Clinical Updates — Clinical Updates
FDA Announces Ozurdex and MembraneBlue Safety Labeling Changes
Contraindications, warnings and precautions, adverse reactions updated
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has announced safety labeling changes for Ozurdex (dexamethasone intravitreal implant, Allergan, Inc, Irvine, CA) and MembraneBlue 0.15% (trypan blue ophthalmic solution, DORC International, Zuidland, Netherlands).
Ozurdex safety labeling changes
Contraindications have been expanded to include:
- Glaucoma. Patients with glaucoma who have cup-to-disc ratios of greater than 0.8 should not use Ozurdex.
- Torn or ruptured posterior lens capsule. Ozurdex is contraindicated in patients whose posterior lens capsule is torn or ruptured due to the risk of migration into the anterior chamber. However, laser posterior capsulotomy in pseudophakic patients is not a contraindication for Ozurdex use.
- Hypersensitivity. Ozurdex is contraindicated in patients with known hypersensitivity to any of the product's components.
- Steroid-related effects. Corticosteroid use is not recommended in patients with a history of ocular herpes simplex due to the potential for reactivation of the viral infection.
- Clinical studies experience. Adverse reactions have been updated to include revised intraocular pressure data and adverse reaction data for the diabetic macular edema indication.
MembraneBlue safety labeling changes
Warnings and precautions now include:
- Priming of the syringe. Make sure the plunger moves smoothly before use: first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid.
To report an adverse event or side effect:
- 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.
Updated October 16, 2014