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No adverse effects of drug exposure, including bradycardia, were noted in the newborn, which was growing normally at 1 year of age (11). Moreover, ofatumumab crossed to the fetus in monkeys and, because the placentas in monkeys are similar to those in humans, the antibody should be expected to cross to the human fetus. In contrast, ibuprofen prenatal exposure was not associated with adverse neurodevelopment outcomes (22). There is also controversy on whether the 1981 study should have been published (4,5). In an experiment with stressed (noise and light at unpredictable frequency) pregnant rats, a continuous infusion of naltrexone (10 mg/kg/day) was administered by implanted minipumps from day 17 of gestation (4). Compared to the placebo group (N = 36), the pregnancy outcomes of the active drug group (N = 44) included significantly fewer admissions for preterm labor (27% vs. Similar, nonsignificant differences for each of the categories were also found in the breast reduction group. Long-term follow-up of 25 children exposed in utero to carbimazole showed normal growth and development (15). The woman was started on levodopa (200 mg/day) and pergolide (3 mg/day) about 3 years before conception. The animal reproductive data suggest low risk, but the absence of human pregnancy experience prevents a complete assessment of the embryo­fetal risk. The woman had been treated with chloroquine, 100 mg/day, plus a combination of dapsone (100 mg) and pyrimethamine (12. The study was limited to children under the age of 5 years to minimize the loss to out-ofstate migration (expected to be no more than 6% (12)). Because of the positive carcinogenic tests and the potential for suppression of gastric acid secretion in the nursing infant, the use of rabeprazole during lactation should probably be avoided until clinical data are available. Sedation is a frequent adverse effect in adults treated with olanzapine and has occurred in nursing infants whose mothers were taking the drug. Three children with any malformation were observed in the total group, but only 1 had a malformation considered easily recognizable among the 12 medical centers participating in the study. A second large prospective study covering 613 1st trimester exposures supported these negative findings (30). Shift work, nitrous oxide exposure, and spontaneous abortion among Swedish midwives. However, one of these children was not exposed until after the critical period for limb development (3). The drug was not genotoxic in multiple assays, but it induced numerical chromosomal aberrations in cultured newborn Chinese hamster lung fibroblasts. Using methods and a patient population nearly identical with those of their previous study, the investigators found that a 1000-mg oral dose of levodopa produced a significant decrease in serum prolactin, plasma renin activity, and plasma aldosterone. In humans, iron-deficiency anemia may significantly enhance the chance for a low-birth-weight infant and preterm delivery (4,5). Serum lysine levels, which were regularly >10 mg/dL and may have been as high as 20 mg/dL or more when the disorder was detected, were not measured during the pregnancy or in the baby. Plasma protein binding is about 15% or less and the elimination half-life is about 8 hours (1). Based on calculations from a 1984 study, a mother ingesting 200 mg/day of metoprolol would provide only about 225 mcg in 1000 mL of her milk (3). Syndactyly of the right hand with shortened fingers and talipes equinovarus of the left foot were also present. The infant was doing well at 15 months of age with no evidence of neurologic, renal, growth, or hematologic effects from the exposure (7). No congenital abnormalities were observed in the infants exposed to the drug combination. Autopsy revealed severe tubular dysgenesis and the renal arteries and arteriole walls were thickened (2). The elimination half-life is in the range of 6­17 hours, but may be prolonged after chronic administration (1).

