Label Changes for:
Ozurdex (dexamethasone intravitreal implant) 0.7 mg
Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
4.3 Aphakic Eyes with Rupture of the Posterior Lens Capsule
- Ozurdex is contraindicated in patients who have aphakic eyes with rupture of the posterior lens capsule.
4.4 ACIOL and Rupture of the Posterior Lens Capsule
- Ozurdex is contraindicated in eyes with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule.
6.2 Postmarketing Experience
- added .....complication of device insertion (implant misplacement), device dislocation with or without corneal edema, endophthalmitis, and hypotony of the eye (associated with vitreous leakage due to injection).
WARNINGS AND PRECAUTIONS
Risk of Implant Migration
- Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.
- The following reactions have been identified during post-marketing use of Ozurdex in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Ozurdex or a combination of these factors, include: device dislocation and endophthalmitis.