FDA Approves First Postpartum Depression Drug, But Access Is An Issue

With Jane Clayson

Postpartum depression can be life-threatening. We look at a new drug just approved by the FDA and other efforts to help new mothers in distress.

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Guests

Dr. Samantha Meltzer-Brody, professor of mood and anxiety disorders at the University of North Carolina, Chapel Hill. Primary investigator of Sage Therapeutics’ Zulresso (brexanolone) injection for the treatment of postpartum depression. Director of the Perinatal Psychiatry Program at the UNC Center for Women’s Mood Disorders. (@smeltzerb)

Dr. Kimberly Yonkers, professor of psychiatry, epidemiology, obstetrics, gynecology and reproductive sciences at the Yale School of Public Health. (@YaleSPH) Director of Yale’s Center for Wellbeing of Women and Mothers.

Jennifer Block, journalist who focuses on women, health and power. Author of the forthcoming book “Everything Below The Waist: Why Health Care Needs a Feminist Revolution” and “Pushed: The Painful Truth About Childbirth and Modern Maternity.” (@writingblock)

From The Reading List

New York Times: “Opinion: It Will Take More Than a $34,000 Drug to Stop Postpartum Depression” — “The Food and Drug Administration last week approved the first-ever drug specifically for postpartum depression. The drug, Zulresso, a synthetic form of a hormone produced in the brain, acts quickly, and its effects can last for a month, but there’s a catch.

“Until a pill version is approved, the patient has to be hospitalized for 60 hours and receive the drug by IV. She can’t be home with her new baby because the drug may cause dizziness and unconsciousness. The price is also dizzying: $34,000 per treatment.

“Zulresso showed enough promise in clinical trials to warrant speedy review and approval, but there was also a powerful placebo effect: While the depression scores of severely depressed women who received the drug dropped by two-thirds on average in one of the trials, the scores of those who got a sham treatment were cut in half. A big placebo effect is common in antidepressant studies, but it should not be overlooked, because it may be emblematic of one of the root causes of our postpartum despair epidemic. What new mother wouldn’t have an improved outlook after three days of TLC?

“Postpartum depression is a serious problem, affecting, by some estimates, one in nine American mothers. It can be incredibly painful and is believed to be a growing cause of maternal deaths in the year following a birth. Insurers are expected to cover the exorbitant cost of Zulresso, which suggests that there’s finally a will to address our country’s dismal record on maternal health. Hurray!”

NPR: “New Postpartum Depression Drug Could Be Hard To Access For Moms Most In Need” — “One in nine women in the United States suffer from depression after childbirth. For some women, postpartum depression is so bad that they struggle to care for their children and may even consider or attempt suicide.

“This week, the Food and Drug Administration approved a new drug that can help, the first drug approved specifically for postpartum depression. While researchers and clinicians are excited about the drug’s potential, some foresee obstacles to making it available to women who need it the most.

“Postpartum depression is more common among women from lower socio-economic groups, yet the drug, which comes with a $34,000 price tag and requires a stay in a healthcare facility, could be out of reach for many of these women.

“‘Those who have the highest rates of postpartum depression and who would benefit the most, I fear it will be limited access to them,’ says Dr. Maria Muzik, an associate professor at the department of psychiatry and obstetrics and gynecology at the University of Michigan.

“And there will likely be logistical hurdles in delivering the drug, adds Muzik, because it has to be given via a one-time continuous IV infusion over 60 hours under medical supervision at a hospital or another medical facility.”

PBS NewsHour: “What we know about the FDA’s new postpartum depression drug” — “Postpartum depression is a common complication after birth, affecting hundreds of thousands of American women every year. A new treatment could offer much-needed help to some new mothers with this disorder, but questions remain about how affordable or accessible it will be.

“The nation’s first medication designed to treat postpartum depression was approved by the Food and Drug Administration on Tuesday.

“The new drug is ‘an important new treatment option,’ said Tiffany Farchione, who directs the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a released statement. Here’s what we know.”

Brian Hardzinski produced this hour for broadcast.

This article was originally published on WBUR.org. [Copyright 2019 NPR]