. Cardiac decompensation, serious arrhythmias, myocardial ischemia or myocardial infarction may occur during coronary arteriography and left ventriculography.

Pediatrics: In controlled clinical trials involving 159 patients for pediatric angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography, adverse reactions reported were as follows: fever (1.3%), nausea (0.6%), muscle spasm (0.6%), LV pressure changes (0.6%).

General Adverse Reactions to Contrast Media

The following adverse reactions are possible with any parenterally administered iodinated contrast medium. Severe life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. Based upon clinical literature, reported deaths from the administration of conventional iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent).

The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast medium, the dose and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the dose injected, the speed of injection, the mode of injection and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

In addition to the adverse reactions reported for ioversol, the following additional adverse reactions have been reported with the use of other contrast agents and are possible with any water soluble, iodinated contrast agent.

Nervous: convulsions, aphasia, paralysis, visual field losses which are usually transient but may be permanent, coma and death.

Cardiovascular: angioneurotic edema, peripheral edema, vasodilation, thrombosis and rarely thrombophlebitis, disseminated intravascular coagulation and shock.

Skin: maculopapular rash, erythema, conjunctival symptoms, ecchymosis and tissue necrosis.

Respiratory: choking, dyspnea, wheezing which may be an initial manifestation of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm, apnea and cyanosis. Rarely these allergic-type reactions can progress into anaphylaxis with loss of consciousness, coma, severe cardiovascular disturbances and death.

Miscellaneous: hyperthermia, temporary anuria or other nephropathy.

Other reactions may also occur with the use of any contrast agent as a consequence of the procedural hazard; these include hemorrhage or pseudoaneurysms at the puncture site, brachial plexus palsy following axillary artery injections, chest pain, myocardial infarction, and transient changes in hepatorenal chemistry tests. Arterial thrombosis, displacement of arterial plaques, venous thrombosis, dissection of the coronary vessels and transient sinus arrest are rare complications.

(Adverse reactions for specific procedures receive comment in the Indications, Usage and Procedural Information section.)

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