Inpharma 1644 - 28 Jun 2008 FDA wants warnings on Enbrel label The US FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee is recommending that labelling for Amgen’s Enbrel [etanercept] include warnings that use of the agent in paediatric patients may lead to moderate to severe infections and can result in death. The committee’s postmarketing review of etanercept found that the tumour necrosis factor (TNF) antagonist was associated with serious adverse events in children and adolescents such as infections and malignancies, similar to adults. It expressed concern regarding both the number and types of postmarketing adverse events, given that the estimated use of etanercept in the paediatric population is relatively low at this point. The committee recommended the following labelling changes: • Under the ’Adverse Reactions in Patients with Juvenile Idiopathic Arthritis’ section, the wording should be changed to reflect that use of etanercept therapy in the paediatric population may lead to moderate to severe infections and can result in serious outcomes, including death and hospitalisation. • In the same section, the list of serious adverse events reported in the postmarketing period should be updated to include macrophage activation syndrome, malignancies, diabetes mellitus and systemic lupus erythematosus. FDA. Enbrel (etanercept) for the treatment of pediatric plaque psoriasis. Internet Document : [95 pages], 18 Jun 2008. Available from: URL: http:// www.fda.gov 801075282 » Editorial comment: At the start of June, the US FDA issued an early communication regarding its ongoing safety review of TNF antagonists, advising parents and clinicians to be aware of the possible risk of lymphoma and other cancers [see Inpharma 1642 p18; 809089774]. 1 Inpharma 28 Jun 2008 No. 1644 1173-8324/10/1644-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

FDA wants warnings on Enbrel label regarding paediatric use

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Inpharma 1644 - 28 Jun 2008

FDA wants warnings on Enbrellabel

The US FDA’s Dermatologic and Ophthalmic DrugsAdvisory Committee is recommending that labelling forAmgen’s Enbrel [etanercept] include warnings that useof the agent in paediatric patients may lead to moderateto severe infections and can result in death.

The committee’s postmarketing review of etanerceptfound that the tumour necrosis factor (TNF) antagonistwas associated with serious adverse events in childrenand adolescents such as infections and malignancies,similar to adults. It expressed concern regarding boththe number and types of postmarketing adverse events,given that the estimated use of etanercept in thepaediatric population is relatively low at this point. Thecommittee recommended the following labellingchanges:• Under the ’Adverse Reactions in Patients with

Juvenile Idiopathic Arthritis’ section, the wordingshould be changed to reflect that use of etanercepttherapy in the paediatric population may lead tomoderate to severe infections and can result inserious outcomes, including death andhospitalisation.

• In the same section, the list of serious adverseevents reported in the postmarketing period shouldbe updated to include macrophage activationsyndrome, malignancies, diabetes mellitus andsystemic lupus erythematosus.

FDA. Enbrel (etanercept) for the treatment of pediatric plaque psoriasis. InternetDocument : [95 pages], 18 Jun 2008. Available from: URL: http://www.fda.gov 801075282

» Editorial comment: At the start of June, the US FDA issuedan early communication regarding its ongoing safety review ofTNF antagonists, advising parents and clinicians to be aware ofthe possible risk of lymphoma and other cancers [see Inpharma1642 p18; 809089774].