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A 2006 review of prophylactic therapy of bipolar disorder briefly described the effects in pregnancy and breastfeeding of a number of drugs, including olanzapine (17). Propranolol, esmolol, and sotalol were ineffective and could not be continued due to hypotension. If so, the authors suggested, it might be beneficial for formula-fed infants if insulin was added to formula milk (7). A male infant was born 9 weeks prematurely and was found to be blind in the right eye, and to have cerebral palsy with left-sided spasticity. However, a causal relationship between breast implants and connective-tissue and autoimmune disease seems unlikely based on the results of a meta-analysis described below. Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial. No pregnancy complications were reported with the free use of raspberry leaf tea in late pregnancy. She was also taking metformin (1 g/day) for polycystic ovarian syndrome with oligomenorrhea. In one report, a breastfeeding mother used povidone-iodine vaginal gel daily for 6 days without douching (10). This latter conclusion has been challenged (2,3) and defended (4) and it requires additional study. A 1995 report described the use of sertraline 100 mg/day and nortriptyline 125 mg/day in a woman with recurrent major depression (6). Other toxicities were noted in the embryos and fetuses of mice, rats, and rabbits at doses 3. In contrast, a 1992 study, comparing the effects of pindolol and propranolol in women with preeclampsia, found a significant reduction in uterine artery vascular resistance, prompting the authors to conclude that pindolol acted, at least in part, through a peripheral vascular mechanism (12). The newborns from the mothers given 2 mg/kg, but not those exposed to lower doses, had profound respiratory depression. Shepard (10) reviewed 15 studies that evaluated the reproductive effects of pyrimethamine in rats, mice, and hamsters. The authors, however, did not believe that measurement of the higher drug levels would have changed their conclusion (5). A possible interaction between cocaine abuse and indomethacin resulting in fetal anuria, generalized massive edema, and neonatal gastrointestinal hemorrhage has been reported (70). A randomly selected control group (N = 267) was formed comprising women who had exposures to nonteratogenic agents. Review of 1157 hypertensive pregnancies demonstrated no adverse effects from methyldopa administration (9­21). Pentostatin was mutagenic in some assays but not others, and was clastogenic in one test. A Swedish investigation measured higher levels of T3 in milk 1­3 months after delivery as compared with T3 levels in early colostrum (19). A 2001 study, using a treatment method similar to the above study, described the use of droperidol and diphenhydramine in 28 women hospitalized for hyperemesis gravidarum (22). Representatives of the American Psychiatric Association and the American College of Obstetricians and Gynecologists issued a joint statement on the management of depression during pregnancy in 2009 (60). Abnormal genitalia as a presenting sign in two male infants with hydantoin embryopathy syndrome. Neither carcinogenicity nor fertility studies have been conducted with pralatrexate. The use of antipsychotics, including pimozide, close to delivery may cause extrapyramidal effects (Parkinsonlike symptoms; akinesia) in the newborn (1). A number of study limitations were discussed, such as missing data from charts that could not be assessed and the inability to document actual consumption of the antidepressants. Exogenous potassium chloride may be indicated as replacement therapy for pregnant women with low serum potassium levels, such as those receiving diuretics. The three major anomalies in the leflunomide-exposed infants were occult spinal dysraphism, unilateral uretero pelvic junction obstruction and multicystic kidney disease, and microcephaly. Moreover, the drug is available as an ophthalmic solution and such use has not resulted in detectable levels in the plasma.

