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Washington, DC-The FDA and Ligand Pharmaceuticals Inc. arewarning of the risk for visual loss associated with the use ofdenileukin diftitox injection (Ontak), a drug used in patients withpersistent or recurrent cutaneous T-cell lymphoma whose malignantcells express the CD25 component of the interleukin-2 receptor.
Washington, DC-The FDA and Ligand Pharmaceuticals Inc. are warning of the risk for visual loss associated with the use of denileukin diftitox injection (Ontak), a drug used in patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin-2 receptor.
The FDA has received reports of loss of visual acuity, usually with loss of color vision with or without retinal pigment mottling, after administration of Ontak. Although some patients recovered, most reported persistent visual impairment. Because this adverse event was reported voluntarily from a population of uncertain size, the incidence rate for visual loss and its relationship to drug exposure remain unclear, the FDA said.
More information on this report may be obtained by contacting the company at 800/964-5836. To report adverse events with Ontak, call the number above or fax to 800/FDA-1088, go online at http://www.fda.gov/medwatch/, or send mail to 5600 Fishers Lane, Rockville, MD 20852-9787.