Postpartum Depression Pill Zurzuvae Gets Approval From Food and Drug Administration

The Food and Drug Administration has significantly advanced women's healthcare by approving the first oral treatment for postpartum depression.

The drug, known as zuranolone and branded as Zurzuvae by Sage Therapeutics and Biogen, comes in the form of a once-a-day pill, CBS News noted.

Zuranolone is intended explicitly for adults experiencing postpartum depression, a form of major depression that can manifest after childbirth or during the later stages of pregnancy.

This condition affects approximately 15% of women in the weeks or months following childbirth.

The approval of this oral medication is a groundbreaking development in the mental health field.

Dr. Tiffany Farchione, the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research director, emphasized the significance of having an accessible oral treatment for these women.

Before this approval, the only FDA-approved option for postpartum depression treatment was Sage Therapeutics' brexanolone, marketed as Zulresso, which required intravenous infusion.

With zuranolone, a new and promising avenue is available to tackle postpartum depression effectively.

Sage Therapeutics and Biogen believe that zuranolone functions similarly to a steroid, binding to GABA receptors in the brain to reset neurotransmitters that may be disrupted in patients grappling with depression.

What Is Postpartum Depression?

Postpartum depression is a severe and possibly life-threatening condition that affects women after childbirth, with symptoms ranging from sadness and guilt to thoughts of self-harm or harming the child.

The condition can also disrupt the maternal-infant bond, impacting the child's physical and emotional development.

Recognizing the gravity of this mental health issue, Farchione highlighted the importance of effective treatment options, per the US Food and Drug Administration.

Approving the oral medication zuranolone, branded as Zurzuvae, offers a beneficial option for women grappling with these extreme and sometimes life-threatening emotions.

The drug's availability as a pill enhances accessibility and may provide much-needed relief to those experiencing postpartum depression.

Symptoms of postpartum depression are akin to other forms of depression and can include feelings of worthlessness, loss of interest in favorite activities, cognitive impairment, and decreased ability to experience pleasure.

Common Side Effects of Zurzuvae

Considering its approval for the treatment of postpartum depression, the FDA has added a boxed warning to the labeling of zuranolone to alert patients to potential safety concerns, according to CNN.

The warning emphasizes that the drug may impact a person's ability to drive and perform other hazardous activities.

Patients may experience impairment without being aware of the extent of it. To minimize the risk of harm, the FDA advises patients to avoid driving or operating heavy machinery for at least 12 hours after taking the medication.

Like any medication, zuranolone may have side effects such as drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection.

Additionally, the FDA cautions that using this drug may lead to suicidal thoughts and behavior, necessitating careful monitoring of patients during treatment.

Furthermore, zuranolone may pose a risk of fetal harm.

As a precaution, women are advised to use effective contraception while taking the medication for one week after its use.

This article is owned by Latin Post.

Written by: Bert Hoover

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