Information for Patients: How to Interpret the Recent FDA Panel on SSRIs and Pregnancy

Weighing the Evidence Unfortunately, the discussion was one-sided, focusing largely on the risks associated with use of SSRIs during pregnancy and giving more weight to research reporting negative outcomes while ignoring the studies suggesting little or no risk. Most importantly, the panel did not adequately discuss the risks associated with untreated depression in the mother. While every decision must consider the potential risks related to using a particular medication during pregnancy, we cannot ignore the negative effects of untreated psychiatric illness in the mother in this decision-making process. The use of psychiatric medications during pregnancy has long been a polarizing issue. Data gathered over the past 25 years supports the safety of many different types of psychiatric medications during pregnancy, yet we continue to encounter opponents to the use of these during pregnancy. The one-sided panel presented by the FDA has created unnecessary confusion for patients and healthcare providers and, most importantly, put patients—who must ultimately make these decisions—at risk. When considering the use of medications during pregnancy, women are often faced with complex and deeply personal decisions. This process is guided by a careful risk-benefit analysis, where women, together with their healthcare providers, weigh the potential benefits of treatment against possible risks associated with a particular medication. This decision-making process is informed by the best available scientific evidence, illness and treatment history, and the values and preferences of each woman. Recognizing that untreated psychiatric illness in the mother also carries significant risks for both maternal and infant well-being, we advocate for open dialogue, shared decision-making, and individualized care plans that support the health of both mother and child. Where to Go For Information on Medication Safety While there is a lot of information on the internet, not all of the information is reliable or evidence-based. We recommend that you first discuss your medication with your prescriber. If your prescriber is not comfortable with discussing the use of medications during pregnancy, you may choose to seek consultation with a perinatal mental health specialist. Psychiatrists, nurse practitioners, and physician assistants have the authority to prescribe medication; their prescribing rights vary by state. Some of these providers may have a Perinatal Mental Health Certificate (PMH-C); however, there are many excellent providers who have experience in the treatment of perinatal mental health issues who do not have this certification Postpartum Support International maintains an online directory of qualified perinatal mental health professionals in the US, Canada, and Australia. Psychology Today also maintains a list of mental health providers available for in-person or telehealth visits. You can supplement this discussion with information from the following resources: DailyMed is the official source for up-to-date Food and Drug Administration (FDA) medication labeling; this is the information included in the package insert. DailyMed provides detailed information on prescription and over-the-counter drugs, including indications, dosing, side effects, and use during pregnancy and lactation. Our website womensmentalheatlh.org provides up-to-date information on the use of medications and pregnancy. MotherToBaby offers free, evidence-based fact sheets and confidential counseling on medication exposures during pregnancy and breastfeeding. The American College of Obstetricians and Gynecologists (ACOG) issues clinical guidelines for medication use, screening, and management of mental health disorders in pregnancy and postpartum. These documents summarize current best practices for clinicians and patients: Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum. Postpartum Support International (PSI) provides an online provider directory, patient resources, helplines, and educational materials for those seeking help and guidance. Perinatal Psychiatry Access Programs are state-based and national programs that connect clinicians to expert psychiatric consultation and resources to support perinatal mental health. You can find a list of programs HERE. Other Professional Organizations Share Their Opinions Since the airing of the panel many medical organizations and professional groups supporting women with perinatal mood and anxiety disorders have raised similar concerns about the recent FDA panel and have echoed our concerns that this information may actually harm women and their families. American College of Obstetricians and Gynecologists Society for Maternal Fetal Medicine American Psychiatric Association Postpartum Support International National Curriculum of Reproductive Psychiatry Policy Center for Maternal Mental Health Maternal Mental Health Leadership Alliance Adrienne Griffen, Executive Director of the Maternal Mental Health Leadership Alliance (MMHLA) notes, “In the last two decades, meaningful progress has been made in reducing stigma and raising awareness around maternal mental health and appropriate treatment options. But that progress is fragile. Public statements that downplay these conditions—and the available evidence-based treatments—can discourage mothers from seeking the help they need and deserve.”