FDA approves first pill for postpartum depression.
FDA approves first pill for postpartum depression.
FDA Approves First Oral Drug for Postpartum Depression
Aug. 7, 2023 – In a major breakthrough, the FDA has given its approval for the first oral drug to treat postpartum depression, a condition that affects approximately one in seven mothers in the United States. The pill, known as zuranolone, or Zurzuvae as its brand name, has been developed by drugmaker Biogen and offers new hope for women struggling with postpartum depression.
Postpartum depression is a serious mental health condition that often goes undiagnosed and untreated. Many mothers hesitate to reveal their symptoms to their family or doctors, fearing being judged on their parenting abilities. Sadly, postpartum depression can even lead to thoughts of self-harm or harm towards their child. As Dr. Tiffany R. Farchione, the director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research, explains, postpartum depression “can also impact the maternal-infant bond and have consequences for the child’s physical and emotional development” as women grapple with extreme and sometimes life-threatening emotions.
Up until now, the only approved therapy for postpartum depression required long infusions in hospital settings and came with a hefty price tag of $34,000. The approval of Zurzuvae offers a more accessible and affordable option for women suffering from this debilitating condition.
The recommended dosage for Zurzuvae is 50 milligrams once daily for 14 days, preferably in the evening with a fatty meal. The drug acts on specific receptors in the brain that regulate mood, arousal, behavior, and cognition. Its effectiveness has been supported by a study published in the American Journal of Psychiatry in 2023, which demonstrated significantly improved depressive symptoms as early as day 3 of treatment. These improvements were sustained throughout the course of treatment and follow-up.
One of the significant advantages Zurzuvae offers is its ability to also alleviate symptoms of anxiety in patients. The study showed improved anxiety symptoms in those who received the active drug compared to those who received a placebo. This dual-action effect is an encouraging finding for mothers who often experience both postpartum depression and anxiety concurrently.
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The trial for Zurzuvae identified a few common side effects, such as sleepiness, drowsiness, and headaches. However, there were no reports of weight gain, sexual dysfunction, withdrawal symptoms, or increased suicidal behavior. It’s important to note that Zurzuvae can affect a user’s ability to drive or perform other potentially hazardous activities. Therefore, the packaging will include a boxed warning, recommending users to avoid driving or operating heavy machinery for at least 12 hours after taking the pill.
The FDA’s approval of Zurzuvae marks a significant milestone in the treatment of postpartum depression. By providing a convenient, oral alternative to costly and time-consuming IV therapies, Zurzuvae ensures more mothers have access to effective treatment options. This breakthrough will undoubtedly bring new hope and improve the lives of countless women and their families affected by postpartum depression.
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