Prochlorperazine Pregnancy and Breastfeeding Warnings
Prochlorperazine Pregnancy Warnings
Two infants who were exposed to prochlorperazine during the first 12 weeks of gestation for the treatment of hyperemesis gravidarum were born with limb amputations (one below elbow and one below knee) with a rudimentary hand or foot. Another similar report describes an infant with hypoplasia of the radium and ulnar bones with a vestigial wrist and hand. The infant had been exposed to prochlorperazine during the first trimester. In a review of 50,282 mother-child pairs, 877 were exposed to prochlorperazine during the first trimester. Forty seven birth defects were reported in this group (41.2 expected) for a standardized relative risk of 1.14. When classes of malformations were analyzed, a relative risk of 1.85 accompanied cardiovascular defects, 1.59 accompanied genitourinary defects, and 2.38 accompanied Downs syndrome. In a review of 229,101 deliveries to Michigan Medicaid patients, 704 first-trimester exposures to prochlorperazine and 1486 exposures any time during pregnancy were recorded. A total of 24 birth defects were reported with first trimester exposure (29 expected) and included (observed/expected) 6/7 cardiovascular defects, one oral cleft, one polydactyly, and one limb reduction defect (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). These data do not support an association between prochlorperazine and birth defects. A prospective survey of 12,764 mothers revealed 189 infants with birth defects not chromosomally based. Phenothiazines were ingested by 315 of these women during the first trimester and 11 gave birth to malformed infants, at a significantly higher rate than those not receiving phenothiazines. Forty eight mothers received piperazine side chain phenothiazines (which include prochlorperazine). None of these women gave birth to malformed infants. Another prospective survey of antinauseant use during the first 84 days of pregnancy in 10,205 women recorded 543 exposures to prochlorperazine. The rate of congenital anomalies was 1.8, 2.9, and 4.1 at 1 month, 1 year, and 5 years of age, respectively. The rate for women with nausea and vomiting who did not receive drugs was 1.5, 2.2, and 3.7, respectively. This difference was not statistically significant.
Prochlorperazine has not been formally assigned to a pregnancy category by the FDA. Several retrospective and prospective surveys have suggested that there is no increased risk of congenital malformations in humans with use of prochlorperazine in pregnancy. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Prochlorperazine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
Prochlorperazine Breastfeeding Warnings
There are no data on the excretion of prochlorperazine into human milk. Other phenothiazines have been found in human milk. There are no published reports of adverse effects associated with the use of prochlorperazine during breast-feeding.
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