FDA Approves Kytril for Postoperative Nausea and Vomiting

October 1, 2002

The US Food and Drug Administration (FDA) has approved granisetron (Kytril) for the prevention and treatment of postoperative nausea and vomiting. The approval was based on the results of recent clinical trials.

The US Food and Drug Administration (FDA) has approved granisetron (Kytril)for the prevention and treatment of postoperative nausea and vomiting. Theapproval was based on the results of recent clinical trials.

Postoperative Prevention

As a preventive antiemetic agent, granisetron was evaluated in tworandomized, double-blind, placebo-controlled trials in patients who underwentgynecologic surgery or cholecystectomy and received general anesthesia. In onestudy, patients between the ages of 18 and 88 years received a singleintravenous dose of granisetron (0.1, 1, or 3 mg) or placebo 5 minutes prior tothe induction of anesthesia. In another study, patients between the ages of 21and 64 years received a single intravenous dose of granisetron (1 or 3 mg) orplacebo immediately before the reversal of anesthesia. In both studies,granisetron (1 mg) was significantly more effective (P < .001) than placeboin preventing postoperative nausea and vomiting.

Postoperative Treatment

As treatment of postoperative nausea and vomiting, granisetron was evaluatedin two randomized, double-blind, placebo-controlled studies in adult surgicalpatients who received general anesthesia and no prophylactic antiemetictreatment, and who experienced nausea and vomiting within 4 hours after surgery.In one study, patients between the ages of 18 and 86 years received a singleintravenous dose of granisetron (0.1 mg, 1 mg, or 3 mg) or placebo afterexperiencing postoperative vomiting or severe nausea. The study showed thatgranisetron at all three doses was significantly more effective (P < .001)than placebo in preventing further episodes of nausea and vomiting. Moreover,the study demonstrated the agent’s efficacy when administered at intervals of0 to 6 hours and 0 to 24 hours.

The recommended dose of granisetron is 1 mg. The most common adverse eventsreported in the trials included pain, headache, and fever.

"The results of these studies are important because there is a need foralternative therapies for postoperative nausea and vomiting," said T. J.Gan, md, associate professor and director of clinical research, department ofanesthesiology, Duke University Medical Center. Dr. Gan said further thatpatients who fail treatment with other antiemetics are subjected to extended andunnecessary periods of nausea and vomiting, which can be severe anddebilitating. These patients may be successfully managed with granisetron.