Maya Berlin

Pregnancy outcome following maternal exposure to statins: a multicentre prospective study

This contribution addresses the risk associated with exposure to statins during pregnancy.

Pregnancy Outcome Following Exposure to Topical Retinoids: A Multicenter Prospective Study

Concerns have been raised about the use of topical retinoids since the publication of isolated cases of characteristic retinoid embryopathy, originally described after oral use. A collaborative study of the European Network of Teratology Information Services was carried out to evaluate the rate of congenital malformations following first‐trimester topical retinoid exposure. A population of 235 exposed pregnant women was compared with 444 controls. No significant differences were observed between groups with regard to the rates of spontaneous abortion (odds ratio [95% confidence interval], 1.5 [0.8–2.7]), minor birth defects (1.3 [0.4–3.7]), and major birth defects (1.8 [0.6–5.4]). No child showed features of retinoid embryopathy. The rate of elective termination in the exposed group was increased 3‐fold (3.4 [1.5–7.8]). In conclusion, these results do not suggest an increased risk of retinoid embryopathy. However, according to current knowledge, topical retinoids cannot be advised for use during pregnancy because their risk/benefit ratio remains questionable.

The outcomes of pregnancy in women exposed to the new macrolides in the first trimester: a prospective, multicentre, observational study.

AbstractBackground: Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. Objective: The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic preparations. Methods; In this prospective, multinational, multicentre, controlled, observational study, information was obtained either from pregnant women or their healthcare professionals who contacted their local teratogen information services in Italy, Israel, the Czech Republic, the Netherlands and Germany seeking information after exposure to macrolides. The comparison group included women or their healthcare professional who contacted these centreswithquestionsregardingknownnon-teratogenicpreparations. Information on obstetric and other background parameters was collected at enrollment; after delivery, subjects or their healthcare professionals were contacted to ascertain pregnancy outcome parameters and other exposures through the remainder of the pregnancy. Results: A total of 608 women exposed to macrolides during pregnancy were enrolled; 511 of the exposures occurred during the first trimester. The comparison group comprised 773 women exposed to non-teratogenic preparations during the first trimester of pregnancy. No significant difference in the rate of major congenital malformations was found between the study group and the comparison group (3.4% vs 2.4%; p = 0.36; odds ratio (OR) 1.42; 95% CI 0.70, 2.88) or in the rate of cardiovascular malformations (1.6% vs 0.9%; p = 0.265; OR 1.91; 95% CI 0.63, 5.62).No significant differences were found between subgroups of macrolides in the rates of major congenital malformations or cardiac malformations, although for azithromycin this was of borderline significance. Conclusions: This study, in agreement with earlier smaller studies, suggests that the new macrolides do not pose a significantly increased risk of major congenital malformations or cardiac malformations.

Pregnancy outcome following maternal exposure to mirtazapine: a multicenter, prospective study.

Abstract This multicenter, observational prospective cohort study addresses the risk associated with exposure to mirtazapine during pregnancy. Pregnancy outcomes after exposure to mirtazapine were compared with 2 matched control groups: (1) exposure to any selective serotonin reuptake inhibitor (SSRI, control subjects with a psychiatric condition) and (2) no exposure to medication known to be teratogenic or any antidepressant (general control subjects). Data were collected by members of the European Network of Teratology Information Services between 1995 and 2011. Observations from 357 exposed pregnancies were compared with 357 pregnancies from each control group. The rate of major birth defects between the mirtazapine and the SSRI group did not differ significantly (4.5% vs 4.2%; odds ratio [OR], 1.1; 95% confidence interval [95% CI], 0.5–2.3; P = 0.9). A trend toward a higher rate of birth defects in the mirtazapine group compared with general control subjects (4.5% vs 1.9%; OR, 2.4; 95% CI, 0.9–6.3; P = 0.08) reached statistical significance after exclusion of chromosomal or genetic anomalies (4.1% vs 1.3%; OR, 3.3; 95% CI, 1.04–10.3; P = 0.03), but this difference became again nonsignificant if cases of exposure not comprising the first trimester were excluded from the analysis (3.4% vs 1.9%; OR, 1.8; 95% CI, 0.6–5.0; P = 0.26). The crude miscarriage rate did not differ significantly between the mirtazapine, the SSRI, and the general control groups (12.1% vs 12.0% vs 9.3%; P = 0.44). However, a higher rate of elective pregnancy termination was observed in the mirtazapine group compared with SSRI and general control subjects (7.8% vs 3.4% vs 5.6%; P = 0.03). This study did not observe a statistically significant difference in the rate of major birth defects after first-trimester exposure between mirtazapine, SSRI-exposed, and nonexposed pregnancies. A marginally higher rate of birth defects was, however, observed in the mirtazapine and SSRI groups compared with the low rate of birth defects in our general control subjects. Overall pregnancy outcome after mirtazapine exposure was similar to that of the SSRI-exposed control group.

Effectiveness of oral vs rectal acetaminophen: a meta-analysis.

