FDA requires label change for TNF-blocker drugs

The FDA on Thursday announced that the manufacturers of four tumour necrosis factor (TNF) blockers will be required to strengthen existing warnings on the drugs' labels about the risk of developing opportunistic fungal infections. The products in question are Johnson & Johnson's Remicade (infliximab), Wyeth's and Amgen's Enbrel (etanercept), Abbott's Humira (adalimumab), and UCB's Cimzia (certolizumab).

The prescribing information for the drugs already includes data about the risk of serious infections in patients administered the treatments. However, the FDA stated that based on reports it reviewed, "healthcare professionals are not consistently recognising cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment." The agency specified that in at least 21 reports it reviewed, histoplasmosis was not initially recognised and treated, and 12 patients died.

In ordering the update, the FDA invoked new authorities from a 2007 law, allowing it to demand that drugmakers make safety-related labelling changes to their products. In response to the news, Amgen stated that it "will work with the agency to finalise and communicate revised product labelling for Enbrel."

In June, the US regulator said it was investigating a possible association between TNF-blocker drugs and the development of certain cancers in children and young adults.

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