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Imuran FDA Alerts

The FDA Alerts below may be specifically about Imuran or relate to a group or class of drugs which include Imuran.

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.

Recent FDA Alerts for Imuran

FDA Alerts Health Care Professionals of Pregnancy Problems Associated with Thiopurines

Apr 29, 2024 | Audience: Health Care Professionals

April 29, 2024 -- FDA is alerting health care professionals of the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines (azathioprine, 6-mercaptopurine, and 6-thioguanine).

Thiopurines are immunosuppressants with a known risk of hepatotoxicity and are currently labeled for risk of fetal harm with use during pregnancy. Pregnant patients should stop using thiopurines if they develop ICP. FDA is requiring manufacturers to update labeling to include additional warning information on the risk of ICP associated with thiopurines.

Reported cases of ICP occurred among pregnant patients using azathioprine or 6-mercaptopurine primarily to treat inflammatory bowel disease (IBD)—including Crohn's disease (CD) and ulcerative colitis (UC)—or systemic lupus erythematosus (SLE). Thiopurines are not FDA-approved to treat CD, UC, or SLE; however, the American Gastroenterological Association and the American College of Rheumatology have published treatment guidelines indicating that azathioprine or 6-mercaptopurine may be appropriate to continue on an individualized basis for management of some immunologic conditions during pregnancy.

FDA is requiring all new drug application and abbreviated new drug application holders for azathioprine, 6-mercaptopurine, and 6-thioguanine drug products to include the below key pieces of information in updated labeling:

  • Postmarketing cases of ICP have been reported in women treated with drugs in the thiopurine class during pregnancy.

  • ICP symptoms and elevated bile acid levels improved following azathioprine discontinuation.

  • Pregnant persons should discontinue use of thiopurines if they develop ICP.

Health care professionals, caregivers, and patients should report adverse events or side effects related to the use of any medicines to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source: FDA

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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