The Food and Drug Administration (FDA) has approved the first medication designed to treat postpartum depression. According to a statement released Tuesday, the medication, which reportedly has an immediate effect, will be available as brexanolone injections.
To receive treatment, patients must enroll in a restricted program, named the Zulresso REMS Program, which requires the injections to be administered by a healthcare provider in a certified healthcare facility over a 60-hour period or two and a half days.
"Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood)," the FDA said.
Participants in the program will be closely monitored for side effects. The drug reportedly works so quickly that patients can expect to see improvement within 48 hours. Given that most antidepressants must build up in the system for weeks before any effects are noticeable, Zulresso is a breakthrough for mothers whose postpartum depression is interfering with their ability to care for their newborns and themselves.
The FDA has approved a new medication called Zulresso, a completely new class of drug designed specifically to treat postpartum depression. @kristendahlgren has the details: https://t.co/869UdBtjWB pic.twitter.com/izvU7xogaM— NBC Nightly News with Lester Holt (@NBCNightlyNews) March 19, 2019
"Postpartum depression is a serious condition that, when severe, can be life-threatening," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Women may experience thoughts about harming themselves or harming their child."
The American Psychological Association estimates that 1 in 7 women experience postpartum depression during their lifetime. Not to be confused with the "baby blues," which are fleeting, postpartum depression may appear within days or even months of giving birth and can last indefinitely if left untreated. The illness can have damaging consequences, which is why seeking professional immediately is crucial.
In addition, postpartum depression doesn't discriminate, affecting mothers of any age, race, or ethnicity, as well as first-time mothers or mothers with several children. The announcement of the breakthrough has gone viral on the internet with many women grateful that a solution will finally be available.
"What wonderful news for women and their families!" wrote one Facebook user, while another added, "What a difference this would have made in '74."
Postpartum depression affects nearly one in nine mothers after childbirth. Zulresso would be the first drug dedicated to treating the mental illness: https://t.co/OrpX7ndrYn— WBUR (@WBUR) March 20, 2019
The cost of the treatment, however, had shocked many. Marketed by Sage Pharmaceuticals, the injections cost $34,000 per patient. In addition, patients must cover the cost of a two-day medical stay. "After horrendous PPD and PPA this is amazing," wrote another Facebook user. "But I couldn’t afford this. It makes me sad how hard and how expensive health care is."
"No one in their right mind can afford this!" wrote another. "This is like dangling a carrot in front of a horse. I know your [sic] hungry, I hear you but haha ya can’t reach it."
Fortunately, health officials expect insurance companies to cover the treatment, though the drug, as well as the parameters of the treatment, are still being evaluated to determine if it will be subsidized. Meanwhile, Sage Pharmaceuticals hopes another postpartum depression treatment, which is currently in clinical trials, will be more affordable and accessible for future patients. It could take a couple of years for the treatment to be approved by the FDA, but it would be available in pill form.