Biomedical subjects

Myla E Moretti

Publications and source records attributed to Myla E Moretti.

9 recordsLinked to original sources

PubMed2006

Breast-feeding during maternal use of azathioprine.

OBJECTIVE: To report the clinical outcome of infants whose mothers were taking azathioprine while nursing and to quantify the transfer of 6-mercaptopurine (6-MP), its active metabolite, into breast milk. CASE SUMMARY: We report on a series of 4 patients treated with azathioprine while lactating. Breast milk samples were analyzed for 6-MP in 2 of the mothers. Several milk samples per patient were analyzed; levels of 6-MP were undetectable by high performance liquid chromatography (limit of detection 5 ng/mL). Therefore, the absolute relative infant dose would have been less than 0.09% of the maternal weight-adjusted dose. No adverse effects were encountered in any of the 4 infants. DISCUSSION: A large number of women of reproductive age are treated with azathioprine for a range of chronic conditions that require immunosuppression, such as systemic lupus erythematosus or solid organ transplants. Similar to other antimetabolites, the drug has generally been contraindicated for use during breast-feeding because of the theoretical concern for toxicity in the nursing infant. The available literature in this area is sparse and dated. The data presented here confirm published reports of minimal 6-MP excretion into milk, suggesting that significant systemic adverse effects in the infant are unlikely. CONCLUSIONS: Maternal azathioprine use during lactation does not appear to pose a significant immediate clinical risk to the suckling infant. Continued monitoring and long-term assessment of these infants are warranted.

Adult↗

PubMed2006

Nonsteroidal antiinflammatory drugs during third trimester and the risk of premature closure of the ductus arteriosus: a meta-analysis.

BACKGROUND: Nonsteroidal antiinflammatory drugs (NSAIDs) are increasingly being used during pregnancy to treat a variety of conditions. An evaluation of the risk of premature closure of the ductus arteriosus is useful in determining the safety of NSAIDs at different stages of pregnancy. OBJECTIVE: To determine whether NSAID use during the third trimester of pregnancy is associated with an increased risk of premature constriction of the ductus arteriosus. METHODS: A systematic review was conducted of MEDLINE (1966-2004), Embase (1980-2004), and the Cochrane Database of Systematic Reviews (1991-2004). Summary estimates of the odds ratios, comparing ductal outcomes in exposed and unexposed fetuses, and their 95% confidence intervals were calculated assuming a random effects model. RESULTS: Based on 217 patients exposed to indomethacin and 221 to placebo, the risk of ductal closure was 15-fold higher in the group of women exposed to NSAIDs compared with those receiving either placebo or other NSAIDs (8 studies; OR = 15.04, 95% CI 3.29 to 68.68). There was no significant increased risk of ductal closure in the infants of women treated with indomethacin compared with those receiving other drugs (4 studies; OR = 2.12, 95% CI 0.48 to 9.25). Similar results were found when calculating rate differences. CONCLUSIONS: Short-term use of NSAIDs in late pregnancy is associated with a significant increase in the risk of premature ductal closure.

Abnormalities, Drug-Induced↗

PubMed2006

Major malformations with valproic acid.

QUESTION: Increasing numbers of pregnant patients are treated with valproic acid, not just for epilepsy, but also for psychiatric conditions. Are there teratogenic risks other than the risk of spina bifida? ANSWER: It has now become evident that valproic acid might cause more than just neural tube defects (NTDs). In a systematic review of all cohort studies intended to answer this question, higher rates of major malformations (and not just NTDs) were found in most studies. The calculated relative risk was 2.59 when compared with other antiepileptic drugs and was 3.77 when compared with risk in the general population. There is compelling evidence that the risk is dose dependent. The risks appear to begin increasing at doses of 600 mg/d and to become more prominent at doses above 1000 mg/d.

Abnormalities, Drug-Induced↗

PubMed2005

Maternal hyperthermia and the risk for neural tube defects in offspring: systematic review and meta-analysis.

BACKGROUND: In animals, excessive core body temperatures have been documented to cause malformations; neural tube defects (NTDs) are among the most frequently reported. In humans, data are inconclusive and often conflicting. The objective of our report is to determine the risk for neural tube defects associated with maternal hyperthermia in early pregnancy. METHODS: We conducted a systematic review and meta-analysis to evaluate available evidence on this topic in humans. MEDLINE, EMBASE, references from published reports, and biologic abstracts from meetings were searched for relevant studies. Reviewers evaluated all the retrieved articles and extracted the relevant data. Individual and summary odds ratios and relative risks were calculated using the Mantel-Haenszel method. RESULTS: Fifteen studies, reporting on 1,719 cases and 37,898 noncases, were included in the meta-analysis. The overall odds ratio for neural tube defects associated with maternal hyperthermia was 1.92 (95% confidence interval = 1.61-2.29). When analyzed separately, the 9 case-control studies had an odds ratio of 1.93 (1.53-2.42). The summary relative risk for the 6 cohort studies was 1.95 (1.30-2.92). CONCLUSIONS: Maternal hyperthermia in early pregnancy is associated with increased risk for neural tube defects and may be a human teratogen.

Adult↗

PubMed2004

Pregnancy outcome following rubella vaccination: a prospective controlled study.

