Comment from American Psychiatric Association

We oppose the citizens petition requesting the U.S. Food and Drug Administration (FDA) to require a boxed warning for the use of Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy. A boxed warning is the FDA’s most serious form of safety communication and are only added when substantial clinical evidence demonstrates a drug can cause severe harm, hospitalization of death. The available scientific evidence does not support this conclusion. The addition of a boxed warning in the absence of data demonstrating substantial risk of maternal or fetal harm would inappropriately deter both physicians and patients from considering clinically indicated, safe, effective, and potentially life-saving treatment. Recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects. In fact, the overall evidence suggests that individuals can and should take SSRIs prior to or during pregnancy, when they are clinically indicated for treatment. The analysis goes on to say that some concerns with specific SSRIs have emerged. While some studies have raised concerns related to specific SSRIs, these findings do not warrant a class-wide boxed warning and should be individually addressed between the patient and physician to partner in decision making ensuring the best outcomes for the patient and the fetus, as is the case for any drug. Physicians should also work closely with patients to assess the risks and benefits of psychopharmacotherapy and monitor for potential side effects, ensuring each patient receives individualized care. The American College of Obstetricians and Gynecologists (ACOG) Guidelines on Psychiatric Medication Use During Pregnancy and Lactation are widely used by physicians to treat perinatal and pregnant individuals, and it states, “Treatment with SSRIs or selective norepinephrine reuptake inhibitors during pregnancy should be individualized.” ACOGs guidelines also strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone. Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly -- as directed --under the care of an appropriately licensed healthcare professional. Unmanaged or inadequately treated perinatal mental health disorders are associated with adverse outcomes for pregnant individuals and fetus/child, including increased morbidity and mortality both short-term and long-term. Suicide is a major cause of mortality for women in the perinatal period, accounting for 5–20% of maternal deaths. Appropriate treatment of these conditions, including SSRIs when indicated, can reduce the risk of these adverse outcomes. A boxed warning will likely exacerbate stigma surrounding psychiatric conditions, leading to decreased communication of patients' symptoms to their healthcare providers and increased morbidity and mortality for mother and child. Thank you for the opportunity to provide these comments.