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No increase in nongenital malformations was noted at any dose, but the two highest doses caused embryotoxicity (resorptions and decreased weight). Her dosage had been increased during an interval of 6 days in a manner described above, producing serum quinidine levels of 1. A brief 1970 review summarized the history, dosage, effects, and adverse effects of mescaline (8). In addition to the 61 sertraline cases, the other cases were 113 bupropion, 184 citalopram, 21 escitalopram, 61 fluoxetine, 52 fluvoxamine, 68 mirtazapine, 39 nefazodone, 148 paroxetine, 17 trazodone, and 154 venlafaxine. The uterus relaxed palpably within 20 seconds and the fetus was repositioned to allow for vaginal delivery. The Collaborative Perinatal Project monitored 50,282 mother­child pairs, 1249 of whom had 1st trimester exposure to phenylephrine (4, pp. Moreover, long-term effects on neurobehavior and development are unknown but warrant study. An estimation of this risk, based on a pharmacokinetic model, was published in 1994 (11). All milk risperidone concentrations were <1 mcg/L, whereas the mean concentration of the metabolite was 5. A woman taking 600 mg every 8 hours had milk and serum concentrations determined on the 5th postpartum day, 3 hours after a dose. Plasma protein binding is minimal (about 2%) and the elimination half-life is about 1 hour (1). Neonatal hemorrhage secondary to thrombocytopenia: an occasional effect of prenatal hydantoin exposure. Levels were significantly higher in 12 patients in early labor than in 8 women undergoing elective cesarean section. The specific malformations involved the external ear, facial anomalies, including cleft lip/palate, and anomalies of the distal limbs, heart, esophagus, and kidney (17). The effects of this exposure on a nursing infant are unknown, but a similar agent, piroxicam, is classified as compatible with breastfeeding by the American Academy of Pediatrics (see Piroxicam). A woman with Zollinger-Ellison syndrome was treated in two of her three pregnancies with omeprazole (5). If breastfeeding is desired, the lowest dose of oral contraceptives should be chosen. The women were randomized to receive either the cardioselective -blocker, atenolol (N = 13), or the nonselective blocker, pindolol (N = 16). These changes were associated with a decrease in fetal placental blood flow and an increase in fetal vascular resistance, and five fetuses died 65 minutes after nicardipine was given. The molecular weight (about 318 for the free acid), prolonged elimination half-life (up to 157 hours), and lack of metabolism suggest that active drug will be excreted into breast milk. In nine women treated with propranolol for gestational hypertension, three delivered prematurely. The other four (all from retrospective reports) were: no left hand, left radius and cubitus were incomplete; hypoplasia of distal phalanx of the thumb; missing or hypoplastic fingers, camptodactyly, and syndactyly; and reduction defect of left arm. The role of the injection-delivery time interval and the plasma concentrations of pethidine and norpethidine. Embryotoxic effects (not specified) were observed when a smaller dose (18 mg/m2) was administered over the same period. A 2000 case report published in France described hemolytic anemia in a full-term newborn whose mother had taken nitrofurantoin during the last month of pregnancy (10). A defect of the aortic valve (bicuspid with a notch in one of the valve leaflets) was also found. Saxagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. In addition, various assays have found no evidence of mutagenesis when nontoxic doses were used. The mother had also taken tetracycline and a decongestant for a cold during the 1st trimester. Macrophage activation was suggested from the results of a case­control study of 38 breastfed children from mothers with silicone breast implants compared with 30 controls (healthy children N = 10, children with gastrointestinal symptoms similar to study patients N = 10, children with benign urinary abnormalities N = 7, and children with joint symptoms similar to study patients N = 3) (26). The second case also involved a woman with the same disorder who took iodoquinol throughout gestation (2). In addition, increased incidences of cleft palate were observed with this dose on several days between gestational days 1 and 12 (4).

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Milk samples were collected from 12 women after a sertraline dose at 4­6 hours for 24 hours (35). The contraindications to the use of podophyllum agents include the use of podophyllotoxin (podofilox) during pregnancy and in the vagina or cervix at any time (2). Breast milk samples were collected before (to measure endogenous interferon alfa) and after the infusion. Oral administration of pyridoxine hydrochloride in the treatment of nausea and vomiting of pregnancy. No cases of true oligohydramnios were observed, although 3 cases of low-normal fluid occurred that resolved after discontinuation of ibuprofen. Depressed respirations (23 breaths/minute), slowed heart rate (112 beats/minute), and hypothermia (96. During 48 hours, the mean amounts of loratadine and metabolite recovered from the milk were 4. When peyote is used according to recommendations of the Native American Church, the risk for developmental toxicity was not thought to be increased. The low molecular weight (about 159), minimal metabolism, lack of plasma protein binding, and the moderately long elimination half-life suggest that the drug will reach the embryo and