Metoclopramide Pregnancy and Breastfeeding Warnings
Metoclopramide Pregnancy Warnings
Metoclopramide has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. However, metoclopramide has been used during pregnancy for its antiemetic and gastric prokinetic effects. Metoclopramide is only recommended for use during pregnancy when benefit outweighs risk.
Metoclopramide rapidly crosses the placenta near term. Fetal plasma concentrations are approximately 60% to 70% of maternal serum concentrations. While administration of metoclopramide at term is associated with significant increases in maternal serum prolactin levels, no changes were noted in cord arterial or venous plasma prolactin levels. In addition, metoclopramide does not affect maternal plasma TSH or estradiol levels. A case of acute porphyria in a female patient treated for hyperemesis gravidarum with metoclopramide in the 10th, 12th, and 18th week of pregnancy is reported in the literature. A normal infant was delivered at term. Data on the safety and efficacy of metoclopramide during pregnancy are primarily limited to the last trimester. More data are needed to evaluate safety in the first and second trimesters. Until then, the use of metoclopramide should typically be limited to the management of severe nausea and vomiting in the last trimester and to decrease gastric emptying time in the prevention of Mendelson's syndrome during labor and delivery. Data collected by five teratogenic information centers on women (n=126) that had taken metoclopramide (range, 10 to 40 mg) for nausea and vomiting during the first trimester of pregnancy (range duration of therapy, 1 to 35 days) suggests that the administration of metoclopramide during the first trimester of pregnancy is probably not associated with an increased risk of fetal malformations, decreased birth weight, or spontaneous abortions.
Metoclopramide Breastfeeding Warnings
In one study involving 23 women, metoclopramide milk concentrations ranged from 20 to 157 ng/mL following the oral administration of metoclopramide 10 mg three times a day for two weeks. Milk concentrations were consistently higher than corresponding serum concentrations. The estimated maximum exposure of the infant ranged from 6 to 24 mcg/kg/day in the early puerperium and from 1 to 13 mcg/kg/day in the late puerperium. Metoclopramide was detected in the serum of only one infant. In four of seven infants studied, plasma prolactin levels were elevated during maternal metoclopramide treatment compared to prolactin levels of control infants. Plasma thyrotropin concentrations in the infants were unaffected. In another study, infant serum prolactin, TSH, and free thyroxine concentrations were unaffected by maternal metoclopramide therapy (10 mg three times a day for 3 weeks).
Metoclopramide is excreted into human milk. The American Academy of Pediatrics considers metoclopramide use during lactation to be of concern, citing the potent nervous system effects of the drug. The manufacturer recommends caution.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.