Amgen and Wyeth announce Enbrel label changes

Amgen and Wyeth Pharmaceuticals have announced changes to the prescribing information for Enbrel (etanercept).

The companies report that the prescribing information in the US now contains boxed data which warns of the risks relating to infections, including tuberculosis.

It notes that this labelling is similar to those for other tumour necrosis factor inhibitor class drugs.

Prior to this change, the prescribing information included a warning relating to the risk of infections and tuberculosis in bold, while the boxed warning also includes additional information regarding patient screening and monitoring for tuberculosis.

Enbrel is indicated for a number of conditions, including improving physical functions in patients with moderate to severe rheumatoid arthritis and reducing the signs and symptoms of moderately to severely active polyarticulare juvenile idiopathic arthritis.

“The primary concern of both Amgen and Wyeth is for the safety of patients, and both companies maintain an ongoing pharmacovigilance program to analyse and evaluate all safety reports from clinical and open-label trials as well as post-marketing surveillance,” the companies report.

They add that the risks defined in the boxed warning are consistent with those previously included in the US prescribing information for the drug.

Last month, Amgen and Wyeth announced the findings of a retrospective analysis showing that Enbrel lowers the level of c-reactive protein in patients with moderate to severe plaque psoriasis.