Metoclopramide Pregnancy and Breastfeeding Warnings
Metoclopramide Pregnancy Warnings
Benefit should outweigh risk. AU TGA pregnancy category: A US FDA pregnancy category: B
-Reproduction studies performed in animals by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to this drug. There are no adequate and well-controlled studies in pregnant women; however, this drug has been used during pregnancy for its antiemetic and gastric prokinetic effects. -While administration of this drug at term is associated with significant increases in maternal serum prolactin levels, no changes were noted in cord arterial or venous plasma prolactin levels nor does it affect maternal plasma TSH or estradiol levels. -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 5 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. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Metoclopramide Breastfeeding Warnings
-This drug is excreted in variable amounts in breast milk. Most infants would receive less than 10% of the maternal weight-adjusted dosage, but some receive doses that achieve pharmacologically active serum levels, elevated serum prolactin and possible gastrointestinal side effects. -This drug is used as a galactagogue, but its clinical value in increasing milk supply is questionable. -Postpartum mothers are at a relatively high risk for postpartum depression and this drug can cause depression as a side effect. Therefore, therapy should probably be avoided in women with a history of major depression and not used for prolonged periods in any mothers during this time of high susceptibility.
AU: Safety has not been established. UK: Not recommended. US: Caution is recommended. The American Academy of Pediatrics considers using this drug during lactation to be of concern, citing the potent nervous system effects of the drug. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown.
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