Is Maxalon (Metoclopramide) safe during pregnancy?

From the Guidelines

Maxalon (metoclopramide) is considered safe for use during pregnancy when medically necessary, with a meta-analysis of six cohort studies showing no significant increase in the risk of major congenital defects 1.

Key Points to Consider

• The use of metoclopramide in pregnancy is supported by a study published in the Annals of Oncology, which found that the risk of major congenital defects was not significantly increased with its use 1.
• The American College of Gastroenterology recommends a step-up approach for managing hyperemesis gravidarum, with metoclopramide being considered for patients who do not respond to first-line therapy 1.
• The typical dosage of metoclopramide is 5-10 mg orally, every 6-8 hours, as commonly used by pregnant women to treat nausea and vomiting of pregnancy 1.
• Potential side effects of metoclopramide include drowsiness, restlessness, and rarely, extrapyramidal symptoms.
• Non-pharmacological approaches to managing nausea, such as small frequent meals and ginger, should be tried first before resorting to medication.

Important Considerations

• Metoclopramide should only be used when the benefits outweigh potential risks, and under medical supervision.
• The use of other medications, such as ondansetron, should be considered on a case-by-case basis, particularly in patients with severe symptoms or those who do not respond to metoclopramide 1.
• Methylprednisolone may be considered as a last resort in patients with severe hyperemesis gravidarum, but its administration in the first trimester should be done with caution due to the potential risk of cleft palate 1.

From the FDA Drug Label

You are pregnant or plan to become pregnant. It is not known if metoclopramide will harm your unborn child. The FDA drug label does not answer the question about Maxalon (metoclopramide) being safe in pregnancy, as it only states that it is not known if metoclopramide will harm the unborn child.

From the Research

Safety of Maxalon in Pregnancy

There is no direct information available on the safety of Maxalon in pregnancy. However, Maxalon is another name for Metoclopramide, which has been studied in the context of pregnancy.

Metoclopramide Studies

• A study published in 2013 2 found that Metoclopramide use in pregnancy was not associated with an increased risk of major congenital malformations, spontaneous abortion, or stillbirth.
• Another study published in 2016 3 compared various treatments for nausea and vomiting in pregnancy, including Metoclopramide, and found that it was associated with improved symptoms compared to placebo.
• A study published in 2019 4 discussed the management of acute-onset, severe hypertension during pregnancy and the postpartum period, but did not mention Metoclopramide or Maxalon.
• A study published in 2014 5 compared the efficacy of Ondansetron, Metoclopramide, and placebo for adults with undifferentiated emergency department nausea and vomiting, and found that Metoclopramide was effective in reducing nausea severity.

Key Findings

• Metoclopramide is not associated with an increased risk of major congenital malformations, spontaneous abortion, or stillbirth 2.
• Metoclopramide is effective in reducing nausea and vomiting in pregnancy 3, 5.
• There is no direct information available on the safety of Maxalon in pregnancy, but the available data on Metoclopramide suggests that it may be safe to use during pregnancy.