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azathioprine FDA Alerts

The FDA Alert(s) below may be specifically about azathioprine or relate to a group or class of drugs which include azathioprine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for azathioprine

Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Nov 4, 2011

Audience: Rheumatology, Gastroenterology, Oncology, Dermatology

 

[UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include:

  • patient characteristics (age, gender, no patient identifiers)
  • risk factors for malignancy
  • exposure to other immune suppressing products or products with risk of malignancy
  • indication for TNF blocker treatment
  • TNF blocker exposure (duration, dose)
  • cancer diagnosis (date of diagnosis, stage)
  • biopsy results
  • outcomes of malignancy (treatments, event outcome)

 

[Posted 04/14/2011]

ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.  TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

RECOMMENDATIONS:

  • Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
  • Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
  • Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[11/03/2011 - Drug Safety Communication - FDA]
[04/14/2011 - Drug Safety Communication - FDA]

Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Apr 14, 2011

Audience: Rheumatology, Gastroenterology, Oncology, Dermatology

[Posted 04/14/2011]

ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.  TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

RECOMMENDATIONS:

  • Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
  • Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
  • Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[04/14/2011 - Drug Safety Communication - FDA]

Azathioprine Tablets, 50 mg

Jul 13, 2006

Audience: Pharmacists and other healthcare professionals

[Posted 07/13/2006] Roxane Laboratories and FDA notified pharmacists and other healthcare professionals of a nationwide recall of a single manufacturing lot of Azathioprine tablets, 50 mg (Lot 558470A, Exp Mar 2009) used to help prevent rejection in kidney transplant patients, and to manage severe rheumatoid arthritis. The recall was initiated due to concerns that bottles from this single lot # 558470A, labeled as Azathioprine may contain Methotrexate, 2.5 mg tablets. Information has been sent to pharmacists alerting them of the details pertaining to this recall. Pharmacists who may have dispensed Azathioprine tablets to patients from manufacturing lot 558470A are instructed to contact those patients to assure they did not inadvertently receive Methotrexate tablets.

[July 13, 2006 – Press Release – Roxane]

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