- According to the Ministry of Health, it is estimated that two out of 10 women develop depression during pregnancy and/or postpartum.
- The only treatment previously available for this type of situation was through an intravenous injection.
- The most common side effects caused by this new oral treatment are drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
When a woman becomes a mother, multiple feelings are generated that cannot be described in words. Having the baby in her arms causes infinite joy and although deep down it is also the beginning of a serious problem. It’s about the Postpartum depression and it is becoming more frequent.
The dark side of becoming a mother
In this sense, their symptoms have to do with sadness and loss of interest in things that women used to do, in addition to increased or decreased appetite and hours of sleep. It is also characterized by generating feelings of guilt, difficulty making decisions, or the idea that the baby could be better off without her mother.
When it occurs, women commonly feel hopeless, anxious, that circumstances are beyond them, that they are unable to take care of their baby’s needs, or that their tasks are overwhelming. Sometimes they experience negative feelings for those around them, including their daughter and son.
The depression in pregnancy It causes them not to attend prenatal medical appointments and they do not eat properly. This will affect the weight of the baby, can cause premature labor and difficulty in the parenting process with consequences such as diarrhea, fever, motor, cognitive, language and social development problems.
According to the Ministry of Health (SSa) It is estimated that two out of 10 women develop depression during pregnancy and/or postpartum. But something that is too serious is that 75 percent of them are not diagnosed and therefore do not receive adequate treatment or care.
First pill against postpartum depression
Given this scenario, it is highly relevant that the United States Food and Drug Administration (FDA) announced the approval of Zurzuvae (zuranolone), developed by Sage Therapeutics Inc. It is a historical fact because it is the first oral medication indicated to treat postpartum depression.
Today, we approved the first oral medication indicated to treat postpartum depression in adults. https://t.co/z8SD0o2GUV pic.twitter.com/EJzoE73Q79
—US FDA (@US_FDA) August 4, 2023
Until now, the only treatment available for this type of situation was through an intravenous injection. Instead, now women will be able to count on another alternative that is not invasive.
“Postpartum depression can alter the maternal-infant bond, in addition to having consequences for the physical and emotional development of the child. Having access to an oral medication will be a beneficial option for many of these women dealing with extreme feelings,” said Tiffany R. Farchione, who is director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research.
The efficacy of Zurzuvae for the treatment of postpartum depression in adults was demonstrated in two multicenter, randomized, double-blind, placebo-controlled studies.
Results of clinical trials
Trial participants were women 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 Zurzuvae 50 mg or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to Zurzuvae 40 mg or placebo, also for 14 days.
Patients in both studies were monitored for at least four weeks after the 14-day treatment. The primary endpoint of both studies was change in depressive symptoms using the 17-item Hamilton Depression Rating Scale (HAMD-17) total score, measured at day 15.
Patients in the Zurzuvae groups showed significantly greater improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at day 42, four weeks after the last dose of Zurzuvae.
The label contains a boxed warning stating that Zurzuvae may affect a person’s ability to drive and perform other potentially hazardous activities. Patients may also not be able to assess their degree of impairment. To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.
The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. The recommended daily dose of Zurzuvae is 50 mg. It should be taken once a day, for 14 days, in the evening with a fatty meal.
Finally, this fact opens the possibility for now the Federal Commission for the Protection against Sanitary Risks (Cofepris) make the pertinent revisions and also be authorized in Mexico.
Also read:
Hyperhidrosis, a condition that can lead to depression
Postpartum depression: 2 out of 10 Mexican mothers develop it
FDA approves first drug for postpartum depression