"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
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 the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Serious and Otherwise Important Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of labeling.
- Increased Bleeding Time (WARNINGS AND PRECAUTIONS)
- Delayed Healing (WARNINGS AND PRECAUTIONS)
- Corneal Effects (WARNINGS AND PRECAUTIONS)
Ocular Adverse Reactions
The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients.
Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment.
Some of these reactions may be the consequence of the cataract surgical procedure.
Non-Ocular Adverse Reactions
Last reviewed on RxList: 1/4/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Ilevro 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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