fetus. Cholestyramine was definitely used in two pregnancies and may have been used in all (5). Monitoring of infant weight gain and the possible need for nutritional supplementation should be considered (see Oral Contraceptives). In addition, the use of any opioid agonist during labor or close to delivery may cause neonatal respiratory depression. Because a linear relationship between lithium and toxicity was assumed, these exposures, which produce concentrations of lithium well below therapeutic levels, were not thought to produce human toxicity (47). Naloxone has also been safely given to newborns within a few minutes of delivery (8­13). Maternal use of selective serotonin reuptake inhibitors and risk of congenital malformations. One manufacturer has reports of 1st trimester mebendazole exposure in 170 pregnancies going to term without an identifiable teratogenic risk (4). Intelligence scores of Danish adult men, born between 1959 and 1961, who had been exposed to prenatal phenobarbital were measured. Animal reproduction studies in mice and rats at doses up to 4 times the human dose have shown no evidence of impaired fertility or fetal harm (1). A 1999 report described the outcomes of pregnancies in 20 women with breast cancer who were treated with antineoplastic agents (24). Review of all birth defects from prospective and retrospective reports revealed no signal or consistent pattern to suggest a common cause (4). In the second part of this study, the cause of the embryotoxicity was found to be directly related to a decrease in placentalderived progesterone production (6). It is used in oral contraceptives and hormonal pregnancy tests (no longer available in the United States). Chronic exposure to the opioid antagonist naltrexone during pregnancy: maternal and offspring effects. Losartan was stopped and an amnioinfusion was given, but the woman developed signs of infection and a hypotonic male infant (weight not given) was delivered. The use of phytonadione (vitamin K1) during pregnancy and in the newborn has been the subject of several large reviews (3­6). Two of the reported cases of nephrogenic diabetes insipidus persisted for 2 months or longer (6,34). No such effects have been observed in monkey neonates exposed in utero to indinavir during the 3rd trimester. Indications for use of opioid analgesics were surgical procedures (41%), infections (34%), chronic diseases (20%), and injuries (18%).

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There is probably no relationship of this toxicity in pregnant humans consuming occasional low (10 mg) doses, but high doses or frequent use during gestation should be avoided. The drug is not teratogenic in rats, hamsters, and rabbits, but embryotoxicity and fetotoxicity were observed in the latter species (1,2). Long-term studies of growth and mental development in offspring exposed to antineoplastic agents during the 2nd trimester, the period of neuroblast multiplication, have not been conducted (32­34). Early embryo lethality was observed in rabbits at doses close to those used in humans and above. A cesarean section was performed at week 37 to give birth to a healthy 3110-g neonate (sex not specified) with Apgar scores of 10 and 10 at 5 and 10 minutes, respectively. However, based solely on the limited human pregnancy experience, inadvertent exposure does not appear to represent a major risk to the embryo or fetus, but infants should be monitored for hypocalcemia during the first few days after birth. If the diet of the lactating woman adequately supplies this amount, maternal supplementation with pyridoxine is not required (82). Using a slightly different exposure protocol during rat pregnancy, these same investigators did observe subtle differences from controls in growth rates at 14 and 21 days and reduced reflex suspension, indicating that normal development had been interrupted (25). Long-term dosing resulted in discoloration of the testes and ovaries, hypertrophy of the testes, and decreased body weights (1). The only adverse effect observed was sedation in 8 women who received promethazine compared with none in the ondansetron group. An accompanying editorial discussed the strengths and weaknesses of the study (13). It is also used in combination with amoxicillin and/or clarithromycin for Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence. No significant changes (heart rate, mean arterial blood pressure, arterial blood pH, and arterial oxygenation) in the fetuses were observed. The low molecular weight (about 238), lipophilic nature, and long plasma half-life suggest that exposure of the embryo­fetus will occur. Her platelet count, which had been 172,000/microliter the night before, was now 4000. The highest dose disrupted parturition resulting in maternal and offspring death and morbidity. Successful pregnancy in a woman with acromegaly treated with somatostatin analog (octreotide) prior to surgical resection. A number of studies have reported normal Apgar scores, umbilical acid­base values, and neurobehavioral assessments when ropivacaine epidurals were used in women in labor (4­11). However, the authors recommended caution in interpreting these latter defects as causal associations. Acute resynchronization with inhaled iloprost in a pregnant woman with idiopathic pulmonary artery hypertension. Nitroglycerin has also been used to relax the uterus in postpartum cases with retained placenta (28­31), two of which occurred in patients with an inverted uterus (30,31). The low metabolism is similar to large proteins without a specific organ as a major