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The US Food and Drug Administration has approved a drug specifically designed to treat postpartum depression in mothers, a first for the body.
The FDA has announced in a press release On Tuesday, he approved an intravenous infusion of brexanolone, a drug called Zulresso. Patients would receive continuous IV infusion for 60 hours. The press release says clinical tests, involving more than 200 women, showed that brexanolone worked within hours to help treat postpartum depression, affects 1 new mother out of 9.
Postpartum depression is much more severe and more durable than the "baby blues" that many new mothers live about a week after giving birth. Symptoms of postpartum depression may include sadness, loss of interest, difficulties in bonding with the baby, and even suicidal thoughts.
"Postpartum depression is a serious illness that, when it is serious, can be life threatening. Women may have the idea of hurting themselves or their child. Postpartum depression can also interfere with mother-child relationships, "said Dr. Tiffany Farchione, Acting Director of the Division of Psychiatric Products, Center for Drug Evaluation and Research, FDA. . "This approval marks the first time that a drug is specifically approved to treat postpartum depression, thus offering a significant new treatment option."
Zulresso will be provided only through a Risk Assessment and Mitigation Strategy (REMS) program requiring that a health care provider administer the drug in an institution. accredited health Farchione said the REMS program was needed "because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during the course of administration".
Until now, the only treatment options for people with postpartum depression included counseling or speech therapy, as well as anti-depressants not specifically approved by the FDA to help new mothers with postpartum depression , according to the National Institute of Mental Health.
The 60-hour treatment duration may make it difficult for some new mothers to participate – after all, this involves sedation and patients must be accompanied when interacting with their children during the infusion, the statement said. This is in addition to the cost of treatment, which CNN said will probably $ 20,000 to $ 35,000 per treatment, according to Sage Therapeutics, the biopharmaceutical company that created the treatment. Mothers without extra home support and low-income mothers are often particularly inclined postpartum depression.
Sage Therapeutics also advised patients to talk to their doctor about badfeeding, as the medication would pbad into bad milk.
The treatment is should be available from June After the US Drug Enforcement Administration has scheduled the drug, which will occur within approximately 90 days.
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