OBJECTIVE To determine, on the basis of published studies, the efficacy of rectal vs oral acetaminophen as treatment of fever and pain. DATA SOURCES MEDLINE, PubMed, and the Cochrane database as well as major pharmacologic textbooks and the references of all included studies were searched for studies comparing oral and rectal administration of acetaminophen. STUDY SELECTION Randomized and quasi-randomized controlled studies comparing rectal and oral administration of acetaminophen were included. Reviews, letters, and studies that compared combined treatments or additional drugs were excluded. Main Exposure Oral vs rectal acetaminophen. MAIN OUTCOME MEASURES Standardized measures of temperature and pain reduction. RESULTS For temperature reduction, 4 studies met the inclusion criteria. The decline in temperature 1 hour after administration of acetaminophen was no different between rectal and oral administration (weighted mean difference [WMD], -0.14 degrees C; 95% confidence interval [CI], -0.36 degrees C to 0.08 degrees C; P for heterogeneity = .49). There was no difference in the decline of temperature 3 hours after administration (WMD, -0.10 degrees C; 95% CI, -0.41 degrees C to 0.21 degrees C; P = .84), the maximum decline in temperature (WMD, -0.10 degrees C; 95% CI, -0.24 degrees C to 0.04 degrees C; P > .99), or the average time to temperature reduction of 1 degrees C (WMD, -0.06 degrees C; 95% CI, -1.34 degrees C to 1.23 degrees C; P < .001). We did not perform a meta-analysis comparing rectal and oral acetaminophen for pain reduction because only 1 study fulfilled the inclusion criteria. CONCLUSIONS Rectal and oral acetaminophen are comparable with respect to temperature reduction. The American Academy of Pediatrics recommendation to refrain from rectal acetaminophen in children should possibly be revised.

Chronic use of psychotropic medications in breastfeeding women: Is it safe?

Background Current knowledge regarding chronic use of psychotropic medications during breastfeeding is limited. The objective of this study was to evaluate the long-term effects of psychotropic monotherapy use during lactation on the breastfed infant. Materials and methods In this prospective study, we followed 280 infants whose mothers contacted the Drug Consultation Center (DCC) at Assaf Harofeh Medical Center between January 2011 and December 2015, seeking information regarding the chronic use of psychotropic medications during lactation. This group was compared with a group of 152 callers, who inquired evidence regarding the use of antibiotics compatible with breastfeeding. Information on adverse effects, physical measures and gross motor developmental milestone achievements of the breastfed infants was obtained during a follow-up telephone interview. At follow up, the median age of the infants in the Psychotropic-drug group was 20 (11–33) months versus 36 (20–48) months in the Antibiotic group (p < 0.001). The outcomes were compared between the groups followed by a propensity score matching to control for difference in baseline characteristics. Results At follow-up, no significant differences between infants in the two groups were observed with regard to height, weight, head circumference and weight-length ratio percentile (p = 0.339, p = 0.223, p = 0.738, p = 0.926, respectively). Children in both groups were, according to their parents, within the normal developmental range for all milestones, according to the Denver Developmental Scale. Use of psychotropic medications during breastfeeding was not significantly associated with adverse reactions. After propensity score matching (n = 120 pairs) to control for differences in baseline characteristics and the length of lactation, only one significant difference was reported, sleepiness in infants in the study group (7/120) and none in the comparison group (p = 0.008). Conclusions Chronic use of psychotropic monotherapy during lactation is associated with normal growth and gross motor developmental as by milestone achievements reported by parents. Sleepiness was reported, it seemed self-limited with no developmental effect.

Use of Psychotropic Medications in Breastfeeding Women

Breastfeeding women who are prescribed with psychotropic medications on a regular basis are often concerned, regarding the possible implications of such treatment on the breastfed infant. A mothers well‐being has a direct influence on the well‐being of the baby. However, the notorious reputation of psychotropic medications may lead to suboptimal prescribing by the physician and poor adherence by the mother.

Safety of Mebendazole Use During Lactation: A Case Series Report.

IntroductionMebendazole is an effective drug widely used in the treatment of parasitic infections. Although theoretically considered as safe during lactation, no studies have evaluated its potential adverse effects in infants of breastfeeding mothers.ObjectivesWe aimed to evaluate the safety of mebendazole in infants of lactating women treated with the drug.MethodsWomen referred for consultation regarding mebendazole use were invited to participate in the study. Overall 45 lactating women treated with various protocols of mebendazole were recruited in this case series study.ResultsRegardless of the treatment protocol used (single or repeated doses) mebendazole was well tolerated and was not associated with any adverse effects in infants of lactating mothers. There was mild GI irritability in two treated women.ConclusionThis study provides first evidence in humans as to the safety of mebendazole in breastfeeding.

Authors' response to: Statins in pregnancy: safety and perspectives of therapeutic applications.

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Correction: Chronic use of psychotropic medications in breastfeeding women: Is it safe?

[This corrects the article DOI: 10.1371/journal.pone.0197196.].