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Drug Alert


Mar 26, 2014: Drug Alert: Immunosuppressants Imuran or Purinethol Associated with a Type of Blood Cancer


Health Canada is informing Canadians that certain immunosuppressant medications are linked to increased risk of developing a type of blood cancer called hepatosplenic T-cell lymphoma.

IMURAN® is a drug used to treat adult rheumatoid arthritis and help prevent kidney transplant rejection. PURINETHOL® is a drug approved to treat cancer (leukemias). IMURAN® and PURINETHOL® are not approved in Canada for the treatment of Inflammatory Bowel Disease (IBD) such as ulcerative colitis, but are sometimes used for such as an off-label use.

Hepatosplenic T-cell lymphoma (HSTCL) is a rare1, aggressive and often fatal cancer.
&nbsp&nbsp&nbsp&nbsp•&nbsp&nbsp Cases of Hepatosplenic T-cell Lymphoma (including deaths) have been reported in IBD patients treated with IMURAN® (azathioprine) or PURINETHOL® (mercaptopurine).
&nbsp&nbsp&nbsp&nbsp•&nbsp&nbsp IMURAN® and PURINETHOL® labels have been updated to include the associated risk of HSTCL.
&nbsp&nbsp&nbsp&nbsp•&nbsp&nbsp Patients should discuss the current information regarding risks and benefits of these treatments with their doctors.

Cases of HSTCL (including deaths) have been reported with the use of IMURAN® and PURINETHOL® in Canada and internationally mostly in patients where it is used to treat inflammatory bowel disease (IBD). A total of 238 cases of HSTCL have been reported worldwide1, indicating this cancer is rare.

Triton Pharma Inc. and Teva Canada Ltd. have sent a letter to healthcare professionals informing them of this safety information. This letter can be obtained on the Canadian website of Triton Pharma Inc. and Teva Canada Ltd. or on the Healthy Canadians Web site. If you have questions regarding your IMURAN® or PURINETHOL® prescriptions, please contact your doctor.

The complete prescribing and adverse event information for IMURAN® can be found in the approved Product Monograph2 which is available on the Health Canada website and on the Triton Pharma Inc. website.

The complete prescribing and adverse event information for PURINETHOL® can be found in the approved Product Monograph3 which is available on the Health Canada website and on the Teva Canada Ltd. website.