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Zurzuvae oral drug PPD

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FDA approves oral pill to fight postpartum depression

Response to the news from local birth professionals is mixed

Intrusive thoughts, obsessive thinking, erratic behavior, an inability to sleep . . . 

In the U.S., 1 in 7 (15%) women experience one or all of these classic symptoms of postpartum depression (PPD) in the days, weeks, and months after giving birth. 

At a time when they expect to experience joy, curiosity, and hope, these parents instead struggle with anxiety, lethargy, and fear. As with other forms of depression, PPD is punctuated by a loss of interest in activities one used to enjoy and a decreased ability to feel pleasure. It can also cause cognitive impairment, feelings of sadness or inadequacy, loss of energy, or suicidal ideation. 

Hope for PDD sufferers

Imagine being able to take one pill a day for 14 days to reduce or effectively stop the flow of PPD. 

You don’t have to imagine. This week the U.S. Food and Drug Administration (FDA) approved Zurzuvae (zuranolone), an oral medication, to treat PPD. Studies show that the pill may help parents feel better within days – far faster than the one to three months it can take for other antidepressant medications or talk therapy to kick in. Zuranolone is the first oral medication approved to fight severe depression and anxiety after a baby’s arrival, www.sleepmedsite.com/page/sc/our_services/klonopin_clonazepam. Until now, the only other drug targeted explicitly at PPD was Zulresso, an IV injection given by a healthcare provider in a medical facility.

“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,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research in a release about the agency’s approval of quinolone. “And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”

Birth professionals raise concerns 

Still, while the FDA ruling offers hope to new parents impacted by depression, those who work with families during the perinatal period in the Puget Sound are concerned about the drug’s impact on breastfeeding and birth/postpartum care and support for families.

“Medicine is great and all but does not take the place of good policy…insurance, maternity and paternity leave, breastfeeding support and child care,” says Kelle Baxter, ARNP, a family nurse practitioner at Swedish Medical Center.

Zoe Ruaboro, IBCLC, a lactation and postpartum support provider based in Auburn, says she’s concerned the medication may become “just another out for society to take instead of actually supporting new mothers, changing the way we birth, and family dynamics.

“I sincerely hope people benefit from this, and maybe it is a step in the right direction, but I don’t know,” says Ruaboro. “I just imagine another impersonal six-week OB visit: ‘You’re welcome to resume normal activities . . . Oh, you’re having a hard time? Just take this little pill.”

“I’d love it if, over the years, my opinion changes, though,” Ruaboro added.

Good news, but . . .

Dr. Leslie Butterfield, a Seattle-based clinical psychologist specializing in pre and perinatal psychology and women’s health, is hopeful but cautious.

“Clearly, the possibility of taking a pill once a day for two weeks and feeling significantly better for a long time (current research ends at the 45-day point) is really good news,” Butterfield says. 

But: “We need more data on whether that improvement continues after the 45-day point, or whether people should plan on needing to take refreshers of the meds later on down the line,” Butterfield says. “I think it would be fine to require a refresher— that is hardly a game-stopper — but it would be important information. This is a very targeted biological approach, and we certainly need to keep collecting data on long-term efficacy.”  

The drug was developed by Sage Therapeutics and Butterfield says that it “works very differently than SSRIs as it targets GABA, the main neurotransmitter in the nervous system.

“I haven’t seen any reports about the new med that reference this difference, [but] I’d be interested in such information,” she adds.

The big question: What’s the impact on breastfeeding and babies?

Butterfield, Seattle lactation consultant Rene Bebee, IBCLC, and others also are concerned about zuranolone’s impact on breastfeeding and the bonding relationship that breastfeeding can promote. According to animal studies, zuranolone may cause fetal harm when administered to a pregnant woman. The medication passes into breastmilk, but there is no data on the effects of zuranolone on a breastfed infant and limited data on the impact on milk production. 

“There is a need for research to be done concerning the impact on breastfeeding,” says Butterfield. “Since this is touted as a drug specifically geared toward postpartum depression, it behooves the company to gather breastfeeding-related information as quickly as possible, especially because we know that breastfeeding has its own impact on depression and anxiety.”

Warning label

Butterfield points out the drug also has a “black box” warning label. 

“It is unclear to me exactly what issues fall under the black box and what issues need to be watched,” says Butterfield. “I know that possible suicidal thoughts and behaviors, sleepiness, and confusion are warned against.” Those taking the medication are also warned not to drive due to sedating effects.

According to the FDA release: “Use of Zurzuvae may cause suicidal thoughts and behavior. Zurzuvae may cause fetal harm. Women should use effective contraception while taking, and for one week after taking, Zurzuvae.”

 Study results

Researchers conducted two randomized, double-blind, placebo-controlled, multicenter studies of Zurzuvae. The trial participants were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery. 

In Study 1, patients received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another quinolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also for 14 days. 

Patients in both studies were monitored for at least four weeks after the 14-day treatment. Patients in the Zurzuvae groups showed significantly more symptom improvement than those in the placebo groups. The positive effect of the medication lasted for at least 42 days —four weeks after the last dose of Zurzuvae.

Kate Dewey, who provides doula and other services, says she, too, worries about the medication’s impact on lactation and its implications for perinatal support policymaking. At the same time, she says, zuranolone could, in fact, be a game changer for many who suffer from PPD: 

Says Dewey: “I saw this as a literal lifesaving option for people who are suffering and do not have all of those lovely privileges that we say people need like helpful support people, access to mental health care, the financial stability required to hire a house cleaner and a positive birth experience.”

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About the Author

Cheryl Murfin

Cheryl Murfin is managing editor at Seattle's Child. She is also a certified doula, lactation educator for NestingInstinctsSeattle.com and a certified AWA writing workshop facilitator at Compasswriters.com.