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FDA Approves First Oral Treatment for Postpartum Depression

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Re: FDA Approves First Oral Treatment for Postpartum Depression

#261

Post by loeg »

aaronbrethorst wrote: post #168

I don't normally like to talk about matters this personal in a forum like this—especially given that I use my real name as my username here, but if it ends up helping one person then I think it'll be worth it. My son was born a little over 9 months ago. He's healthy, delightful, and utterly normal—and yet I, his father, still ended up with postpartum depression. I think it's underreported and under-appreciated that f…

I don't have anything to add, just -- another new dad here -- wanted to say thanks for sharing and I'm glad it's working for you.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#262

Post by loeg »

cnees wrote: post #238

It would be amazing if this were safe to use while breastfeeding, but further research shows they haven't tested for it's presence in breastmilk yet.

> further research shows they haven't tested for it's presence in breastmilk yet.

What? This claim is easily falsifiable. Section 8.2, Lactation:

> Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk.

> A steady-state milk study was conducted in 14 healthy lactating women treated with daily oral administration of 30 mg of ZURZUVAE for 5 days. At steady state (Day 5), the calculated maximum relative infant dose for ZURZUVAE was < 1%. The daily infant dose was low (approximately 0.0013 mg/kg/day), reflecting a mean relative infant dose of 0.357% compared to the maternal dose. Concentrations of ZURZUVAE in breastmilk were below the level of quantification limit (BQL) by 4-6 days after the last dose.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#263

Post by maxbond »

linuxftw wrote: post #254
maxbond wrote: post #62

Earlier quoted context omitted.

We are having regular threads on HN about how the FDA is not approving drugs fast enough and someone in our community is dying and cannot access the experimental drug that may have saved them. Example: https://news.ycombinator.com/item?id=36827438

I'm all for people having access to whatever they want. What I'm not for is the FDA fully approving something without a sufficient amount of testing.

If your concern is that it's present in breast milk, it seems pretty easy to address - feed the baby formula while the mother is taking the medication, and about a week after (I am not a doctor, this is not medical advice).

Presumably, that's why prescribing information says:

> 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.

The benefits are presumably being weighed because they don't anticipate the mother breastfeeding the infant while she is on the medication.

Have you considered that perhaps they didn't test it on infants, not because they're a corrupt rubber stamp, but because there is no ethical way to do so? There is no possible benefit to the infant, but there is potential risk; that would violate the principle, "first, do no harm."

Why put children at risk when the problem is avoidable in the first place by not breastfeeding?

Re: FDA Approves First Oral Treatment for Postpartum Depression

#264

Post by loeg »

haldujai wrote: post #136
astrange wrote: post #92

Earlier quoted context omitted.

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…

I don't follow or care about the EMA or HC because I don't live in Europe or Canada. Nevertheless, the FDA sucks.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#265

Post by habinero »

nemo44x wrote: post #249
habinero wrote: post #205

Earlier quoted context omitted.

The suicide warning for antidepressants is misleading. They don't cause it, but what happens is antidepressants start giving you more energy and more ability to function before it starts helping with mood. So if you're already suicidal, you can get the ability to act on it before you start getting relief from ideation.

That’s darkly humorous. That a persons depression is the only thing stopping them from killing themselves. And to get to a better state they have to cross the stage where they are still depressed but have acquired a “can do” attitude. End of day I think scrambling the brain is almost always the wrong choice. That these things are so heavily prescribed and marketed - what does that say?

It says nothing. They don't "scramble" your brain, or artificially make you happy, or any of the other ignorant things people have said. You are exactly the same person on AD as you are off of them.

This is like pretending that anyone who gets antibiotics is weak and if you just exercise, you can beat infected wounds.

Before antibiotics, people just died from wounds. Before AD, people spent their whole lives trapped by things we can do something about now.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#266

Post by habinero »

esel2k wrote: post #246
AndrewThrowaway wrote: post #245

Earlier quoted context omitted.

I think I share exactly the same experience and the very same thing helped greatly for me. I was just not diagnosed any postpartum depression but rather good old GAD. After the birth of a son life changed 180 - no free time, no personal time etc etc. All you can expect. Less sleep, a lot of unknowns and anxieties. Again - expected. Less time with wife. Feelings of down, depression. Some anger problems. But it all loo…

How are things after? The few PCP or psychiatrist friends told me that these meds have a huge addiction potential. Could you be without it again?

