Posted on Leave a comment

The first postpartum depression pill has been approved by the FDA in the US.

The US Food and Drug Administration has granted approval for the medication zuranolone to treat postpartum depression, marking a significant milestone as it becomes the first FDA-approved oral pill specifically designed for postpartum depression in the United States. Postpartum depression, a serious mental illness affecting approximately 1 in 7 new mothers after childbirth, can lead to profound emotional distress, including feelings of sadness, guilt, and worthlessness, and in severe cases, even thoughts of self-harm or harm to the child.

The newly approved treatment, to be marketed under the brand name Zurzuvae, is administered as a once-daily pill to be taken over a 14-day period. The FDA’s announcement on Friday emphasized the importance of this medical advancement, given the potential life-threatening nature of postpartum depression and its potential impact on the maternal-infant bond, as well as the child’s overall physical and emotional development.

Dr. Tiffany R. Farchione, the director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, highlighted the significance of having an oral medication option for women facing extreme and potentially life-threatening emotions during this critical postpartum period. The approval of zuranolone offers a valuable and beneficial treatment option for those struggling with postpartum depression, providing hope for improved maternal mental health and well-being.

The FDA has added a boxed warning to the drug’s labeling, alerting users about its potential to impair driving and other hazardous activities. Patients may be unable to accurately assess their level of impairment, necessitating precautions to minimize harm. As a safety measure, the agency advises patients not to drive or operate heavy machinery for at least 12 hours after taking the drug.

The most common side effects cited by the FDA include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection. Additionally, the drug’s use has been associated with an increased risk of suicidal thoughts and behavior, as well as potential harm to the fetus. To mitigate these risks, the agency recommends that women use effective contraception while taking the medication and for one week after its use.

Notably, severe postpartum depression may lead to suicidal ideation, with maternal suicides accounting for approximately 20% of all postpartum deaths. The FDA’s comprehensive warning aims to raise awareness of potential risks and promote safer medication practices for individuals experiencing postpartum depression.

Each year in the United States, it is estimated that over 400,000 babies are born to mothers experiencing depression. Without appropriate treatment, postpartum depression can persist for months or even years, as highlighted by the National Institute of Mental Health.