The rubella virus is a potent human teratogen. Because the rubella vaccine is prepared with live virus, a high level of anxiety surrounds exposure in pregnancy. There is relatively scarce data on fetal risk following vaccination in pregnancy, and all of the available data were collected retrospectively. Our objective was to examine whether periconceptional exposure to rubella vaccine can cause the congenital rubella syndrome, and to compare the rate of major malformations and developmental milestones among offspring of women who received rubella vaccine 3 months pre- or post-conception to an unexposed comparison group. We collected prospectively and followed up 94 women who received rubella vaccination 3 months pre- or post-conception and a comparison group that consisted of 94 women who were counseled during pregnancy in a similar manner but were not exposed to known teratogens. The controls were matched for age, smoking, alcohol, and drug use. Not any of the women exposed to the vaccine gave birth to a child with congenital rubella syndrome. Rates of major malformations were similar in both groups as were birth weights and developmental milestones. In contrast, the rate of therapeutic abortions was higher in the exposed group (7.4% vs. 0%) (P < 0.05), due to fears of teratogenicity. We conclude that rubella vaccination in pregnancy does not appear to affect pregnancy outcome in general or cause congenital rubella syndrome in particular.

Abortion, Therapeutic↗

PubMed2003

Cyclosporine excretion into breast milk.

Although many female patients of childbearing age who are receiving cyclosporine have successful pregnancies, these women may be advised not to breast-feed. During recent years, cases of uneventful pregnancies and subsequent successful breast-feeding have been reported in the literature. The infant's blood cyclosporine concentration was usually very low. Based on these findings and the lack of detectable adverse effects, some investigators have suggested that women on cyclosporine may breast-feed, challenging the conventional view that cyclosporine is contraindicated during breast-feeding. Here, we report our experience with cyclosporine use during breast-feeding in five mother-infant pairs. We show a wide range of infant exposures to the drug in milk, noting that one of the infants had therapeutic blood concentrations of cyclosporine despite relatively low concentrations of the drug in milk.

Cyclosporine↗

PubMed2003

Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study.

BACKGROUND: Women in their childbearing years often require drug therapy for allergic conditions. Loratadine, a newer nonsedating antihistamine, is often used because of its preferred side effect profile. To date no published data exist on the safety of loratadine use in pregnancy. OBJECTIVE: We sought to determine whether the use of loratadine in the first trimester of pregnancy was associated with an increased risk for major malformations. Secondary outcomes included rates of miscarriage, birth weights, and gestational age at delivery. METHODS: All women were prospectively enrolled from 4 participating centers. Detailed maternal medical history and drug exposures were collected at intake, whereas pregnancy complications and outcomes were collected at follow-up. A group of unexposed control subjects were recruited and followed up in a similar manner. RESULTS: This report includes follow-up on 161 loratadine exposed pregnancies and an equal number of unexposed control subjects. Maternal characteristics (age, pregnancy history, alcohol consumption, and smoking habits) were not different between the 2 groups. There were 5 malformations observed in the exposed group and 6 in the control group, which was not significantly different (P =.9) Similarly, the live birth rate, gestational age at delivery, and birth weights were not different between the 2 groups. CONCLUSION: These results suggest that loratadine use in pregnancy is not associated with a large risk for major malformations. Further studies are warranted to confirm these findings and to increase study power.

Abnormalities, Drug-Induced↗

PubMed2003

Monitoring lithium in breast milk: an individualized approach for breast-feeding mothers.

Lithium is a drug of choice for the management of bipolar disorder, a disease frequently affecting women in their childbearing years. Unfortunately, this drug has typically been contraindicated in nursing women. Data in humans are limited with respect to the use of this drug in lactating women, and early reports suggest high excretion into milk. The purpose of this report was to verify the excretion of lithium into human milk and to assess infant safety after breast-feeding. The authors found wide interpatient variability in lithium dose offered to the infant through breast milk (from 0% to 30% of maternal weight-adjusted dose), indicating that therapeutic drug monitoring of lithium in milk and/or in infant's blood, coupled with close monitoring of adverse effects, is a rational approach. Since therapeutic drug monitoring of lithium is routine, physicians caring for these women and infants should be encouraged to individualize their recommendations.

Bipolar Disorder↗

PubMed2002

Use of proton pump inhibitors during pregnancy and rates of major malformations: a meta-analysis.

Proton pump inhibitors are used to treat gastroesophageal reflux, a symptom common in pregnancy. The aim of this study was to systematically analyze the available data on the risk for malformations following use of these agents in the first trimester of pregnancy. Medline, EMBASE, published abstracts, and reference lists were searched for articles reporting on proton pump inhibitor use in pregnancy. Summary relative risks and 95% confidence intervals (95% CI) were calculated using the Mantel-Haenszel method. Five cohort studies met the inclusion criteria for this meta-analysis. With almost 600 exposed pregnancies, the overall relative risk was 1.18 with a 95%CI of 0.72-1.94. In conclusion, proton pump inhibitors do not present a major teratogenic risk when used in recommend doses. These data are reassuring for the countless patients who have used these agents in the early part of their pregnancies.

Abnormalities, Drug-Induced↗