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FDA Approves Kytril for Postoperative Nausea and Vomiting

FDA Approves Kytril for Postoperative Nausea and Vomiting

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.

Postoperative Prevention

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

Postoperative Treatment

As treatment of postoperative nausea and vomiting, granisetron was evaluated in two randomized, double-blind, placebo-controlled studies in adult surgical patients who received general anesthesia and no prophylactic antiemetic treatment, 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 single intravenous dose of granisetron (0.1 mg, 1 mg, or 3 mg) or placebo after experiencing postoperative vomiting or severe nausea. The study showed that granisetron 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 of 0 to 6 hours and 0 to 24 hours.

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

"The results of these studies are important because 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 said further that patients who fail treatment with other antiemetics are subjected to extended and unnecessary periods of nausea and vomiting, which can be severe and debilitating. These patients may be successfully managed with granisetron.

 
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