The US Food and Drug Administration (FDA) has approved the first pill to treat postpartum depression (PPD)– a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy.
Australian and international research suggest that around 15-22 per cent of women experience depression during pregnancy and/or following the birth of their baby. And up to 1 in every 5 women may experience symptoms of anxiety, depression or both during pregnancy and/or following birth.
Explaining the severity of postpartum depression, M.D., director of the Division of Psychiatry in the FDA’s Centre for Drug Evaluation and Research, Tiffany R. Farchione said in a statement that it’s “a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness– even, in severe cases, thoughts of harming themselves or their child.”
“And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”
Now, the FDA has approved a once-a-day-pill, called zuranolone, for use in adults with postpartum depression. Before this, the only approved option for treating the condition was to have an IV infusion of brexanolone, a treatment approved by the FDA in 2019.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” said Dr Farchione.
The pill is meant to be taken for two weeks, and the labeling on the box of Zurzuvae (the branded name of zuranolone) contains a warning that it can impact a person’s ability to drive and perform other potentially hazardous activities.
The efficacy of the pill was demonstrated in two randomised, double-blind, placebo-controlled, multicentre studies, with patients in the Zurzavae groups showing significantly more improvements in their symptoms compared to those in the placebo groups.
The FDA says the most common side effects of the drug include drowsiness, dizziness, diarrhoea, fatigue, the common cold and urinary tract infection as well as a risk of suicidal thoughts. The drug may also cause foetal harm, so the FDA recommends women taking it to use contraception.
Drug companies have said the pill will need to clear a 90-day Drug Enforcement Administration scheduling process before it can enter the market.
According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality, with PPD among the most common complications during and after pregnancy.
Ph.D., PMH-C, Executive Director at Postpartum Support International said the approval of the first pill to treat PPD “is welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year.”
“Women with PPD desperately need prompt care and additional treatment options that can provide quick relief so they can be healthy and present during this momentous time in their lives.”