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Metoclopramide Pregnancy and Breastfeeding Warnings

Metoclopramide is also known as: Maxolon, Metozolv ODT, Reglan

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.

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