FDA Safety Labeling Changes: April-June 2017

Safety Labeling Changes and Boxed Warning Highlights Approved by FDA

Teresa Rubio, PharmD

Disclosures

August 31, 2017

Editorial Collaboration

Medscape &

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.

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