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New Federal Approval for Postpartum Depression Pill

Analysis by Dr. Joseph Mercola Fact Checked

postpartum depression pills

Story at-a-glance -

  • The first drug to treat postpartum depression has been approved by the U.S. Food and Drug Administration (FDA), but there are serious questions about whether this medication will truly help new moms in need
  • The drug, Zulresso (brexanolone), is administered as an IV infusion over 60 hours (2.5 days) and costs $7,450 per vial, or from $20,000 to $34,000 per treatment
  • Zulresso can cause a sudden loss of consciousness and can only be administered by a health care provider in a certified health care facility
  • Psychotherapy, or talk therapy, is considered the first-line treatment option for women with mild to moderate postpartum depression; another alternative therapy is transcranial magnetic stimulation, which involves using magnetic fields to stimulate nerve cells in the brain
  • Exercise, mindfulness, nutritional strategies and practicing self-compassion can also reduce PPD symptoms, but if you’re having thoughts of harming yourself or your infant, you should seek emergency medical help

The first drug to treat postpartum depression has been approved by the U.S. Food and Drug Administration (FDA), but there are serious questions about whether this medication will truly help new moms in need. Postpartum depression (PPD) affects about 1 in 9 women1 in the days and weeks following childbirth, although for some the symptoms begin during pregnancy.

By some estimates, the prevalence of depression among women during their first year postpartum may be close to 22 percent,2 but rates of diagnosis and treatment are low — even more so in pregnant and postpartum women than in the general population.3

Effective and safe forms of treatment are urgently needed, but it's doubtful they'll be found in the form of Zulresso (brexanolone) — a costly intravenous medication that's known to cause loss of consciousness, which means it can only be administered under direct medical supervision.

Zulresso Costs Up to $34,000, May Cause Loss of Consciousness

The FDA approved Zulresso under its priority review program, which means it received a response within six months instead of the typical 10-month review period.4

The drug will only be available via a restricted program called the Zulresso Risk Evaluation and Mitigation Strategy (REMS). The program requires the drug to be administered by a health care provider in a certified health care facility, and patients must be enrolled in the REMS program before receiving the drug.

The restrictions are due to the fact that Zulresso can cause a sudden loss of consciousness, which means patients must be closely monitored while receiving the drug. Zulresso is administered as an IV infusion over 60 hours (2.5 days). According to the FDA:5

"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). While receiving the infusion, patients must be accompanied during interactions with their child(ren).

The need for these steps is addressed in a Boxed Warning in the drug's prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion.

Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away."

In addition to loss of consciousness, Zulresso can also cause dry mouth, sleepiness and flushing. The FDA described two clinical studies of Zulresso, in which patients with either severe or moderate PPD received the drug or a placebo and were followed for four weeks.

In both cases, those receiving the drug had a greater reduction in depressive symptoms compared to placebo, with improvements noted at the end of the first infusion as well as at the end of the 30-day follow-up period.

The treatment is making headlines not only because it's the first medication approved for PPD but also because of its cost, which is listed at $7,450 per vial, or from $20,000 to $34,000 per treatment, according to its maker, Sage Therapeutics.6 This is on top of the cost of the medical center stay required for its administration.

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'The Most Common Pregnancy Complication'

In an email to PBS, Camille Hoffman, an assistant professor of maternal fetal medicine at the University of Colorado School of Medicine, labeled PPD as the most common pregnancy complication.7 It's associated with lower rates of breastfeeding, poor bonding between mother and baby and developmental disorders in the infant.8

While up to 80 percent of new moms experience what's known as the "baby blues" postpartum,9 which may involve mood swings, anxiety, irritability, crying and sadness, the feelings are self-limiting and typically resolve after a few weeks.

This isn't the case with PPD, which may cause anxiety, guilt, fatigue and feelings of inadequacy that persist for a year or more. In severe cases, a woman may become withdrawn from her child or harm herself or the baby. Additional symptoms may include the following (women may have some or all of these symptoms):10

Depressed mood or severe mood swings

Excessive crying

Difficulty bonding with your baby

Withdrawing from family and friends

Loss of appetite or eating much more than usual

Inability to sleep (insomnia) or sleeping too much

Overwhelming fatigue or loss of energy

Reduced interest and pleasure in activities you used to enjoy

Intense irritability and anger

Fear that you're not a good mother

Feelings of worthlessness, shame, guilt or inadequacy

Diminished ability to think clearly, concentrate or make decisions

Severe anxiety and panic attacks

Thoughts of harming yourself or your baby

Recurrent thoughts of death or suicide

It's unknown why some women develop PPD, but there are known risk factors, including depression during or before pregnancy, family history of depression, lack of or low social and emotional support, experiencing stressful life events during pregnancy or having a premature birth or traumatic birth experience.11,12

As for its cause, multiple factors, including physical, emotional and environmental, likely play a role and may be compounded by the hormonal changes that occur after childbirth. According to the National Institute of Mental Health:13

"After childbirth, the levels of hormones (estrogen and progesterone) in a woman's body quickly drop. This leads to chemical changes in her brain that may trigger mood swings.

