This medicine is taken once daily for 14 days. The most common side effects include drowsiness, dizziness, diarrhea, fatigue, common cold, and urinary tract infections.
Courtesy of CNN Spanish | The drug’s approval is a major milestone in the treatment of postpartum depression
The U.S. Food and Drug Administration (FDA) has approved the drug zuranolone to treat postpartum depression, making it the first oral drug approved to treat a serious mental illness that about one in seven new mothers may experience after giving birth. suffer from this disease.
The treatment, which will be marketed under the brand name Zurzuvae, has been approved as a once-daily pill for 14 days, the FDA announced.
“Postpartum depression is a serious and life-threatening condition in which women experience feelings of sadness, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their baby. Because postpartum depression can disrupt the mother-baby relationship, it It can also have an impact on a child’s physical and emotional development,” said Tiffany R. Farchione, MD, director of the Division of Psychiatry in the FDA’s Center for Evaluation and Investigation of Drugs.
“Access to oral medications will be a beneficial option for many women who are dealing with extreme and sometimes life-threatening sensations,” she added.
The FDA added a boxed warning to the drug’s label stating that it may affect a person’s ability to drive and perform other potentially dangerous activities.
Patients may also not be able to assess the extent of their injury. To reduce the risk of injury, the agency says patients should not drive or operate heavy machinery for at least 12 hours after taking the drug.
The most common side effects included drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold) and urinary tract infection, the FDA said.
The agency also said use of the drug may lead to suicidal thoughts and behaviors. It may also cause harm to a fetus.
Women should use effective birth control while taking the pill and for a week after taking it, the agency said.
Women with severe postpartum depression may develop suicidal ideation, and suicide accounts for approximately 20% of all postpartum deaths.
It is estimated that more than 400,000 babies are born to depressed mothers in the United States each year. Without any treatment, postpartum depression can linger for months or even years, according to the National Institute of Mental Health.
raised concerns
Catherine Monk, chair and professor of women’s mental health in the Division of Obstetrics and Gynecology, said the drug’s approval is an important milestone for treating postpartum depression, especially because it has a new biological target and works quickly. Columbia University Vagelos College of Physicians and Surgeons.
However, she added that some maternal mental health experts have concerns about zuranolone: The drug was initially tested primarily in women with severe postpartum depression, rather than mild or moderate depression, and patients should still consider psychotherapy. Treatment as an intervention for depression.
“There are concerns that this drug will work for everyone. And for people with mild to moderate depression, the gold standard of treatment is to start psychotherapy and other behavioral and lifestyle changes,” Monk said, adding that for mild For women with moderate to moderate postpartum depression, birth control pills should not be the first response.
“It should be clear that it was initially determined to be effective primarily in people with major depressive disorder,” he said.
“Additionally, there are significant health disparities in the incidence of postpartum depression, with rates being much higher among poor and minority populations.”
While this disparity is a sociopolitical issue, “we must address the social determinants of health in the causal pathways of postpartum depression and not let the excitement of new drugs overshadow these issues,” Monk said.
Judit Blank, an assistant professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine, has a similar take.
Zuranolone “is particularly beneficial for women who face barriers to long-term treatment, such as low-income women or women with limited access to health care. However, from a scientific, social, and ethical standpoint, this clinical trial is not a solution to the U.S. and a panacea for maternal health crises around the world,” Blank wrote in an email last month.
“Medicine should not be the first or only line of treatment for mental health issues, especially for women, children and historically oppressed populations,” she said.
Since the zuranolone effects reported in the trial were only followed for 45 days in non-breastfeeding postpartum women, Blanc added, “More studies are needed to assess the long-term effects of zuranolone, including in breastfeeding mothers such as patients – Baby interaction.
Symptoms of postpartum depression include frequent crying, difficulty bonding with your baby, trouble sleeping, or feeling hopeless.
Women with severe postpartum depression who are unable to go about their daily lives and often have recurring thoughts of suicide, harming themselves, or their baby are very serious symptoms that require immediate evaluation and attention.
“People with major depression tend to be suicidal and have a very worrisome plan,” Monk said.
But she added that for any new mother, “If you feel like you need some support and help, even if you have what we call subclinical depression, it’s okay, reach out, you deserve help, and it probably is. You don’t need as much help as other people with very severe depression, but let’s get the support and help you need, especially to keep it from getting worse.”
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