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US Approves First Postpartum Depression Pill

August 5, 2023
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By Ebi Kesiena

Nursing mothers can now access a pill that treats postpartum depression as health regulators in the United States have approved the first pill to treat postpartum depression.

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According to the Food and Drug Administration (FDA), zuranolone, sold under the brand name Zurzuvae, has been approved as a once-daily pill taken for two weeks.

FDA noted that until now, treatment for postpartum depression (PPD) was available only as an intravenous injection.

Sage Therapeutics and Biogen, manufacturers of the pills noted that the pill is expected to be available later this year, but no price has yet been announced.

Research has found that it is estimated that one in seven women experience symptoms of PPD in the US.

Similar to other forms of depression, symptoms of postpartum depression (PPD) can include sadness, loss of energy, suicidal thoughts, decreased ability to feel pleasure, or cognitive impairment, according to the FDA.

Tiffany Farchione, head of psychiatry in the FDA’s Center for Drug Evaluation and Research noted that postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.

“Postpartum depression is 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,” she said.

Clinical trials showed the pill helped to significantly reduce depressive symptoms within three days. The effect of the medication was maintained at four weeks after the last dose, the FDA said.

It noted that the most common side-effects from taking Zurzuvae can include drowsiness, dizziness, diarrhoea, fatigue, the common cold, and urinary tract infection.

Sage Therapeutics and Biogen said labelling contains a boxed warning noting that Zurzuvae can affect a person’s ability to drive and perform other potentially hazardous activities. It recommends patients should not drive or operate heavy machinery for at least 12 hours after taking it.

The agency has also sought approval to use zuranolone for major depressive disorder (MDD), or clinical depression. However, the FDA said the medication did not provide substantial evidence of effectiveness and said an additional study or studies would be needed.

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