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FDA APPROVES FIRST PILL FOR POST-PARTUM DEPRESSION

The pill, which would be taken daily for two weeks, significantly decreased postpartum depression among new mothers in a recent clinical trial.


Depresion posparto
FDA APPROVES FIRST PILL FOR POST-PARTUM DEPRESSION

Photo by EKATERINA BOLOVTSOVA


The pill, which would be taken daily for two weeks, significantly decreased postpartum depression among new mothers in a recent clinical trial.


This news is very encouraging for millions of women who suffer from this condition, which affects 1 in 7 mothers after giving birth. The most important thing postpartum is to recognize Postpartum Depression (PPD) if you have it and seek help.

Postpartum Depression (PPD) vs. Baby Blues

When I had my first baby, I thought I was a bad mother. I didn't feel that magical connection that many say they feel with the birth of a child. Obviously, these thoughts were something that only I knew, as I didn't dare to share them with anyone for fear of being judged. It was as if my child was an emotional burden, and all I wanted was to pass that responsibility on to someone else.

Furthermore, the baby's room, which I had decorated with so much excitement for his arrival, caused me almost unbearable distress. It reached a point where I couldn't even use that space to feed or put my baby to sleep.

At that moment, I didn't understand what was happening to me, so I decided to do some research. I found out that it was the "Baby Blues." What I didn't know at that time is that this condition is normal and usually lasts up to two weeks after childbirth. However, if these feelings of sadness or distress persist beyond that period, they can develop into what we know as Postpartum Depression (PPD).

"Postpartum Depression is a condition that, when severe, can endanger the lives of the women who suffer from it. These mothers may have thoughts of harming themselves or their children. Postpartum depression can also interfere with the mother-infant bond," says Tiffany Farchione, M.D., Acting Director of the Division of Psychiatry Products at the FDA's Center for Drug Evaluation and Research.

Now, there's a pill to combat PPD

The U.S. Food and Drug Administration (FDA) has approved the intravenous injection of Zulresso for the treatment of Postpartum Depression (PPD) in adult women.

This is the first medication approved specifically for PPD by the FDA. Due to concerns about serious risks, such as excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified healthcare centers where providers can carefully monitor patients. This approval marks the first time a drug has been specifically approved to treat Postpartum Depression, providing a significant new treatment option, according to Dr. Farchione.

How does the Zulresso program work?

Zulresso will be available only through a restricted program called the 'Zulresso REMS Program' at a certified healthcare center. The REMS program requires that patients enroll in the program before receiving the medication. Zulresso is administered as a continuous intravenous infusion for a total of 60 hours (2.5 days).

Due to the risk of serious harm due to sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and must have continuous pulse oximetry monitoring (which monitors oxygen levels in the blood).

While receiving the infusion, patients must be accompanied during interactions with their children throughout the full 60 hours of the. These steps are outlined as warnings in the medication's prescription information. Patients should not drive, operate machinery, or engage in other hazardous activities until the drowsiness caused by the treatment has completely dissipated.

What did the studies reveal about the effectiveness of Zulresso?

The effectiveness of Zulresso was demonstrated in two clinical studies in which participants received a continuous intravenous infusion of Zulresso or a placebo for 60 hours and were then followed for four weeks. One study included patients with severe PPD, and the other included patients with moderate PPD. The primary measure in both placebo-controlled studies was the average change from baseline in depressive symptoms measured by a depression rating scale. In both placebo-controlled studies, Zulresso demonstrated superiority over placebo in improving depressive symptoms at the end of the first infusion. Improvement in depression was also observed at the end of the 30-day follow-up period. The most common adverse reactions reported by patients treated with Zulresso in clinical trials include drowsiness, dry mouth, loss of consciousness, and hot flashes. Healthcare providers should consider changing the therapeutic regimen, including discontinuing Zulresso, in patients whose PPD worsens or who experience emergent suicidal thoughts and behaviors.

We hope that with further research, obtaining an over-the-counter medication to help with this condition will be possible. The important thing is that if you believe you are experiencing Postpartum Depression, don't stay silent and seek help as soon as possible.

If you are experiencing PPD and need immediate help, contact the SAMHSA National Helpline. The SAMHSA National Helpline, at 1-800-662-4357 (also known as the Treatment Referral Service) or TTY: 1-800-487-4889, is a confidential, free service available 24 hours a day, 365 days a year, in English and Spanish, for individuals and families facing mental health or substance use disorders. This service connects you with local treatment centers, support groups, and community organizations. Also, visit the online treatment locator.

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use, as well as medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation-emitting products, and regulating tobacco products in the United States. Source: FDA.gov.


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