FDA Approves First Postpartum Depression Pill in US: What to Know

Labeling of the drug says it could spark suicidal thoughts and cause fetal harm

A father and a mother look at their newborn son at the maternity of the Diaconesses hospital in Paris, on Nov. 17, 2020. Martin Bureau/AFP via Getty Images

The U.S. Food and Drug Administration has for the first time approved a pill to treat postpartum depression, a condition that affect millions of mothers.

Until now, treatment for postpartum depression in the United States was available only as an IV injection that could be given by a health care provider in certain health care facilities.

The new pill, called Zurzuvae, from Biogen and Sage Therapeutics, is to be taken once a day for 14 days in the evening with a fatty meal. It is indicated for mothers experiencing severe depression related to childbirth or pregnancy.

“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,” Dr. Tiffany R. Farchione, the FDA’s director of psychiatric drugs, said in a statement.

“And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Postpartum depression affects around one in seven women who give birth.

As with other forms of depression, postpartum depression is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure, according to the FDA.

“It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy or suicidal ideation,” the agency said in a release.

In 2021, an estimated 21.0 million adults in the United States had at least one episode of major depressive disorder, which is characterized by a persistent feeling of sadness.

Could Cause Fetal Harm: Label

The FDA’s pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill.

The benefits, measured using a psychiatric test, appeared within three days for many patients.

The labeling of Zurzuvae (pdf) contains a boxed warning saying the drug can impact a person’s ability “to drive and engage in other potentially hazardous activities.” It notes that patients “may not be able to assess their own driving competence or the degree of impairment” and that to reduce the risk of harm, patients are advised not to engage in such activities until at least 12 hours after taking the pill.

The most common side effects of Zurzuvae include drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection.

The label warns that use of Zurzuvae may also cause “suicidal thoughts and behavior,” and in such cases, patients should change the therapeutic regimen, which may include stopping taking the pill.

It further warns that Zurzuvae “may cause fetal harm.”

“Advise a pregnant woman of the potential risk to an infant exposed to Zurzuvae in utero,” the label reads. “Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during ZURZUVAE treatment and for one week after the final dose.”

A pregnant woman holds her stomach in Sydney, Australia, on June 7, 2006. Ian Waldie/Getty Images

Sage Therapeutics has a similar infused drug that’s given via IV injection over three days in a medical facility. The FDA approved that drug in 2019, though it isn’t widely used because of its $34,000 price tag and the logistics of administering it.

Both the pill and IV forms mimic a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy. Levels of the hormone can plunge after childbirth.

Sage’s drugs are part of an emerging class of medications called neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions.

The Associated Press contributed to this report.