Zofran (Ondansetron) – Case Review – Focus Blocks

Zofran is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation). It is in a class of drugs known as 5-HT3 receptor antagonists that work by blocking the action of Serotonin that causes vomiting.

Zofran is used off-label to treat morning sickness and hyperemesis gravidarum of pregnancy.

FDA Warning:

The FDA has issued an updated warning against Ondansetron, better known by its brand name, Zofran. Based on recent studies regarding the association between Zofran use in early pregnancy (First trimester) and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. Zofran is only recommended for use during pregnancy when the benefit outweighs the risk.

Zofran Recalls:

The FDA recalled Zofran in September 2011 because of the medication’s possible effects on pregnant women. This recall made it mandatory for pharmacies to inform patients about the risk of birth defects and cardiovascular abnormalities. It also advised doctors to lower the dosages they provide to pregnant women and to limit intravenous doses to 0.15 mg per four-hour interval.

In December 2012, the FDA announced another Zofran recall that stayed in effect until GlaxoSmithKline updated labels with information about possible changes to QT intervals. New side effects include irregular heartbeat, dizziness, fainting, shortness of breath, and electrolyte abnormalities. The FDA also issued alerts to health care professionals, instructing doctors to report such side effects directly to them, and to avoid prescribing Zofran to patients who already have irregular heartbeats.

Case Review Focus Areas:

  • Whether the patient was prescribed Zofran? Reason for prescription? (To prevent nausea and vomiting caused by surgery and medicines or off-label use – Pregnancy)

  • Did the patient have any preexisting conditions, allergies or contraindications for Zofran? (eg Congenital long QT syndrome)

  • Dosage and Intake details including duration of Zofran use (to be included under pharmacy log). Critical Review of

  • Physician Drug Prescription Details

  • Pharmacy Dispensing Details

  • Pharmacy Refill Details

  • Details of Pharmacy Dispensing Details are taken as Confirmatory 

  • What was the injury due to Zofran? (Cleft palate, Cleft lip, congenital heart defects which can lead to life-threatening cardiovascular conditions)?

  • When was the injury diagnosed?

  • Treatment/management (Reconstructive surgery). Any complications

  • Follow-up visits for treatment/management of injury/Additional surgeries

  • Outcome/prognosis

  • Medical History

Specific Focus

Identify and report cases with the following scenarios:-

  • No Injuries: Patient took Zofran but did not develop any injuries

  • No Zofran intake: The patient was given a different drug and not Zofran. Hold case and communicate to the client.

  • Zofran contraindicated inpatient but still prescribed

Missing Record Communication:

Identify and report on missing medical records/pharmacy bills

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable? This will also help in following up and retrieving the records.

Submit Case

If you have a case to be reviewed and summarized, please reach out to us at 610-674-6901 or email us at [email protected]

Published On: February 22, 2021 / Categories: Dangerous Drugs /