FDAnews Drug Daily Bulletin

PHYSICIANS ALERTED TO NEW WARNING FOR ONTAK

March 28, 2006
A A

Ligand Pharmaceuticals and FDA have notified healthcare professionals of a new visual loss warning for the company's lymphoma drug Ontak.

The information added to the warnings section of the package insert for Ontak (denileukin diftitox) states: "Loss of visual acuity, usually with loss of color vision with or without retinal pigment mottling, has been reported following administration of Ontak. Recovery was reported in some of the affected patients, however most patients reported persistent visual impairment."

Ontak is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma.