Advocacy & Practice Updates — Advocacy & Practice

FDA Approves Ozurdex Safety Labeling Changes

Adverse reactions now include retinal detachment

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued safety labeling changes to 35 drugs, including Ozurdex (dexamethasone intravitreal implant, Allergan, Inc, Irvine, CA). 

The adverse reactions for Ozurdex have been amended to include postmarketing experience of retinal detachment.

To report an adverse event or side effect:

Updated: March 19, 2014