On March 3,
2006, the Division of Biologic Oncology
Products in FDA's Office of Oncology Drug
Products (OODP) approved changes to the
product labeling for denileukin diftitox (Ontak)
to include a new warning on ophthalmologic
adverse events. This information is based on
post-marketing studies and spontaneous
reports.
Ontak (denileukin diftitox) was approved in
February 1999 to be used for the treatment of
persistent or recurrent cutaneous T-cell
lymphoma (orphan indication).
The
following statement has been added to the
WARNINGS section of the Ontak label:
“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 statement has been added to the
ADVERSE REACTIONS section of the Ontak label
as follows:
“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”
Full prescribing information, including
clinical trial information, safety, dosing,
drug-drug interaction, contraindications is
available at:
Drugs@FDA.
Healthcare professionals should report all
serious adverse events suspected to be
associated with the use of any medicine and
device to FDA’s MedWatch Reporting System by
phone at 1-800-FDA-1088; by facsimile
1-800-FDA-0178 by mail using the Form 3500 at
http://www.fda.gov/medwatch.index.html.
For further information related to oncology
drug approvals, regulatory information, and
other oncology resources, please refer to the
FDA “Oncology Tools” website at
www.fda.gov/cder/cancer.
.gif){kind=spacer}
