The FDA has issued another warning against giving immune system suppressants, meaning any of the biologics, to teens. They have been linked to numerous cases of a virulent lymphoma in young people taking TNF inhibitors for Rheumatoid and Psoriatic Arthritis, Crohn’s Disease, and Ulcerative Colitis. The first warning was issued in 2008.
The article, reprinted below, has been edited for clarity and brevity. The complete article can be found at the link.
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FDA Warns Again of Lymphoma Risk With TNF Blockers in Teens
Emma Hitt, PhD
April 14, 2011 — The US Food and Drug Administration (FDA) continues to receive reports of … T-cell lymphoma (HSTCL) in adolescents and young adults treated with tumor necrosis factor (TNF) blockers, azathioprine, and/or mercaptopurine, the agency said today.
HSTCL has been reported in patients taking immunosuppressive drugs for Crohn’s disease, ulcerative colitis, psoriasis, and rheumatoid arthritis, according to an alert sent today from MedWatch, the FDA’s safety information and adverse event reporting program.
Drugs associated with increased risk include the TNF blockers, a class of drugs that includes … Remicade, Enbrel, Humira, Cimzia, and Simponi. The immunosuppressive drugs azathioprine and mercaptopurine may also be associated with increased risk.
“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 FDA notes.
The FDA first warned of the increased risk for childhood and adolescent cancers associated with TNF blockers in 2008, and warnings were added to the product labels of these drugs in 2009. Warnings about HSTCL have now been added to the product labels for infliximab and adalimumab, and the product labels for azathioprine and mercaptopurine are being updated.
Healthcare professionals are advised to evaluate the potential risks and benefits of therapy carefully and discuss them with patients and caregivers.
The FDA advises clinicians to monitor patients for symptoms of HSTCL, which include [enlarged spleen], [enlarged liver], abdominal pain, persistent fever, night sweats and weight loss. Patients should also be made aware of these symptoms.
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The FDA will continue to monitor the number of reported cases of HSTCL associated with these drugs and to communicate new safety information.
HSTCL is an aggressive cancer and is usually fatal.
More information is available at the FDA Web site.