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Details with Side Effects
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
The following information is based on the combined clinical trial results from 3 initial, randomized, 6-month, sham-controlled studies (2 for retinal vein occlusion and 1 for posterior segment uveitis):
Adverse Reactions Reported by Greater than 2% of
Patients in the First Six Months
|Intraocular pressure increased||125 (25%)||10 (2%)|
|Conjunctival hemorrhage||108 (22%)||79 (16%)|
|Eye pain||40 (8%)||26 (5%)|
|Conjunctival hyperemia||33 (7%)||27 (5%)|
|Ocular hypertension||23 (5%)||3 (1%)|
|Cataract||24 (5%)||10 (2%)|
|Vitreous detachment||12 (2%)||8 (2%)|
|Headache||19 (4%)||12 (2%)|
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.
Following a second injection of OZURDEX® in cases where a second injection was indicated, the overall incidence of cataracts was higher after 1 year.
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: complication of device insertion (implant misplacement), device dislocation with or without corneal edema, endophthalmitis, hypotony of the eye (associated with vitreous leakage due to injection), and retinal detachment.
Read the Ozurdex (dexamethasone intravitreal implant) Side Effects Center for a complete guide to possible side effects
Additional Ozurdex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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