The US Food and Drug Administration (FDA) is requiring the manufacturers of Tumour Necrosis Factor (TNF) blockers to update the Boxed Warning in the prescribing information to alert healthcare professionals of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.
The FDA analysed 48 cases of malignancy in children taking TNF blockers and concluded that there was a small increased risk that health professionals and patients should be aware of. This is an example of post-marketing surveillance case reports highlighting adverse effects in newly licensed treatments which may not have been apparent in the randomised controlled trials prior to their launch.