The U.S. Food and Drug Administration (FDA) has approved the first breakthrough pill to treat postpartum depression (PPD), the agency said in a press release Friday.
The Sage Therapeutics product Zurzvae (Zranolone) is designed to address “depressive episodes that usually occur after childbirth but can also begin later in pregnancy.” according to FDA.
The tablet, which replaces traditional IV injection therapy for PPD, continues to be marketed.
“Postpartum depression is a serious and potentially life-threatening condition,” said Dr. Tiffany R. Falchione of the FDA.
PPD can cause women to “experience feelings of grief, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their children,” Dr. Falchione continued, adding that “the child’s physical can also affect emotional development,” he said.
Drunk flies can affect a person’s ability to drive and perform other potentially dangerous activities, according to the FDA, with warnings on drug labels. #postpartum depression https://t.co/9gbtGyjqUi
— IE Lifestyle (@lifestyle_ie) August 5, 2023
Zurzvae was successfully tested in two 14-day studies of women with PPD, officials said in a statement.
The pills have side effects and “can affect your ability to drive and perform other potentially dangerous activities,” the agency said. It is to be taken at 50 mg daily for 14 days and will continue to be on sale.
According to the FDA, “Patients should not drive or operate heavy machinery for at least 12 hours after taking the dung fly.” (Related: Shortly after GOP’s expanded access proposal, FDA quietly allows drug companies to profit from life-saving diabetes treatment)
The price of the tablets remains unknown. Dr. Kimberly Yonkers of Yale University said it could be prescribed to women who have failed treatment with antidepressants. Said Associated Press.
