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news.Safety review was the subject of FDA Early Communication in June 2008
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Amgen and Wyeth have issued a statement in response to the FDA announcement regarding the results of a safety review of Tumor Necrosis Factor (TNF) blockers. TNF blocker is marketed as Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
The safety review was the subject of FDA Early Communication in June 2008, pertaining to cases of malignancy in pediatric patients exposed to TNF blocker.
As a result of this review, FDA required strengthened warnings about the occurrence of lymphoma and other cancers in children and young adults using these medicines.
Amgen and Wyeth believe that ENBREL continues to offer a favorable benefit-risk relationship for patients with the diseases for which it is indicated to treat, including moderate-to-severe Juvenile Idiopathic Arthritis (JIA).
Amgen will work with the FDA to update the US Prescribing Information, and Medication Guide for ENBREL as described in the FDA communication. In addition, Amgen and Wyeth will communicate the revised product labeling to both physicians and patients.