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Thread: The FDA Just Approved the First Drug for Postpartum Depression (Zulresso)

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    Default The FDA Just Approved the First Drug for Postpartum Depression (Zulresso)

    Amy Gunia
    March 20, 2019

    The Food and Drug Administration approved the first drug specifically for the treatment of postpartum depression Tuesday.
    The drug, which is administered via an intravenous drip, reportedly works within 48 hours, providing near immediate relief to women experiencing symptoms, according to the New York Times.
    Postpartum depression has historically been treated with counseling or general antidepressants, which can take weeks to kick in or may not work at all.

    Keep reading: http://time.com/5554661/food-drug-ad...3a%22USA%22%7d
    Last edited by Islander; 04-14-19 at 06:31 AM.
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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    One reason for the high cost is that the drug must be infused over a period of 60 hours in the hospital, so hospital costs are added to the $20-$35,000 cost of the dose. Of course, it's supposed to be effective for several weeks...
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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    Pretty hard for a brand-new mother to spend that many hours in a hospital.

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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    Good point Patty. I guess she would have the baby with her?

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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    Could you nurse a baby while getting an intravenous drip? Or soothe a fussy baby? This is a 60-hour continuous infusion, during which time the patient is in the medical center. Update: the last quote from the FDA below says patients must be accompanied during interactions with their child(ren).

    Also, Green Med Info reports that the drug's maker, Sage Therapeutics, "sponsored all the drug's pre-approval clinical trials."

    The FDA's press announcement says:" The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors." https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633919.htm

    I suspect the way they worded the part about "emergent suicidal thoughts and behaviors" is a weaselly way out of actually calling them an adverse reaction. Also, isn't that part of what it's supposed to be treating? How does this make any sense?

    Also according to the FDA, "While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information."
    Last edited by Pattypans; 03-23-19 at 12:31 PM. Reason: 1. To add information 2. Fix paragraph spacing

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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    That last ¶ upsets me a bit. What about the parent-child relationship is so urgent that it must be sealed off in a black-box warning? Doesn't that make you wonder?

    And yes, an antidepressant that activates suicidal ideation? Say what?

    And it's also concerning that Sage Therapeutics was the fox guarding this henhouse. I'm so glad I'm well beyond child-bearing age!
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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    Islander, the I almost used the fox-hen house analogy myself! I figured the warning about supervision for interaction with children must be due to the 'loss of consciousness' 'side' effect, but your comment made me connect it with the 'suicidal ideation or thoughts' warning too.

    Somehow it seems odd to me, this new apparent trend of infusing anti-depressants. First (first I've heard of, anyway) ketamine, now this. Of course, they're working on a pill form of this one, but why would that have any different 'side' effects? They're just looking for easier administration of the drug.

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    Default Re: The FDA Just Approved the First Drug for Postpartum Depression

    Here's a more exhaustive treatment of the risks/benefits of this new drug:
    Is The $34,000 Postpartum Depression Drug Injection Safe and Effective?
    Sayer Ji, Founder
    Friday, March 22nd 2019

    http://www.greenmedinfo.com/blog/34000-postpartum-depression-drug-injection-safe-and-effective?utm_source=Daily+Greenmedinfo.com+Email+ List&utm_campaign=4bdd676847-Postpartum&utm_medium=email&utm_term=0_193c8492fb-4bdd676847-86750250&ct=t(Postpartum)&mc_cid=4bdd676847&mc_eid =097055ab13

    The article includes links to other related stories.
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