The U.S. Food and Drug Administration (FDA) on Friday approved a drug called ” Zuranosaurus For the treatment of major depressive disorder and severe postpartum depression.
It is the first oral drug approved by the FDA for the treatment of postpartum depression, a serious mental illness that affects one in seven new mothers after childbirth.
The drug, which will be sold under the brand name Zurzuvae, will be taken once daily for 14 days, the FDA explained.
“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 children,” the health agency said in a statement.
Consequences of postpartum depression
Tiffany R. Farchione, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said postpartum depression “can disrupt the mother-infant relationship.”
“Access to oral medications will be a beneficial option for many women who are dealing with extreme and sometimes life-threatening sensations,” Facione added.
The FDA added a boxed warning to the drug’s label stating that the drug may impair a person’s ability to drive or engage in other “potentially” hazardous activities.
secondary impact
Side effects of the pill will be: drowsiness, dizziness, diarrhea, fatigue, cold or urinary tract infection, the agency noted.
Patients also may not be able to “assess” the extent of their injury, the FDA explained. “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.”
Use of this drug may also cause suicidal thoughts or actions, or possible harm to a fetus.
Women should use effective birth control while taking the pill and for a week after taking it, the agency said.
Postpartum depression can last for years
It is estimated that more than 400,000 babies are born to depressed mothers in the United States each year. Postpartum depression can linger for months or years, according to the National Institute of Mental Health.
Treatment options for postpartum depression include counseling or therapy with a mental health professional and antidepressant medications, but prior to Zulresso and zuranolone, the FDA had not approved any antidepressants specifically for the treatment of postpartum depression.
In general, antidepressants do not provide immediate relief from postpartum depression symptoms and may take several weeks to work.
