JerseyRoche’s selective 5-HT3
receptor antagonist Kytril Injection (granisetron) has received FDA approval
for both the prevention and treatment of postoperative nausea and vomiting. The
FDA first approved Kytril Injection in December 1993 for chemotherapy-induced
nausea and vomiting. Kytril oral tablets were approved in July 1999 for use in
radiotherapy-induced nausea and vomiting.
When used for prevention, Kytril is given just before or
during surgery. In the case of treatment, Kytril is given to a patient who
experiences nausea and vomiting after surgery is completed. The approval was
based on several randomized, double-blind, clinical trials showing that Kytril,
at a variety of doses, is more effective than placebo in both the prevention
and treatment of postoperative nausea and vomiting.
"There is a need for alternative therapies for postoperative nausea and
vomiting," said T. J. Gan, MD, associate professor and director of
clinical research, Department of Anesthesiology, Duke University Medical
Center. Dr. Gan noted that patients who fail treatment with other antiemetics
may be subjected to extended periods of nausea and vomiting and that these
patients may be successfully managed with Kytril.