route of elimination. Transposition of the great vessels in an infant exposed to massive doses of oral contraceptives. The prolonged adult elimination half-life and the potential for long-term neurodevelopment toxicity in a nursing infant should be considered before olanzapine is prescribed during lactation. Institute of Medicine and the Food and Nutrition Board have suggested an adequate intake of 1. A 38-year-old woman took lamotrigine throughout her third pregnancy for a seizure disorder caused by a pilocytic astrocytoma 6 years earlier (18). A 31-year-old white female with severe recurrent major depression took phenelzine 45 mg/day before and throughout her pregnancy (4). The overlap between the two groups, however, casts doubt on the physiologic significance of the differences. Although retrospective reports are considered to be biased, they are useful as early indicators of fetal risks if a cluster of defects or abnormalities is observed. Placental transfer of ritonavir with zidovudine in the ex vivo placental perfusion model. Attempts to taper her dose were unsuccessful and the patient declined to change to other depression therapy. In agreement, research has demonstrated the rapid uptake of isoflurane by the fetus (11).

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Marked hypotension (30­50 mmHg systolic) was present, which resolved after 24 hours. Other aspects of developmental toxicity could not be assessed because the tested doses caused maternal toxicity. Although human data have been published and no congenital malformations attributable to salmeterol were observed, the data are too limited to assess the safety of salmeterol. The data indicated that there was no substantial risk of adverse pregnancy outcome among leflunomide-treated women who undergo the cholestyramine elimination procedure early in pregnancy (10). The molecular weight (about 777) and elimination half-life (about 2 hours) suggest that limited amounts of the agent will be excreted into breast milk. The results of an autopsy confirmed that the cause of death was compression of the umbilical vein by the hematoma with subsequent umbilical venous thrombosis. Pheochromocytoma: antepartum diagnosis and management with tumor resection in the puerperium. Among these, exposure to monotherapy occurred in the following: phenytoin (N = 24), phenobarbital (N = 65), mephobarbital (N = 10), carbamazepine (N = 46), valproic acid (N = 80), and other agents (N = 16). In agreement with the molecular weight (about 252) of the parent drug, oxcarbazepine and its metabolite have been found in the fetus (2,6). The molecular weight (about 383) is low enough that passage to the fetus should be expected. None of the study cases had a history of therapeutic radiation or exposure to chemotherapy before their cancer diagnosis. The use of procainamide during human pregnancy has not been associated with congenital anomalies or other adverse fetal effects (1­9). Although the woman was not nursing, the absolute and relative infant doses were 0. It is indicated for the treatment of hypertension that is symptomatic or associated with target organ damage. No reports associating oxymetazoline with congenital abnormalities have been located. Effect of gestational sex steroid exposure on limb development and endochondral ossification in the pregnant C57B1/6J mouse: I. No significant differences were found between the implant-exposed breastfed and bottle-fed subjects or between the total exposed group and controls (7 of the 17 were tested) in autoantibodies to eight antigens (nuclear, Sci-70, centromere, ribonucleoprotein, Sm, Ro, La, and phospholipid). Low systemic blood levels have been noted in some patients treated for spider or reticular veins (1). In other tests, palonosetron was not genotoxic but did have clastogenic effects (1). A few years later, now at age 34 and receiving levodopa/carbidopa 625 mg/day and cabergoline 4 mg/day, she became pregnant again. In addition, protein-bound serum iodine levels may be increased with the administration of iodoquinol and may persist for as long as 6 months after discontinuation of therapy (4). However, a 1985 critique concluded that both sets of investigators had seriously biased their results by failing to adjust for potentially confounding variables (13). Maternal hypothyroidism itself has been reported to be responsible for poor pregnancy outcome (10). Reproductive toxicity testing of the oral agent in animals has not been conducted (1). The cause of the defects in the above infant is unknown, but drug-induced teratogenicity cannot be excluded as in utero exposure to both drugs occurred during organogenesis. The advisory cited evidence from two epidemiologic studies (2,3) that paroxetine use in the 1st trimester was associated with a 1. Except for the latter category, no firm evidence has appeared that establishes a causal relationship between oral contraceptives and various congenital anomalies. No carcinogenicity, mutagenicity, or impairment of fertility studies have been conducted (1). Phencyclidine use among youth: history, epidemiology, and acute and chronic intoxication. The animal data suggested risk (reduced fetal weights and late resorptions in two species) but these effects occurred with doses that were maternally toxic. An anaphylactic reaction in a pregnant patient reportedly led to the death of her fetus in utero (12). It is a quaternary amine that because of its restricted ability to cross the blood­brain barrier acts peripherally without affecting opioid-mediated analgesic effects in the central nervous system.

