An FDA panel debated whether the use of some antidepressant medications during pregnancy should come with stronger warnings, The New York Times reported July 21.
A spokesperson for HHS would not comment to the Times on whether the agency was planning to require a black box warning for the use of selective serotonin reuptake inhibitors, the most common class of antidepressants, in pregnancy.
The FDA convened a panel of experts to discuss the safety of antidepressants during pregnancy, and around half said women should receive stronger warnings about potential risks SSRIs could cause to a fetus.
FDA Commissioner Marty Makary, MD, said SSRIs have been “implicated in different studies” to be associated with postpartum hemorrhage, pulmonary hypertension and cardiac birth defects, according to the Times.
The American College of Obstetricians and Gynecologists called the panel “alarmingly unbalanced.”
“On a panel of 10 experts, only one spoke to the importance of SSRIs in pregnancy as a critical tool, among others, in preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy,” Steven Fleischman, MD, chair of the college, said in a July 21 news release.
“Robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defect,” Dr. Fleischman said.
The Trump administration has taken a skeptical approach to psychiatric medications. In February, the president directed HHS to investigate potential “threats” posed to children by the use of SSRIs, mood stabilizers, stimulants and other drugs.
HHS Administrator Robert F. Kennedy, Jr. has also criticized medication treatments for behavioral health conditions.
Read the Times’ full report here.
