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FDA Drug Warning Letter On ONTAK
03 March 2006
Dear Health Care Professional:
Ligand Pharmaceuticals Inc. is writing to inform you of changes to the product labeling for ONTAK (denileukin diftitox). These changes are being made to alert physicians/health care professionals to new post-marketing adverse events.
The following new information has been added to the Package Insert for ONTAK.
The following statement has been added under WARNINGS:
Visual Loss:
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.
The following statements have been added under ADVERSE REACTIONS:
Post-Marketing:
The following adverse reactions have been identified during post approval use of ONTAK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Special Senses: See WARNINGS: Visual Loss
Please refer to the accompanying revised full prescribing information for ONTAK, including boxed warning.
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