Label Changes for:

Imuran (azathioprine) Tablets and Injection

May 2011

Changes have been made to the BOXED WARNING, WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2011

 

BOXED WARNINGS

Malignancy
  • ….Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease.

WARNINGS

Inflammatory Bowel Disease
  • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with Imuran. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Some of the patients were treated with Imuran as monotherapy and some had received concomitant treatment with a TNFα blocker at or prior to diagnosis. The safety and efficacy of Imuran for the treatment of Crohn's disease and ulcerative colitis have not been established.

ADVERSE REACTIONS

  • Sweet’s Syndrome (acute febrile neurotphilic dermatosis)


 

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