Label Changes for:

Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL and 20 mg/mL Parenteral

June 2009

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

WARNINGS

General
  • Results from one multicenter, randomized, placebo controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of corticosteroids, including Aristospan, should not be used for the treatment of traumatic brain injury.
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