Results of a clinical trial showed that the 32 mg dose of the anti-nausea drug ondansetron (Zofran) could affect a patient’s heart. FDA and GlaxoSmithKline have placed warnings on the drug, saying that intravenous doses of the drug should not exceed 16 mg.
This is not the first time Zofran has been in the news. In September, FDA announced that it launched a safety review of the anti-nausea drug after the agency received word that the drug may affect the electrical activity of the heart.
On June 29, FDA put out an advisory for ondansetron (Zofran, ondansetron hydrochloride and generics) after it found that the drug could affect the electrical activity of the heart (QT prolongation), a possibly fatal heart rhythm called Torsades de Pointes.
The drug’s maker said that it has updated the drug’s level to remove the single intravenous dose. However, a dose of 0.15 mg/kg can continue to be used in adults, FDA said. The drug company said that no intravenous dose of the drug should exceed 16 mg.
Patients with congestive heart failure, congenital long QT syndrome, bradyarrhythmias and those taking concomitant medications that prolong QT intervals are most at risk. The drug is administered to patients who suffer from nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.
FDA said that the clinical trial results will be included on the drug’s label. Additionally, the agency said that it will work with GlaxoSmithKline to explore an alternative single dose of the drug that is safe and effective for these patients undergoing treatments.
FDA has urged patients and physicians to report adverse events to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.