The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA), notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

Considerations for Healthcare Professionals :

· Discuss with patients and families the increased risk of developing cancer in children and adolescents, taking into account the clinical utility of TNF blockers, the risks/benefits of other immunosuppressive therapies, and the risks associated with untreated illness.

· Be aware of the possibility and monitor for the emergence of malignancies during and after treatment with TNF blockers.

· Be aware of the possibility and monitor for the emergence or worsening of psoriasis during treatment with TNF blockers, particularly pustular and palmoplantar forms of psoriasis.

· Understand that some immune-related diseases, such as Crohn’s, have been shown to increase cancer risk independent of treatment with TNF blockers while for others, such as juvenile idiopathic arthritis (JIA), it is unknown whether there is an increased cancer risk.

· Inform patients, their families, and caregivers of the signs and symptoms of malignancies or psoriasis so they are aware of and able to notify their healthcare professional of any unusual signs or symptoms.

Information for Patients :

· Be aware that taking TNF blockers may increase the risk of developing lymphoma, leukemia, and other cancers.

· Be aware that taking TNF blockers may increase the risk of developing psoriasis and may worsen pre-existing psoriasis.

· Review the Medication Guide that accompanies TNF blockers.

· Do not stop or change medicines that have been prescribed without first talking with a knowledgeable healthcare professional.

· Pay close attention for any signs or symptoms of cancer such as unexplained weight loss or fatigue, swollen lymph nodes in the neck, underarms or groin, or easy bruising or bleeding. Promptly discuss any signs and symptoms with a healthcare professional.

· Pay close attention for any signs or symptoms of new onset psoriasis or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus

Report Adverse Drug Reaction to the SFDA:

The public and health care professionals are strongly encouraged to report adverse drug reaction to the National Pharmacovigilance Center (NPC) by filling the appropriate form on the following link: