Calls to a Major Teratogen Information Service Regarding Exposures During Breastfeeding.

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.

Phone calls to an Australian pregnancy and lactation counselling service regarding use of galactagogues during lactation - the MotherSafe experience.

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.

Critical caveats in using product information/pregnancy categories for pregnant or breastfeeding patients

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.

Counselling regarding paternal exposures: Can we do better?

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.

Abnormal pregnancy outcome associated with high-dose maternal tranylcypromine therapy: Case report and literature review.

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.

Review of calls to an Australian teratogen information service regarding psychotropic medications over a 12-year period.

BACKGROUND: Telephone counselling services are increasingly utilised by consumers to obtain contemporary and confidential information about perinatal drug and toxin exposure. The use of such services in regard to psychotropic agents is unknown. AIM: To determine the frequency and types of calls to a New South Wales (NSW)-based telephone counselling service regarding perinatal psychotropic agent exposure between 2000 and 2011. METHODS: Retrospective analyses of MotherSafe call data between two epochs: I (2000-2005, n = 46,277) and II (2006-2011, n = 118,587), total 164,864 calls. RESULTS: 25,698 (15.6%) calls were made about psychotropic agents: 16,218 (9.8%) about antidepressants, 3,145 calls (1.9%) about mood stabilisers/antiepileptic agents, 2,878 (1.7%) about benzodiazepines and 3,457 (2.1%) about antipsychotic drugs. Calls regarding psychotropic agents doubled in epoch II (18,231 vs 7,467, epoch I) but decreased as a proportion of total calls (I: 16.1% vs II: 15.4%, P < 0.001). Selective serotonin inhibitors (SSRIs) were the most common drugs of concern (>44% of total psychotropic calls). The proportion of calls regarding particular agents changed significantly between epochs, for example paroxetine (epoch I: 14.8% vs epoch II: 6.7% of all antidepressant calls, P < 0.001) and quetiapine (epoch 1: 10.6% vs epoch II: 34.7% of all antipsychotic calls (P < 0.001). Calls from rural areas of NSW increased from 22.6 to 24.7% (P < 0.001). CONCLUSION: Consumer demand for information about the use of psychotropic agents for women of child-bearing age has increased considerably over the last decade, particularly in rural areas of Australia. This indicates a need to review current existing services, particularly for rural consumers.