Metoclopramide Safety During Pregnancy
Metoclopramide is considered safe to use during pregnancy and is commonly prescribed for nausea and vomiting of pregnancy at doses of 5-10 mg orally every 6-8 hours. 1
Safety Profile
A meta-analysis of six cohort studies including 33,000 first-trimester women who used metoclopramide and over 37,000 controls found no significant increased risk of major congenital defects (odds ratio 1.14,99% CI 0.93-1.38) 1
A large register-based cohort study in Denmark (1997-2011) examining 28,486 women exposed to metoclopramide in the first trimester found no significant associations between metoclopramide use and major congenital malformations overall or any of 20 individual malformation categories 2
Metoclopramide has not been associated with increased risk of spontaneous abortion or stillbirth compared to unexposed women 2
It is commonly used for treatment of nausea and vomiting in pregnancy, including hyperemesis gravidarum, with established safety data 3, 4
Dosing and Administration
Standard dosing is 5-10 mg orally every 6-8 hours as needed for nausea and vomiting 1
Intravenous doses should be administered by slow bolus injection over at least 3 minutes to minimize the risk of extrapyramidal effects 3
Placement in Treatment Algorithm
According to some guidelines, metoclopramide is recommended as a second-line therapy after first-line options like anti-histamines, phenothiazines, and doxylamine/pyridoxine combinations 3
Other guidelines consider it safe for first-line use in pregnancy for nausea and vomiting 1
It can be used alone or in combination with other antiemetics when a single agent is ineffective 3
Potential Side Effects and Precautions
The primary concern with metoclopramide is the risk of extrapyramidal effects, which is why some guidelines recommend it as a second-line therapy 3
Patients should be monitored for adverse reactions, and the medication should be promptly discontinued if such reactions occur 3
The FDA label notes that common side effects include restlessness, sleepiness, tiredness, dizziness, headache, and confusion 5
Comparative Safety with Other Antiemetics
Ondansetron is also considered safe during pregnancy but has been associated with a small absolute risk increase of orofacial clefts (0.03%) and ventricular septal defects (0.3%) when used in early pregnancy 1
Steroids (methylprednisolone or prednisolone) are also considered safe for use during pregnancy after 10 weeks gestation, but should be avoided before 10 weeks due to a potential increase in oral cleft incidence 1
In a randomized study comparing metoclopramide with promethazine for hospitalized hyperemesis gravidarum patients, both had similar efficacy, but metoclopramide had fewer side effects like drowsiness, dizziness, and dystonia 1
In conclusion, metoclopramide represents a safe and effective option for treating nausea and vomiting during pregnancy, with substantial evidence supporting its use without increased risk of congenital malformations or adverse pregnancy outcomes.