A SERVICE
OF 
Simulect
Associated with Hypersensitivity Reactions
EAST HANOVER, N.J.: October 15, 2000 · by TNN Medical Reporter
Virginia Baskerville
- The kidney antirejection drug Simulect (basiliximab) has been
associated with 17 cases of severe acute hypersensitivity reactions, including
anaphylaxis, according to a "Dear Healthcare Provider" letter recently issued
by the drug's maker, Novartis Pharmaceuticals Corporation.
In a retyped
text of the letter posted by the Food and Drug Administration's MedWatch at
www.fda.gov/medwatch/safety/2000/simule.htm, Novartis said
that the hypersensitivity reactions began within 24 hours following initial
exposure or re-exposure to Simulect.
"Therefore, we recommend that
medications for the treatment of severe hypersensitivity reactions, including
anaphylaxis, be available for immediate use and that the second dose of
Simulect be withheld if a hypersensitivity reaction occurs," the letter said.
In addition, the letter said that Simulect should be permanently discontinued
if a severe hypersensitivity reaction occurs.
Simulect was approved in
1998 in both the United States and Europe for the prevention of acute rejection
of transplanted kidneys. Transplant News Network reported on
September 1, 2000 ("Regulatory News: Rapamune, Simulect, Thymoglobulin"), that
the Committee for Proprietary Medicinal Products of the European Medicines
Evaluation Agency had recommended extended labeling for Simulect that included
use in pediatric renal transplantation.
Novartis is urging health care
professionals to report all serious adverse events that could be related to the
use of Simulect to Novartis Pharmaceuticals Corporation, 59 Route 10, East
Hanover, NJ 07936; (888) NOW-NOVARTIS or (888-669-6682); or
www.novartis.com.
Alternatively, the information can be reported to FDA's MedWatch Reporting
System by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; or by submitting
Form 3500 online at
www.accessdata.FDA.gov/scripts/medwatch or by mail to
MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
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