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FDA Approves First Oral Treatment for Postpartum Depression

fda.gov

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Re: FDA Approves First Oral Treatment for Postpartum Depression

#131

Post by haldujai »

_9pxx wrote: post #102
ksenzee wrote: post #78

Earlier quoted context omitted.

Because there is no currently approved treatment for postpartum depression, what they’re comparing here is the danger of untreated PPD against the danger of either discontinuing breastfeeding or having the newborn ingest a small amount of this medication. Untreated PPD is no joke. Not only does the mother’s suffering matter in itself, it has serious documented effects on the baby. And there is nothing wrong or neglig…

> And there is nothing wrong or negligent about “solving this with a pill.” It needs solving. It is a serious issue. Your points are well made, though this isn't really what I said. For what it's worth, while I'm worried the decision was made on what essentially amounts to an assumption, the option for using formula exists for parents worried about the drug making it into breast milk. So it seems there's at least one…

It's already labelled for breastmilk excretion.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#132

Post by refurb »

linuxftw wrote: post #17

[flagged]

This is such a lazy comment and the fact that you didn't copy paste the paragraph that followed makes me think you have some agenda to push.

"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition."

Re: FDA Approves First Oral Treatment for Postpartum Depression

#133

Post by refurb »

_9pxx wrote: post #36
linuxftw wrote: post #17

[flagged]

Of all the things that seem wrong with solving this with a pill, I think this is the single most grotesquely negligent element of this approval. Is the FDA immune from suits if this results in a generation of damaged kids? Was it so hard to say "oh..... It ends up in breast milk. We should compare the kids"? Even if it defers the approval by some years?

No of course the FDA won't get sued because it literally lays out the risks. That's their job.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#135

Post by pertymcpert »

RcouF1uZ4gsC wrote: post #24

I wonder how much of post-party depression is caused by isolation. In the past, new mothers were surrounded by a whole village of women who would help care for the woman and the baby. Many times now, women are isolated with maybe the father present. And even then there are pressures to get back to work. This isn’t to discount or minimize postpartum depression, but if we as a society set up people for failure which re…

Good question I guess. It's not fixed by being surrounded by a village. A village helps, but if you've never experienced PPD before then let me elaborate. PPD at its worst can bring psychosis. Read that again, psychosis. This is not something you can hug to make better.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#136

Post by haldujai »

astrange wrote: post #92
gillytech wrote: post #40

Earlier quoted context omitted.

Yes the FDA is immune from all the harm id does the the population.

The FDA mostly harms the population by not approving drugs fast enough.

For drugs approved between 2011 and 2015 the FDA approval time was a median 303 days, faster than the EMA at 369 days.[1]

For drugs approved between 2000 and 2010 (for all 3 agencies, the FDA gets more applications) the FDA approval time was a median of 268 days, faster than the EMA at 356 days and Health Canada at 366 days.[2]

Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?

[1] https://www.nejm.org/doi/10.1056/NEJMc1700103

[2] https://www.nejm.org/doi/full/10.1056/NEJMsa1200223

Re: FDA Approves First Oral Treatment for Postpartum Depression

#137

Post by rysertio »

01100011 wrote: post #3

https://en.wikipedia.org/wiki/Zuranolone "An orally active inhibitory pregnane neurosteroid, zuranolone acts as a positive allosteric modulator of the GABAA receptor." Interesting. I was expecting another SSRI or something similar.

Benzos directly hammer on GABA receptors while pregnanes use G coupled progesterone receptors to transduct signals to the GABA system.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#138

Post by ildon »

roody15 wrote: post #30

[flagged]

> Postpartum Depression holistic patient view versus commercial pharmaceutical treatment.The shear emotional, physical and life changes involved in having a baby is in many ways similar to PTSD. In just a few weeks your body has been physically exhausted, your mentally and emotionally drained and now you are physical/spiritually/ and emotionally bond to a new human life who is 100 percent dependent on you for its survival and well being.Now imagine this leads to a period of depression in the patient. Is this really a pharmaceutical issue or a societal structure and support issue. Perhaps even more than just that.It is depressing to me to see things like this get pushed out … just take this pill and it will help move you up a few points on our 17 point scale and cope.Instead of wow, let’s really look at what’s happening with the birthing process on how we prepare mothers and support them emotionally, physically and maybe even spiritually.Nope just take this drug and in 6 weeks you will be back to work and we can get that new kid in daycare :/#rantover

Re: FDA Approves First Oral Treatment for Postpartum Depression

#139

Post by ildon »

roody15 wrote: post #30

[flagged]

> now you are physical/spiritually/ and emotionally bond to a new human life who is 100 percent dependent on you for its survival and well being.

Not to mention that this is the best case scenario. Unfortunately deliveries of non-alive babies carry the same postpartum problems, without the joy of life

Re: FDA Approves First Oral Treatment for Postpartum Depression

#140

Post by waynesonfire »

roody15 wrote: post #30

[flagged]

absolutely true. i am not at all surprised we're suffering from low birth rates. we should have done what japan is doing very long ago. the amount of support new parents receive in modern society is a joke

https://www.japantimes.co.jp/news/2023/03/31/national/child-...

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