FDA: Label change for single IV dose of ondansetron
FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
Ondansetron, a 5-HT3 receptor antagonist, is used to prevent nausea and vomiting associated with cancer chemotherapy, radiation therapy, and surgery.
The safety announcement follows the release of preliminary results from a recently completed manufacturer-conducted clinical study. As part of the ongoing safety review of ondansetron, GlaxoSmithKline (GSK) was required by FDA to assess the potential for the drug to prolong the QT interval.
The 32-mg single intravenous dose will be removed from the Zofran drug label, which will state that no single intravenous dose should exceed 16 mg. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0.15 mg/kg administered every 4 hours for 3 doses.
FDA says it will evaluate the final study results when complete, and will continue to work with GSK to explore a safe alternative single dose regimen. Meanwhile, the agency notes that adverse events should be reported to the FDA MedWatch program.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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