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U.S. Department of Health and Human Services

Safety

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Retisert (fluocinolone acetonide intravitreal implant) August 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Cataract Formation
  • Increase in Intraocular Pressure

ADVERSE REACTIONS

  • Clinical Trials Experience – Ocular Events
  • Clinical Trials Experience – Non-Ocular Events

PATIENT COUNSELING INFORMATION

WARNINGS AND PRECAUTIONS

Cataract Formation

Use of corticosteroids may result in posterior subcapsular cataract formation.

Based on clinical trials with Retisert, during the 3-year post implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

Increase in Intraocular Pressure

...Based on clinical trials with Retisert, within 3-years post implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure...

Label approved 08/05/2008 is not available on this site

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