FDA approves first postpartum depression pill in the US
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The FDA stated on Friday that the medication, to be offered under the trade name Zurzuvae, has been authorized as a once-daily tablet to be taken for 14 days.
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Postpartum depression affects 1 in 7 new mothers after childbirth. (AP)
Zuranolone has been approved by the US Food and Drug Administration to treat postpartum depression, the first FDA-approved oral pill in the US for the condition.
Postpartum depression is a serious mental condition that develops in nearly 1 in 7 new mothers after childbirth.
The FDA stated on Friday that the medication, to be offered under the trade name Zurzuvae, has been authorized as a once-daily tablet to be taken for 14 days.
According to Dr. Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research program, access to the drug will be beneficial for many women "coping with extreme, and sometimes life-threatening, feelings.”
Read more: Medical experts say depression to become largest global health crisis
Suicidal thoughts may occur in women suffering from severe postpartum depression, and maternal suicide accounts for around 20% of all postpartum fatalities. It is estimated that over 400,000 infants are delivered to depressed moms in the United States each year. According to the National Institute of Mental Health, postpartum depression can persist for months or even years if not treated.
Moving the bar forward
Dr. Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill called the approval "a very important step forward," adding that it would be the first rapidly acting antidepressant.
The postpartum period, she continued, was a critical time, and Zuranolone was found to be effective in some trials within three days.
Catherine Monk, professor and chief of the division of women’s mental health in Obstetrics & Gynecology at Columbia University Vagelos College of Physicians and Surgeons, also praised the approval and "Fast-acting" nature of the drug.
Monk did express concern, however, those with mild or moderate postpartum depression should not immediately resort to the drug, since the medication was tested on those with severe postpartum depression, and psychotherapy should be the first response.
Her view was also shared by Judite Blanc, assistant professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine, who explained that Zuranolone “could be particularly beneficial for women who face barriers to accessing long-term treatments, such as low-income women or those with limited healthcare access. However, from a scientific, social, and ethical standpoint, this clinical trial is not the panacea to tackle the maternal health crisis in the U.S. and globally."
She highlighted that “Medications shouldn’t be the first or only line of treatment for mental health conditions, particularly among women, children, and historically oppressed populations."
In addition, Blanc believes there should be more research done among breastfeeding mothers since the trials were mainly conducted on mothers who were not breastfeeding.
She warned that severe depression comes with suicidal ideation and most times a plan to do so. Monk encouraged mothers who feel they need help to seek it.
