Label Changes for:

Ozurdex (dexamethasone intravitreal implant) 0.7 mg

September 2014

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

September 2014

4 CONTRAINDICATIONS

4.2 Glaucoma
  • OZURDEX is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.
4.3 Torn or Ruptured Posterior Lens Capsule
  • OZURDEX is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX use.
4.4 Hypersensitivity
  • OZURDEX is contraindicated in patients with known hypersensitivity to any components of this product [see Adverse Reactions (6)].

5 WARNINGS AND PRECAUTIONS

5.2 Steroid-related Effects
  • Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience
  • revised to include revised intraocular pressure data and adverse reaction data for the diabetic macular edema indication

 

 

February 2014

ADVERSE REACTIONS

6.2 Postmarketing Experience
  • retinal detachment

 

September 2012

CONTRAINDICATIONS

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.

ADVERSE REACTIONS

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).

 

 

February 2012

 

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.

 

ADVERSE REACTIONS

Postmarketing Experience
  • 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.

 

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