12-Dec-12 8:00 AM  CST

32mg Dose of Zofran Pulled From Drug Market

There is news on the recall front once again.  The 32mg dose of the anti-nausea drug Zofran (ondansetron) has been pulled from the drug market due to concerns about serious cardiac problems.  Pharmacy technicians should note that the 32mg dose is an IV single dose.  Earlier in June of this year, the FDA issued a warning that the 32mg dose be avoided due to continuous risk of QT interval prolongation as this can lead to torsades de pointes – a life threatening heart arrhythmia.

The FDA recently commented on the recall.  “FDA continues to recommend the intravenous regimen of 0.15mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting.  Oral dosing of ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting.  At this time, there is not enough information available for the FDA to recommend an alternative single IV dose regimen,” said the FDA in a recent statement.  

Hospital pharmacy technicians will find this information especially helpful and can pass on the valuable information to their pharmacist and fellow pharmacy technicians.  You may even want to post the notice in common work areas of the pharmacy to get the word out concerning the recall.  A full list of the associated recalled products can be found by going to the FDA’s web site at www.fda.gov/Drugs/DrugSafety/ucm330049.htm

1.  Frieden, Joyce.  “High Dose Zofran Pulled From Market.”  FDA.  Web. 4 Dec 2012. 

2.  “Ondansetron (Zofran) 32mg, Single Intravenous (IV) Dose:  Undated Safety Communication – Product Removal Due To Potential For Serious Cardiac Risks.” Drugs.com.  4 Dec 2012. 

3.  “FDA Drug Safety Communication:  Updated Information On 32mg Intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products.”  FDA.  Web.  4 Dec 2012.    

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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