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It is indicated for the management of exogenous obesity as a shortterm adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The American Academy of Pediatrics classifies riboflavin as compatible with breastfeeding (25). These data suggested that the association between pseudoephedrine and the other drugs and gastroschisis may have been caused by an underlying maternal illness (3). Pregnancy outcome after in utero exposure to itraconnazole: a prospective cohort study. Ventilatory depression of the newborn of women receiving pethidine or pentazocine. Commenting on their results, the investigators thought that recall bias was unlikely because they did not observe increased risks for other malformations, and it was also unlikely that the mothers would have known of the suspected association between corticosteroids and orofacial clefts (15). The infant was lethargic and demonstrated an electroencephalographic pattern compatible with sedative medication (see Diazepam). In the prospective study, 187 outcomes (184 pregnancies, 3 sets of twins) exposed to prednisone were compared with the outcomes in 188 controls. Severe anuria and hypotension, resistant to both pressor agents and volume expansion, may occur in the newborn following in utero exposure to olmesartan. In a 2010 study, 199 children, who had been breastfed while their mothers were taking a single antiepileptic drug (carbamazepine, lamotrigine, phenytoin, or valproate), were evaluated at 3 years of age cognitive outcome (112). Mean naproxen levels in maternal serum, fetal tissue, coelomic fluid, and amniotic fluid were 69. Moreover, an antianalgesic effect, as evidenced by pain score, duration of analgesia, and an increased need for meperidine, was observed when promethazine was used. Pyridoxal phosphate in plasma and leukocytes of normal and pregnant subjects following B6 load tests. The Antiretroviral Pregnancy Registry has reported one 2nd/3rd trimester exposure to maraviroc. Behavioral outcomes in preschool and school-age children exposed prenatally to marijuana: a review and speculative interpretation. Panitumumab may cause severe, infusion-related toxicity, including hypotension and other adverse effects. Elevated alpha-fetoprotein in pregnancy complicated by aplasia cutis after exposure to methimazole. In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 3 newborns had been exposed to lovastatin during the 1st trimester (F. The case report below strongly suggests that olmesartan crosses the human placenta. New postmarketing surveillance data supports a lack of association between quinolone use in pregnancy and fetal and neonatal complications. Shepard (1) briefly reviewed a number of animal studies that found widespread nicotine-induced toxicity during pregnancy. Mitoxantrone accumulates in the plasma and tissue after multiple doses and is slowly eliminated from the body (1). Only very small amounts appear in the maternal circulation after epidural use and these concentrations would be cleared within 24 hours. The results were thought to be consistent with dopamine inhibition of oxytocin release. The investigators concluded that the findings suggested a possible modest increased occurrence of congenital defects compared with other antidepressants (25). A dietary and clinical survey of pregnant women with particular reference to toxaemia of pregnancy. A similar interaction occurred in another patient who was being treated with propranolol (13). Melatonin increases activities of glutathione peroxidase and, superoxide dismutase in fetal rat brain. Effects of single-dose administration of ifosfamide on testes and semen characteristics in the rabbit. Developmental toxicity (decreased pup survival) also was observed in a perinatal and postnatal rat study at doses producing exposures equal to or greater than about 0. In the second case, a woman received a 100-mcg bolus of nitroglycerin to quickly relax a contracted uterus and to allow the successful delivery of her twins (19). A Turkish woman had used ketoconazole, 200 mg daily, during the first 7 weeks of gestation.