In addition, many mothers are unable to get the rest they need to fully recover from giving birth. Constant sleep deprivation can lead to physical discomfort and exhaustion, which can contribute to the symptoms of postpartum depression."

There is also research that shows PPD is associated with the administration of oxytocin during childbirth, a common practice as oxytocin (and its man-made alternatives like Pitocin) stimulates contractions and is often used to induce labor.

"It is possible that oxytocin administered during childbirth is related with the onset or worsening of the PPD," at least one study concluded, so this is another factor to take into account, especially if you're already at increased risk of this condition.14

Research Into Alternative Therapies for PPD Lacking

It's clear that women suffering from PPD need avenues for effective treatment. Suicide accounts for 20 percent of postpartum deaths and researchers found that, in a screening of 10,000 new mothers for PPD, 14 percent were positive for PPD.15

Of these, more than 19 percent had self-harm ideation, all of whom scored 10 or higher on the Edinburgh Postnatal Depression Scale (EPDS), the most common tool used to screen for PPD. That being said, a literature review revealed that studies into complementary options for treating PPD are "severely lacking" and "research is needed to help identify cost-effective alternative therapies for treating postpartum depression."16

The fact is, many women who are suffering may not be in the position to receive treatment via a $34,000 IV infusion in a medical center. Others may not want to use drug-based treatments as they're concerned about the side effects or exposure of their infant if they're breastfeeding.17

The review, published in Nursing for Women's Health, explained, "Combined with prevention and screening, treatment options that suit women's varied situations and preferences must be explored to increase reception and adherence to treatment and, ultimately, to improve outcomes."18

Psychotherapy, or talk therapy, is considered the first-line treatment option for women with mild to moderate PPD.19 Another alternative therapy is transcranial magnetic stimulation, which involves using magnetic fields to stimulate nerve cells in the brain. The procedure has been found to treat PPD symptoms as well as lead to significant improvement in bonding between mothers and infants.20

"There is a growing evidence base for nonpharmacologic interventions including repetitive transcranial magnetic stimulation, which may offer an attractive option for women who wish to continue to breastfeed and are concerned about their infants being exposed to medication," researchers wrote in the Journal of Midwifery & Women's Health.21

Strategies for Optimizing Your Metal Health After Childbirth

If you're a new mom and are having suicidal thoughts or thoughts of harming your baby, seek help immediately. If you're in the U.S., call 911 or the National Suicide Prevention Lifeline at 1-800-273-TALK (1-800-273-8255).

If you're feeling depressed and aren't sure if it's PPD or postpartum baby blues, talk with your family, therapist and your doctor as soon as possible. It's important not to suffer in silence. As you seek help from a mental health professional, you can also support your recovery and optimize your mental health after childbirth using the following natural strategies:

Increase your omega-3 intake — A study has shown that insufficient dietary intake of omega-3s may increase a woman's risk of postpartum depression.22 You can get omega-3s from foods like wild Alaskan salmon and small fish like sardines and anchovies. Supplementing with high-quality krill oil is also recommended.

Exercise — Exercise is known to help relieve depression, and research also shows that light-to-moderate intensity exercise improves mild-to-moderate depressive symptoms and increases the likelihood that the depression will resolve during the postpartum period.23

A meta-analysis also revealed that exercise both during pregnancy and in the postpartum period may lead to better psychological well-being and reduce PPD symptoms.24

Practice mindfulness before and during birth. Research suggests mindfulness training that's tailored to address the fear and pain of childbirth offers many mental health benefits to new moms, including the prevention of PPD.25

Emotional-based strategies, such as helping moms have a more self-compassionate attitude toward themselves, appear to be important in relieving PPD symptoms.26

Further, women with dysfunctional beliefs about motherhood are also more at risk,27 whereas acceptance-focused processes, including nonjudgmental appraisal of thought content and psychological flexibility, and self-compassion are protective.28

Get vitamin B2 — It may decrease your risk of PPD if consumed in moderation.29

Breastfeed your baby — There is some research linking the discontinuation of breastfeeding and formula feeding with PPD,30 while women who breastfeed their infants reduce their risk of developing PPD.31

Zulresso may be the first drug treatment for PPD, but it's unlikely to be the last. Already, Sage Therapeutics is working on developing another "blockbuster" PPD drug in the form of a once-daily pill.32

Fortunately, research into nondrug solutions is also on the rise, with promising results even stemming from self-guided, web-based interventions such as Be a Mom, which is aimed at enhancing women's emotion regulation abilities and self-compassion.33

Strategies for tending to your emotional health, including the Emotional Freedom Techniques (EFT), are always important, but they're especially important to be aware of if you're pregnant, planning to become pregnant or have recently had a baby.