FDA Warns of Visual Acuity Loss After Ontak; Loss Often Persistent

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MedWatch - The FDA Safety Information and Adverse Event

Reporting Program

Ligand Pharmaceuticals and FDA notified healthcare

professionals of changes

to the WARNINGS section of the prescribing information for

Ontak (denileukin diftitox), indicated for the treatment of

patients with

persistent or recurrent cutaneous T-cell lymphoma.

Loss of visual acuity, usually with loss of color vision,

has been

reported following administration of Ontak.

While recovery was reported in some of the affected

patients, most patients

reported persistent visual impairment.

Read the complete MedWatch 2005 Safety summary, including

links to the Dear

Healthcare professional letter and revised label, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#ontak