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Indomethacin in the treatment of premature labor: effects on the fetal ductus arteriosus. At the time of the reports, one child had mild developmental retardation at 3 years of age (7). The placenta converts flavin adenine dinucleotide existing in the maternal serum to free riboflavin found in the fetal circulation (5,6). The reviewers concluded that little risk to the nursing infant was present if maternal levels were kept in the therapeutic range. Influence on the prothrombin time of breast-fed newborn babies of one single dose of vitamin K1 or Synkavit given to the mother within 2 hours after birth. Surgical correction of the defect was attempted within 4 days of birth in each of the cases, but one infant died of severe infection. Heel lanceinduced facial action increased in all three groups but was significantly lowered (blunted) in the first group. Jejunal atresia occurred in 17 (19%) of the pregnancies; in 15 of the affected cases, it was possible to determine that the affected fetus had been the one exposed to the dye. A 2003 study using data from three Swedish health registers (1995­2001) that included maternal drug history collected prospectively identified 1142 infants with orofacial clefts (isolated or with other malformations, excluding chromosome anomalies) (14). Benefits of docosahexaenoic acid, folic acid, vitamin D and iodine on foetal and infant brain development and function following maternal supplementation during pregnancy and lactation. The first case report in the medical literature also appeared in 1967 and involved a female infant with unilateral fibular aplastic syndrome (11,12). The authors acknowledged that neuroblastoma was the second most common malignant solid tumor in childhood and that a causal relationship between the tumor and metronidazole in this case could not be established (10). There was one major defect in each group: small asymptomatic ventricular septal defect (exposed) and bilateral lacrimal duct stenosis that required surgery (control). The effects observed on motor activity, startles, and heart rate variability were not significant after adjustment (13). Pregnancies exposed to estrogens or progesterones were identified prospectively over a 3-year period (1966­1968). It was concluded that the drug therapy was not teratogenic, did not cause ketosis, and that neonatal hypoglycemia was preventable if the therapy was changed to insulin before delivery (24). Although the limited data prevented conclusions on the relative safety of the drugs, the author did state that each case needed to be considered separately (9). Embryo lethality and reduced fetal body weight were observed at the mid and high doses. Serum and milk samples from both breasts were collected at intervals 12 hours after a dose. Several sources state that ingestion of large doses of peppermint/peppermint oil is unsafe in pregnancy because of possible emmenagogue and abortifacient effects. Because influenza infection in pregnancy is a high-risk condition, the maternal benefit far outweighs the unknown risk, if any, to the embryo or fetus. Similarly, no teratogenicity was observed after in vitro exposure of monkey embryos to mifepristone (82,83). The drug is teratogenic in some species of animals after injection and ophthalmic use (1­3). Infants should be monitored for adverse events commonly observed in adults, such as fatigue, syncope, somnolence, dizziness, dyspepsia, and nausea and vomiting. The molecular weight (about 251,000) suggests that passive transfer will not occur, but the long circulation half-life will place the protein at the maternal­fetal interface for a prolonged period. During clinical trials with insulin lispro, pregnancy was an exclusion, but 19 women gave birth to live infants. Among the infants, 8 were delivered prematurely, 12 were growth restricted, and 11 had withdrawal symptoms after birth. She continued the same dose of sertraline for 3 weeks after delivery of a healthy, full-term male infant. More recent reviews on the use of indomethacin as a tocolytic agent appeared in 1992 (37) and 1993 (38). Major skeletal anomalies (ribs and vertebrae) were increased only on day 9, but minor skeletal defects were increased on days 8 and 9.