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Background Many healthcare professionals (HCPs) base their advice to pregnant or breastfeeding women on Monthly Index of Medical Specialties, Medical Director or the Consumer Medicines Information, which draw from manufacturers’ product information. This information does not reflect evidence-based studies, but rather is based on animal studies conducted prior to the product’s approval for use in humans and is rarely updated. Objective The aim of this paper is to inform HCPs of the evidence-based resources available to assist decision making when treating pregnant or breastfeeding women. Discussion Women often have conditions that require treatment during their pregnancies. Experience at MotherSafe indicates that women who are pregnant or breastfeeding are frequently treated with excessive caution or even refused needed treatment by doctors and pharmacists. Product information and evidence-based sources often vary greatly in their recommendations for pregnant and lactating women. By not assessing the risks and benefits for their patients, an adverse outcome for mothers and babies may well be the result – the very outcome the cautious approach of HCPs seeks to avoid.

Galactagogues represent substances used to enhance breast milk production. Between 2001 and 2014 we identified 2034 phone calls regarding the use of galactagogues made to MotherSafe. The majority involved discussion of domperidone (n = 1884; 92.6%), with the remainder relating to metoclopramide (n = 153; 7.5%) or other herbal galactagogues (eg fenugreek, milk thistle; n = 262; 12.9%). A 50% decrease in total calls occurred from 2011 to 2014, while the percentage of calls regarding herbal galactagogues increased from 0% in 2001 to 23% in 2014. These findings support the need for more robust research surrounding the use of galactagogues in clinical practice.

Background Tranylcypromine is a non-selective inhibitor of monamine oxidase which also inhibits the reuptake of norepinephrine. Spontaneous hypertensive reactions to the drug have been reported. In sheep tranylcypromine has been shown to cause a dose-dependent reduction in uterine blood flow. A similar effect in a pregnant woman might induce constriction of the uterine arteries and temporary fetal hypoxia. Cases MotherSafe is a state-based Teratogen Information service and currently provides counselling to around 22,000 consumers and healthcare professionals annually regarding exposures during pregnancy and breastfeeding We report on the outcome of 2 pregnancies in a patient treated with high dose tranylcypromine as well as pimozide, diazepam and alprazolam. The first pregnancy resulted in fetal death and autopsy revealed facial dysmorphism with ocular hypertelorism, cardiac defect and placental infarcts. The second pregnancy continued to term but the baby had similar dysmorphic features as well as an atrio-ventricular septal defect and craniosynostosis. Conclusions Due to their unpredictable interactions with many drugs and foods, MAO inhibitors such as tranylcypromine are not commonly used to treat depression and reports of use in pregnancy are rare. We report the outcome of 2 pregnancies with exposure to high doses of tranylcypromine resulting in children with a similar pattern of malformations. The aetiology is unknown but may relate to the vasoactive properties of the drug in above-therapeutic doses.

Background MotherSafe is a free telephone-based counselling service for the general public and healthcare providers concerned about exposures during pregnancy and breastfeeding. Calls relating to paternal exposures are less common, but can cause distress to the person concerned. This review seeks to identify the key concerns and what information is available to address these concerns. Aims To review calls made to MotherSafe about paternal exposures to teratogens during the 16 year period, 2000-2015, and to document any patterns or changes in calls over the period. Materials and methods A retrospective descriptive assessment of a prospectively collected database (2000-2015) was undertaken. Telephone counselling records identified the drugs of concern regarding paternal exposures. The information about paternal exposures provided in consumer and production information was also reviewed. Results Of a total of 253 103 calls received at MotherSafe between 2000 and 2015, 1072 calls (0.4%) were regarding paternal exposures. The majority of these calls related to immunomodifiers (19%), hair loss products (11%) and antidepressant medications. Conclusions Paternal exposures represent a small proportion of all the counselling calls made to MotherSafe. The study highlighted the deficient and often misleading information about paternal exposures found in most consumer and product information sheets or via the internet. The study indicates the important role of Teratogen Information Services like Mothersafe in providing evidence-based information to both consumers and healthcare providers.

Background: MotherSafe is a free telephone-based counseling service for Australian consumers and health care providers concerned about drug exposures during pregnancy and breastfeeding. Calls relating to breastfeeding are relatively common and a source of significant distress to the breastfeeding mother, particularly if there is a lack of clarity regarding possible adverse effects of drug exposure on the infant. This study seeks to identify the medication exposures of concern for breastfeeding mothers and the information available to address these concerns. Aims: To review calls to MotherSafe about breastfeeding drug exposures during the 19-year period from 2000 to 2018 and to highlight drugs of concern and counseling issues. Materials and Methods: A retrospective descriptive assessment of a prospectively collected Access database was undertaken. Phone counseling records identified the medication (and other) exposures of concern regarding breastfeeding. The information about medication exposures via breastfeeding provided in consumer and product information (PI) was also reviewed. Results: Of a total of 315,158 calls received at MotherSafe between 2000 and 2018, 116,876 (37.1%) were regarding drug exposure via breastfeeding; 30% of these calls related to nonsteroidal anti-inflammatory drugs, antihistamines, antidepressants, simple analgesics, and antibiotics, and 5% were regarding an exposure specifically contraindicated when breastfeeding. Conclusions: Queries about medication exposures via breastfeeding represent a significant proportion of all the counseling calls to MotherSafe. This study demonstrates the inconsistent and often misleading information about breastfeeding exposures found in consumer and PI sheets and online and highlights the important role of Teratogen Information Services like MotherSafe in providing evidence-based information to both consumers and health care providers.

MotherSafe is a state-wide service operating in New South Wales, Australia. MotherSafe offers counselling services for pregnant or breastfeeding mothers regarding the potential effects of exposure to medications, radiation, possible environmental hazards, street drugs or household products, as well as the effects of occupation upon pregnancy and breastfeeding outcomes. Consumers call MotherSafe to check advice having been given by healthcare professionals, only to find that the advice has been unnecessarily alarming to the woman, and in many cases it is incorrect purely because the advice that has been provided is based upon a construct that has considered the pregnancy categorisation of the drug as an absolute fact, or upon an assumption that information relevant to pregnancy is also applicable to breastfeeding as well. Outlined here are a series of issues that should be considered in the provision of advice on these issues as they relate to pregnancy and breastfeeding, as well as a summary of the resources available to inform evidence-based advice.