Most psych meds are not addictive, in the sense that they don't give you a high to be abused.

You have to titrate off a lot of them, but that's true of a lot of drugs and that's also not addiction.

Benzos _are_ potentially addictive, but if used correctly can help a lot. They also aren't generally prescribed as first-line treatments.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#267

Post by habinero »

loeg wrote: post #260
NoZebra120vClip wrote: post #223

Earlier quoted context omitted.

Dramatically increased chances of suicidal ideations and actions, when 25 years and under. So, the opposite of "effective".

Uh, if you're reading off table 1 at section 5.3, that's across all chronically-administered SSRIs -- not this drug in particular. Zurzuvae was evaluated in much smaller clinical trials of 347 women 18-44 and as far as I can tell, did not have any incidences of discontinuance due to suicidal ideation.

The suicide warning for AD is misleading. They don't _cause_ suicidal thoughts, but they can give you energy and the ability to function before they start lifting mood.

So if you're already suicidal, you can regain the ability to act on it before you get relief

Re: FDA Approves First Oral Treatment for Postpartum Depression

#268

Post by gillytech »

maxbond wrote: post #219
dna_polymerase wrote: post #199

Earlier quoted context omitted.

You used the r-word. You come here with claims that go against the status quo and provide zero evidence to support your claims. Just admit it, you don't like gay people. No need for this idiotic 'AIDS is fake' charade.

This is too far a leap, that haven't said anything overtly homophobic. It's likely they aren't homophobic, who knows. When we make leaps like this we risk the conversation devolving into something where the germane criticisms are lost. It's a lot easier to critique their position and rhetoric than to interrogate the content of their soul, and they will always have the home court advantage there. I'm not the rhetoric…

You got it exactly right. Simply stating a fact is not an attack on anyone. In any scientific inquiry one needs to consider all the similarities and differences in the data. Most notably, if HIV is spread through sexual contact, why was it most prevalent in gay men of a particular lifestyle in a particular place? If it were straight white Amish people that it was attacking, I would say the same thing.

Not that it matters, but my sister is gay and I am going to be in her wedding this October. I have a much more nuanced understanding of homosexuality as my twin falls into this category.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#269

Post by akerl_ »

pazimzadeh wrote: post #195
tptacek wrote: post #25

Earlier quoted context omitted.

For 99.9999% of humanity's history, penicillin was "never needed". Antidepressant usage is universal throughout Europe. It makes more sense to treat postpartum depression, not less, because it's so likely to have a straightforward chemical cause. That's why there is an oral treatment specifically targeting it.

> For 99.9999% of humanity's history, penicillin was "never needed" *pure penicillin https://en.wikipedia.org/wiki/Tocosh and they are not the only ones to do something like this. I wonder why the American natives got so much sicker from European diseases than the Europeans did from the local native disease. It's almost like cities are petri dishes.

https://www.youtube.com/watch?v=JEYh5WACqEk is a good watch here, if you're curious why Europeans didn't catch reciprocal plagues when traveling to the Americas.

Spoiler: it's what the adjacent comment said, the Americas didn't have the factors for plagues.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#270

Post by nobody9999 »

Madmallard wrote: post #145
nobody9999 wrote: post #35

Earlier quoted context omitted.

>Likely far more of the former than the latter per medicine's track record in the last couple decades I'd say that "medicine" has advanced quite a bit over the last few decades. Five year survival rates for cancers are up 40%[0] since 1975. AIDS treatments, when administered properly, extend the lives of infected persons by more than 500%[1] over those who don't receive such treatment. Advances in orthopaedic (especi…

I'd argue you're far more forgiving and optimistic than what's realistically happening with respect to ""medicine" is more than just Big Pharma, insurance companies and healthcare conglomerates" My experience with a semi-edge-of-medicine chronic condition has been absolutely atrocious nearly across the board and even with the absolute experts. And there's multifactorial reasons for it.

>My experience with a semi-edge-of-medicine chronic condition has been absolutely atrocious nearly across the board and even with the absolute experts. And there's multifactorial reasons for it.

Your anecdote (as vague as it is) isn't very helpful in making any sort of point. I'd add that your interaction with the healthcare system wherever you may be is irrelevant in the aggregate WRT medical advances that have provably and measurably made folks healthier and live longer.

My goal here isn't to persuade you of anything. Rather, it's to point up that your attitude and (claimed) experience is, at best, orthogonal to my comment.

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