Can Ondansetron (Ondan) and Pantoprazole (Pantop) injections be given during pregnancy?

From the Guidelines

Ondan (ondansetron) and Pantop (pantoprazole) injections can be used during pregnancy, but with caution and only when clearly necessary, as recommended by the most recent guidelines 1.

Key Considerations

• Ondansetron is classified as pregnancy category B, meaning animal studies show no risk but human studies are limited, and may be considered for severe pregnancy-related nausea and vomiting when other treatments have failed.
• The typical dose of ondansetron is 4-8 mg IV/IM every 8-12 hours as needed.
• Pantoprazole injection is pregnancy category C, indicating potential risks, and should only be used when the benefits clearly outweigh potential risks.
• Both medications should be prescribed by a healthcare provider who is aware of the pregnancy.
• Alternative treatments with better established safety profiles during pregnancy should be considered first, especially during the first trimester when organ development occurs.

Safety Concerns

• These medications cross the placenta and could potentially affect fetal development.
• Ondansetron use in pregnancy has been associated with an increased rate of orofacial clefting, but the absolute risk is small, increasing from 11 cases per 10,000 births to 14 cases per 10,000 births 1.
• The European Association for the Study of the Liver Clinical Practice Guidelines recommend ondansetron as a second-line therapy for hyperemesis gravidarum, and pantoprazole is not specifically mentioned as a recommended treatment for this condition 1.

Recommendations

• Always consult with an obstetrician before using these medications during pregnancy to ensure proper risk-benefit assessment.
• Consider alternative treatments with better established safety profiles during pregnancy, such as doxylamine and pyridoxine, which are recommended as first-line pharmacologic treatment of hyperemesis gravidarum 1.
• Use the lowest effective dose and monitor for potential side effects, such as drug-induced extrapyramidal symptoms and oculogyric crises, which can occur with the use of phenothiazines and metoclopramide 1.

From the FDA Drug Label

Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy Available postmarketing data have not identified a drug associated risk of miscarriage or adverse maternal outcomes. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area (BSA), respectively

Ondansetron use in pregnancy: The FDA drug label does not provide conclusive evidence regarding the safety of ondansetron use in pregnancy due to inconsistent findings and methodological limitations in epidemiological studies. However, available postmarketing data and reproductive studies in animals have not identified significant risks.

• Key points:
  • Inconsistent findings in epidemiological studies
  • No significant risks identified in postmarketing data and animal studies
  • Methodological limitations preclude conclusions about safety
• Clinical decision: Ondansetron may be used in pregnancy if the benefits outweigh the potential risks, but caution is advised due to the lack of conclusive evidence. 2 2

From the Research

Ondan and Pantop Injection in Pregnancy

• The provided studies focus on the use of ondansetron during pregnancy, with no direct mention of "pantop injection" [ 3, 4, 5, 6, 7 ].
• However, ondansetron is a medication used to treat nausea and vomiting, which can be relevant to pregnancy [ 3, 4, 5, 6 ].
• Studies suggest that ondansetron may be a useful and safe alternative for treating nausea and vomiting during pregnancy, with no significant increase in birth defects or adverse pregnancy outcomes [ 3, 4, 5 ].
• One study found that ondansetron was increasingly used off-label to treat nausea and vomiting during pregnancy, including in the first trimester [ 6 ].
• Another study compared the efficacy of ondansetron, metoclopramide, and placebo for adults with undifferentiated emergency department nausea and vomiting, but did not specifically focus on pregnancy [ 7 ].

Safety of Ondansetron in Pregnancy

• The available data suggest that ondansetron has not been associated with a significantly increased risk of birth defects or other adverse pregnancy outcomes [ 3, 4, 5 ].
• However, the studies also highlight the need for further research to establish the safety of ondansetron treatment during pregnancy [ 3, 4, 5 ].
• The American College of Obstetricians and Gynecologists recommends early treatment of nausea and vomiting of pregnancy to stop progression to hyperemesis gravidarum [ 4 ].

Use of Ondansetron in Pregnancy

• Ondansetron is widely administered to treat nausea and vomiting of pregnancy [ 5, 6 ].
• The most common oral daily dosages of ondansetron used during pregnancy were 4 mg/d, 8 mg/d, 12 mg/d, and between 16 and 24 mg/d [ 6 ].
• Prescription of ondansetron was initiated during the first trimester of pregnancy in 40% of the cases [ 6 ].