On August 4, the U.S. Food and Drug Administration (FDA) Announcing the approval of Zurzuvae: The first specific oral medication for postpartum depression. It is estimated that this mental disorder can also appear in the final stages of pregnancy and affects 10 to 15% of mothers in Spain. despite this, These percentages may underestimate the real problem: Many cases go undiagnosed or untreated. Although a large portion of society views this phase of life as fulfilling, multiple changes (hormonal, psychological, and social) that come to an end with pregnancy, labor, and the birth of a child can lead to the onset of depression. Happiness.
Common feelings of postpartum anxiety, rejection, and more: “Everyone is celebrating the arrival of my daughter, except me.”
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In addition to the classic symptoms of depression (sadness, inability to experience joy or contentment, feelings of guilt and worthlessness…), psychiatry experts at the FDA’s Center for Drug Evaluation and Research explain that “thoughts” may occur. Harm yourself or your baby. Because postpartum depression can disrupt the mother-infant bond, it can also have an impact on the baby’s physical and emotional development. ” On the other hand, this is a complex issue that not only has individual dimensions but is part of a set of interactions and inequalities, including gender roles, social expectations and systemic dysfunction.
Treatment options for women affected by postpartum depression are limited. On the one hand, there are many difficulties in obtaining early psychotherapy from the public health sector. On the other hand, traditional antidepressants, such as selective serotonin reuptake inhibitors, can take up to 12 weeks to relieve symptoms, sometimes without any benefit to the patient. In 2019, the FDA approved the first fast-acting drug, Zulresso, but it had significant adverse reactions and difficulty in dosing: intravenous administration required a 60-hour hospitalization and required monitoring for possible loss of consciousness or excessive sedation. Currently, the drug is not approved in Europe.
What is Zurzuvae?
The drug’s active ingredient is zuranolone, a modulator of the neurotransmitter GABA (gamma-aminobutyric acid) receptors believed to be involved in major depressive disorder and postpartum depression. Zuranolone is a molecule similar to the hormone allopregnanolone. The latter is a substance produced in the body from the female sex hormone progesterone, the levels of which increase sharply during pregnancy and decline throughout the third trimester before falling sharply after delivery. It is thought that low levels of allopregnanolone may be associated with the development of postpartum depression, although this hypothesis has not been proven and there is considerable controversy in this regard.
What are its benefits and risks?
In clinical trials, patients with postpartum depression showed moderate improvement in their main symptoms starting on the third day of treatment. The improvement was statistically significant compared to a placebo (a substance with no active effect) and lasted a month after they received their last dose of the drug, which lasted 14 days of treatment.
Like all medications, Zurzuvae has many side effects. The most common are: drowsiness, dizziness, sedation, diarrhea, fatigue, nasopharyngitis and urinary tract infections. Like other antidepressants, this drug may cause suicidal thoughts and behaviors in people 24 years of age or younger. Additionally, this drug may impair the ability to drive and perform other potentially hazardous activities, so patients are advised to avoid these activities for at least 12 hours after administration. To alert you to this risk, drug labels include a boxed warning.
How is its effectiveness assessed?
Zurzuvae’s effectiveness has been evaluated in two Phase III clinical trials involving adult women who began to experience severe depression in the third trimester or within one month postpartum. Both studies were conducted at several health centers, including the Hebron Valley University Hospital in Barcelona, and the women were randomly assigned to one of two groups: one received a placebo; . On the other hand, drugs. Neither patients nor health workers administering treatments or assessing patient progress knew what each participant received (double-blind) to avoid possible bias.
Treatment with Zurzuvae lasted 14 days, and patient evaluation was completed 4 weeks after discontinuation of treatment. Improvement in depressive symptoms was studied using the Hamilton Rating Scale, a 17-item scale widely used to quantify the severity of depression.
The unknown behind Zurzuvae
The drug raises several important questions because of limitations in the clinical trials evaluating the drug. First, it’s unclear how effective Zurzuvae is for women with mild or moderate postpartum depression, since it has only been studied in women with the most severe forms. It is possible that the drug may not be recommended for mothers with milder symptoms because it provides little or no benefit while putting them at risk for adverse effects.
Another unknown related information is the long-term effectiveness of the drug, since it was only studied four weeks after stopping treatment. While the drug may cause drowsiness and sedation in some patients, we have no way of knowing how these symptoms may affect a mother’s long-term relationship with her child.
Another open question is whether the drug can cause direct harm to babies, either during pregnancy or while breastfeeding, because this issue was not assessed in the trial (trial participants were given formula). Therefore, women should avoid breastfeeding and use birth control while taking Zurzuvae and for one week after the last dose.
It is not yet known when, or if, the drug will arrive in the EU. In fact, its intravenous equivalent was approved in the United States in 2019 but has yet to reach Europe.
The complexities of postpartum depression
Judite Blanc, a professor of psychiatry at the University of Miami, recalled in an article published in The New York Times. Today’s Medicine Page Postpartum depression “is not just a personal or biological problem, but the result of a complex interplay between gender roles, social expectations, and systemic inequalities.” Therefore, social factors such as lack of family or partner support or sexist violence may Increases the risk of developing this disease. “When do we begin to address the social determinants of postpartum depression and maternal mortality?” Blank asked in an article published in the medical journal JAMA that evaluated the effectiveness of new treatments in the United States. Pros and cons.
In this sense, drugs like zuranolone are “just a layer” of protection against this type of depression, which to this day remains invisible. However, the emergence of such drugs with better therapeutic efficacy may help doctors better detect postpartum depression.