Ioversol (Optiray®)
For more on this Drug Safety Labeling Change, click here for Opitray 160 (NDA-019710); Optiray 240 (NDA-020923) and Optiray 240 (NDA-019710); Optiray 300 (NDA-019710) and Optiray 300 (NDA-020923); Optiray 320 (NDA-019710) and Optiray 320 (NDA-020923); and Optiray 350 (NDA-019710) and Optiray 350 (NDA-020923).
For full prescribing information for Optiray®, click here.
Updated Boxed Warning
WARNING: NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Public Information from the FDA and Medscape
Information provided by FDA and/or its employees on this website is for educational purposes only, and does not constitute medical advice. Any statement or advice given by an FDA employee on this website does not represent the formal position of FDA. FDA and/or any FDA employee will not be liable for injury or other damages resulting to any individuals who view FDA-related materials on this website.
Cite this: FDA Safety Labeling Changes: April-June 2017 - Medscape - Aug 31, 2017.
