- According to the Ministry of Health, an estimated two in 10 women suffer from depression during pregnancy and/or postpartum.
- Previously the only treatment for such conditions was through an IV.
- The most common side effects caused by this new oral therapy were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis and urinary tract infection.
When a woman becomes a mother, there are many feelings that cannot be described in words. Holding a baby in your arms can bring endless joy, but deep down, it’s also the start of a serious problem.it’s about postpartum depression And it’s happening more and more often.
The dark side of being a mother
In this sense, their symptoms were related to sadness and loss of interest in what the woman had done in the past, in addition to increased or decreased appetite and sleep duration. It is also characterized by feelings of guilt, difficulty making decisions, or a belief that the baby is better off without the mother.
When this happens, women often feel hopeless, anxious, and feel that the situation is beyond their reach, that they cannot meet the needs of their baby, or that their tasks are too overwhelming. Sometimes they have negative emotions towards those around them, including their daughter and son.
this depression during pregnancy This resulted in them not being able to attend antenatal medical appointments and eating incorrectly. This can affect the baby’s weight, lead to premature birth and difficulties in parenting, with consequences such as diarrhoea, fever, movement, cognitive, language and social development problems.
according to Ministry of Health (SSa) An estimated 2 in 10 women experience depression during pregnancy and/or postpartum. But what’s more, 75% of them are undiagnosed and therefore not receiving adequate treatment or care.
First drug to fight postpartum depression
Given this situation, it makes perfect sense for the U.S. Food and Drug Administration (FDA) to announce the approval of Zurzuvae (zuranolone), developed by Sage Therapeutics Inc.This is a historical fact because it is The first oral drug to treat postpartum depression.
Today, we approved the first oral medication for the treatment of postpartum depression in adults. https://t.co/z8SD0o2GUV pic.twitter.com/EJzoE73Q79
— US FDA (@US_FDA) August 4, 2023
So far, the only treatment for this condition is through an IV. Instead, now women will be able to rely on another non-invasive alternative.
“Postpartum depression, in addition to its effects on a child’s physical and emotional development, can alter the mother-infant relationship. Access to oral medications will be a beneficial option for many women dealing with extreme emotions,” said FDA’s Center for Drug Evaluation and Research said Tiffany R. Farchione, director of the Division of Psychiatry.
The efficacy of Zurzuvae for the treatment of postpartum depression in adults has been demonstrated in two multicenter, randomized, double-blind, placebo-controlled studies.
clinical trial results
Trial participants were women who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode whose symptoms began in the third trimester of pregnancy or within four weeks of giving birth.
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 at a dose approximately equivalent to Zurzuvae 40 mg or placebo, also for 14 days.
Patients in both studies were monitored for at least 4 weeks after 14 days of treatment. The primary endpoint for both studies was change in depressive symptoms, measured at day 15, using the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
Patients in the Zurzuvae group experienced significant improvement in symptoms compared to the placebo group. On day 42, 4 weeks after the last dose of Zurzuvae, the therapeutic effect was maintained.
The label contains a boxed warning stating that Zurzuvae may interfere with a person’s ability to drive and perform other potentially hazardous activities. Patients may also not be able to assess the extent of their injury. To reduce the risk of injury, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.
The most common side effects included drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. The recommended daily dose of Zurzuvae is 50 mg. Take once daily for 14 days in the evening with a fatty meal.
Finally, this fact offers the possibility now Federal Committee for Health Risk Protection (Cofepris) Amendments were made and authorized in Mexico.
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Postpartum depression: 2 in 10 Mexican mothers suffer from postpartum depression
FDA approves first drug to treat postpartum depression