Skip to content

FDA advisory panel disseminates incorrect information regarding SSRI usage during pregnancy, causing concern among medical professionals

FDA-led panel raises concerns over antidepressant safety during pregnancy, sparking dissent from physicians who view selective serotonin reuptake inhibitors (SSRIs) as essential for managing perinatal depression.

Pharmaceutical agency's panel disseminates false information regarding SSRI intake during...
Pharmaceutical agency's panel disseminates false information regarding SSRI intake during pregnancy, causing concern among healthcare professionals

FDA advisory panel disseminates incorrect information regarding SSRI usage during pregnancy, causing concern among medical professionals

In the realm of maternal health, a recent FDA advisory panel proposed stronger warnings on the use of Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy, citing potential increased risks of autism, miscarriage, and birth defects. However, this proposal has sparked significant controversy among experts and medical societies.

Dr. Steven Fleischman, President of the American College of Obstetricians and Gynecologists (ACOG), is among the critics, arguing that the panel failed to properly consider SSRIs as a critical tool to prevent anxiety and depression's devastating effects during pregnancy. The Society for Maternal-Fetal Medicine (SMFM) has also criticised the panel for making unsubstantiated and inaccurate claims concerning maternal depression and the use of SSRI antidepressants during pregnancy.

Dr. Jennifer Payne, a reproductive psychiatrist, echoes these sentiments, stating that some of the studies cited by the panelists as evidence of harm didn't involve pregnant and postpartum women. Furthermore, she points out that many of these studies are poorly controlled, and several have been disproven.

Despite these concerns, the current consensus among leading medical societies like ACOG and SMFM is that antidepressants, specifically SSRIs, are generally safe and important for managing depression during pregnancy. Mental health remains the leading cause of maternal deaths in the United States, including deaths from suicide.

Dr. Christopher Zahn, chief of Clinical practice with ACOG, emphasises the importance of studies comparing pregnant women on SSRIs with pregnant women with mental health abnormalities who haven't taken SSRIs for accurate comparison. This approach acknowledges the manageable risks associated with neonatal adaptation syndrome and developmental complications, which are generally outweighed by the hazards of untreated depression.

Approximately 6-8% of pregnant women are prescribed SSRIs, and for those with moderate to severe symptoms or who can't access therapy quickly, SSRIs are a helpful option, according to Dr. Nancy Byatt. For mild depression or anxiety, the first line of treatment is psychotherapy, or talk therapy, and there are evidence-based psychotherapies that can be used in pregnancy and postpartum.

Dr. Byatt, a perinatal psychiatrist at the UMass Chan School of Medicine, asserts that the use of SSRIs in pregnancy is extremely well studied, with data on hundreds and thousands of individuals exposed to SSRIs in pregnancy. She also recommends psychosocial treatments, like peer support, and adding practices like exercise, yoga, and meditation to treatment plans.

It's worth noting that nearly one in five pregnant women and new moms in the U.S. suffer from anxiety and depression. Dr. Kay Roussos-Ross, OBGYN and perinatal psychiatrist at the University of Florida, highlights that untreated mental health symptoms in pregnant and postpartum women lead to less prenatal care attendance, increased substance use during pregnancy, higher risks of pre-eclampsia, cesarean delivery, and suicide.

In summary, despite the FDA panel's concerns and proposals for more cautionary labeling, the prevailing expert medical opinion supports the continued use of antidepressants during pregnancy when indicated. This stance is based on the well-established risks of untreated maternal mental illness and the lack of conclusive evidence that SSRIs cause significant harm to the fetus.

  1. The proposal for stronger warnings on the use of SSRIs during pregnancy, proposed by a recent FDA advisory panel, has ignited intense debate among experts and medical societies.
  2. Dr. Steven Fleischman, President of the American College of Obstetricians and Gynecologists (ACOG), voices his disapproval towards the panel's inadequate consideration of SSRIs as a beneficial tool for managing anxiety and depression during pregnancy.
  3. The Society for Maternal-Fetal Medicine (SMFM) also criticizes the panel for making unwarranted claims about maternal depression and the use of SSRI antidepressants during pregnancy.
  4. In contrast to the panel's views, many leading medical societies like ACOG and SMFM maintain that antidepressants, particularly SSRIs, are generally safe and essential for addressing depression during pregnancy.
  5. Mental health is the leading cause of maternal deaths in the United States, encompassing deaths from suicide.
  6. Dr. Christopher Zahn, ACOG's chief of Clinical practice, underlines the need for studies comparing pregnant women on SSRIs with pregnant women with mental health abnormalities who haven't taken SSRIs, to ensure accurate comparisons.
  7. Approximately 6-8% of pregnant women are prescribed SSRIs, and for those with severe symptoms or limited access to therapy, SSRIs provide a beneficial alternative.
  8. For mild depression or anxiety, psychotherapy is typically the first line of treatment.
  9. Dr. Nancy Byatt, a perinatal psychiatrist at the UMass Chan School of Medicine, affirms that the use of SSRIs in pregnancy is well-studied with extensive data on hundreds and thousands of individuals exposed to SSRIs during pregnancy.
  10. Dr. Byatt advocates for psychosocial treatments, such as peer support, and integrating practices like exercise, yoga, and meditation into treatment plans.
  11. Almost one in five pregnant women and new moms in the U.S. grapple with anxiety and depression.
  12. Dr. Kay Roussos-Ross, an OBGYN and perinatal psychiatrist at the University of Florida, underscores the adverse consequences of untreated mental health symptoms in pregnant and postpartum women, including decreased prenatal care attendance, increased substance use, higher risks of pre-eclampsia, cesarean delivery, and suicide.
  13. In essence, while the FDA panel's recommendations lean towards more cautious labeling, the prevailing expert medical opinion advocates for the continuation of using antidepressants during pregnancy when appropriate.
  14. This stance is grounded in the well-documented risks associated with untreated maternal mental illness and the absence of conclusive evidence linking SSRIs to significant harm to the fetus.

Read also:

    Latest