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U.S. Department of Health and Human Services

Safety

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Kenalog-10 (triamcinolone acetonide) injection and Kenalog-40 (triamcinolone acetonide) injection

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

 

July 2011

Summary View

WARNINGS

General
  • rare instances of anaphylaxis......

ADVERSE REACTIONS

Allergic Reactions
  • anaphylaxis

 

June 2011

Summary View

 

WARNING

  • add information that Kenalog is not for epidural use and to add information to the Warning section that epidural use is not recommended.
Neurologic
  • to include information regarding adverse events with epidural administration of corticosteroids.

ADVERSE REACTIONS

  • revisions to the products labels to include information regarding adverse events with epidural administration of corticosteroids.