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:
- Complete the online MedWatch Voluntary Reporting Form.
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.
- Complete the ASRS Adverse Event Report Form.
Updated: March 19, 2014