The Food and Drug Administration (FDA) is urging Healthcare professionals to remain vigilant about reporting cases of malignancy in patients treated with TNF blockers to MedWatch. This comes after the FDA has continued to receive reports of a rare cancer of white blood cells, known as Hepatosplenic T-Cell Lymphoma or HSTCL.
HSTCL is an aggressive cancer and is usually fatal. The majority of the reported cases were in patients that are being treated for Crohn’s disease or ulcerative colitis, but also include a patient that is being treated for psoriasis, and two patients that are being treated for rheumatoid arthritis. The 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.
The are stating that 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)