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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

#121

Post by teslabox »

ksenzee wrote: post #78
_9pxx wrote: post #36

Earlier quoted context omitted.

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?

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…

There is a currently approved treatment. It’s basically an allopregnanolone supplement, given as an IV infusion over 60 hours, for $34,000.

There are much cheaper treatments for PPD, but nothing that would ever pay for the approval process.

https://twitter.com/jamesknochel/status/1688023798447316992?...

Re: FDA Approves First Oral Treatment for Postpartum Depression

#122

Post by [deleted] »

xivzgrev wrote: post #91
MarkMarine wrote: post #65

Earlier quoted context omitted.

I’m in this right now, my wife has symptoms that are in a word, scary. The rug pull of hormones that happens after birth, they can turn a stable, well adjusted, incredibly good mom into someone who is afraid to hold their own baby. We’re in 3 groups, we have a private therapist for this, and if it’s anything like last time there will be another light switch at 4-6 weeks where she is suddenly back to normal. This pill…

Absolutely. My wife also has it and talk therapy was not enough. She’s now on anti depressants so I’m thrilled theres a new drug specifically for post partum.

[deleted]

Re: FDA Approves First Oral Treatment for Postpartum Depression

#123

Post by whateverman23 »

roody15 wrote: post #30

[flagged]

> Is this really a pharmaceutical issue or a societal structure and support issue.

Any if it is? We surely can't solve every, or even most societal issue that causes it.

You can continue to support improvements to the societal issues of the world while still supporting pharmaceutical interventions for those who need it right now.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#124

Post by duncan-donuts »

ekianjo wrote: post #101
ksenzee wrote: post #63

Earlier quoted context omitted.

If you are not a researcher, or a physician, or some other expert, and if you have not given birth yourself, please don’t throw out this kind of ill-considered opinion. Post-partum depression (and anxiety for that matter) is more severe than just the effects of sleep deprivation and lack of support. Anything we can do to treat it, even partially, is worth doing.

[flagged]

My wife couldn’t sleep after giving birth to our second kid and it spiraled quickly into full blown psychosis. My wife still can’t sleep right nearly 10 years later.

There’s no shame in taking antidepressants. Some of us have brains that don’t work quite right and we should have more options than “cope” or self terminate.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#125

Post by NickM »

Palomides wrote: post #97
xmddmx wrote: post #31

Earlier quoted context omitted.

On the 17 item HAM-D here are the typical score ranges [1] Not depressed: 0–7 Mild (subthreshold): 8–13 Moderate (mild): 14–18 Severe (moderate): 19–22 Very severe (severe): >23 So, a 4 point difference vs placebo is what I would consider a "clinically significant" improvment, e.g. about the difference between mild vs. moderate, or moderate to severe. https://en.wikipedia.org/wiki/Hamilton_Rating_Scale_for_Depr...

based on a look at the actual contents of the HAM-D, four points isn't exactly an impressive improvement for a $11,000 treatment a four point improvement could be a person stops fidgeting during the interview daily reminder that psychology is the worst science in terms of the replication crisis

If you think that’s bad, go look up some SSRI meta analyses. The average HAM-D improvement vs placebo is only about 2 points.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#126

Post by pertymcpert »

roody15 wrote: post #30

[flagged]

My wife suffered from PPD, you can take your opinion here and shove it where the sun don't shine. In the midst of her anguish, no amount of having family support could help her. I wish this would have been available.

Typical HN upvoted bullshit from people who are trying to be contrarian to every fucking good thing that's done..

Re: FDA Approves First Oral Treatment for Postpartum Depression

#127

Post by NickM »

ellisv wrote: post #9
duskwuff wrote: post #7

Earlier quoted context omitted.

> Why would you mention the number of items on the scale, but not mention the number of points the drug gained? Is it that professionals normally refer to it as the "17-item Hamilton depression rating scale"? Correct. "17-item Hamilton depression rating scale" (or HAMD-17) is the precise name of the scale; "17-item" is required to distinguish it from other variations with different numbers of questions. The precise i…

> The precise improvement in scoring is undoubtedly present in the clinical trial paper, but isn't relevant to a FDA press release about their approval of the drug. Exactly. If it isn’t harmful, it doesn’t have to be very helpful — the effect can be small and significant.

If it isn’t harmful

That’s a big “if” though.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#128

Post by haldujai »

_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?

> Of all the things that seem wrong with solving this with a pill

Is this based on any experience (clinical or research) in postpartum depression or some philosophical objection?

In case you were unaware of what severe postpartum depression can look like:

Severely ill patients often report suicidal ideation and behavior, typically demonstrate obvious impairment of functioning, and often manifest poor judgement that places the patient and others (including children) at risk for imminent harm. In addition, patients are more likely to develop complications such as psychotic and catatonic features and have a history of severe or recurrent episodes. Patients with severe major depression should be referred to a psychiatrist for management and often require hospitalization.

Source: UpToDate

> Is the FDA immune from suits if this results in a generation of damaged kids?

Sued for what? It's clearly stated in the drug monograph.

Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk (see Data). There are no data on the effects of zuranolone on a breastfed infant and limited data on the effects on milk production.

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.

https://documents.sage-biogen.com/us/zurzuvae/pi.pdf

> We should compare the kids"?

All patients enrolled in the trial were asked to stop breastfeeding. It is unethical to perform the study you are suggesting and even if it were no IRB would approve per regulations.

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...

Re: FDA Approves First Oral Treatment for Postpartum Depression

#130

Post by refurb »

j45 wrote: post #119
arriu wrote: post #68

Earlier quoted context omitted.

As a Canadian, I can confirm 12 months is not enough let alone 6 weeks… I am deeply saddened at the thought of mothers having to go back after so little time

18 months doesn’t seem like much either

Government should pay me 100% of wages for 18 years!
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