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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

#201

Post by habinero »

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.

Because the old world had plagues (diseases that spread fast and kill) and the new world did not. Plagues and pandemics are zoonotic, and the new world just didn't have any domesticable animals except llamas.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#202

Post by psychphysic »

astrange wrote: post #108
techie128 wrote: post #105

This is a uniquely American problem and an American solution. American healthcare and society fails new mothers. Others have done a great job of pointing out the physical and emotional distress a new mother goes through. However, I'd like to point out the social aspect. New mothers in America are not supported by paid family leave. Vast majority of women are required to go back to work in about 2 weeks after birth. F…

Postpartum depression does not only occur in the US, and is more common in other countries.

He has a point about shitty US support around parental leave though.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#203

Post by haldujai »

NoZebra120vClip wrote: post #180
haldujai wrote: post #174

Earlier quoted context omitted.

What black box warning are you talking about? The only one I see for Zurzuvae is: "IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES"[1] [1] https://documents.sage-biogen.com/us/zurzuvae/pi.pdf

My bad - not a black box in this case. Just a regular box. Sorry for the confusion.

Black box (obsolete) and regular box are the same thing, they're simply called boxed warnings. In case you think this is semantics, boxed warnings are a determination by the FDA of a risk of adverse reaction so serious in proportion to the benefit of the drug it must be considered when assessing risks and benefits.

The warning you are referring to is a regular warning which is used when there some evidence of a causal association but a causal relationship has not been definitively identified.

In this specific instance it is based on an association of increased suicidality in a study looking at all antidepressants for all depressive indications and specifically in patients below the age of 25, not specific to this drug or drug class. This warning is accordingly present on all antidepressants.

I won't go into the knowledge base behind this warning, its magnitude and variation between drugs but it is readily available online.

Suffice it to say medical experts do not view the risk serious enough to merit a boxed warning and should the FDA have wanted to absolve themselves of blame as. you suggest it would be boxed.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#204

Post by psychphysic »

cbhl wrote: post #13
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…

Apparently the brand name `Zurzuvae` in the first paragraph links to a PDF of the full prescribing info from the FDA. Pages 17-18 list the exact changes in HAM-D score over the first 15 days on the drug and the following 30 days after. Both Zurzuvae and Placebo showed improvement in HAM-D over the 15 day period, but Zurzuvae showed a greater improvement. (From 28.6 to 13, vs 28.8 to 17.2, for a difference of -4.0 poi…

> Both Zurzuvae and Placebo showed improvement in HAM-D over the 15 day period

Which is why everyone wanted to see it compared to Alprazolam/Xanax or Zopiclone

Re: FDA Approves First Oral Treatment for Postpartum Depression

#205

Post by habinero »

psychphysic wrote: post #200
nemo44x wrote: post #15

> Use of Zurzuvae may cause suicidal thoughts and behavior. Zurzuvae may cause fetal harm. Might be better off just smoking a joint.

I dug into the FDA docs and relevant studies over the post few months. As far as I can tell that warning might be just boilerplate for antidepressants these days. Similarly for foetal harm it's on animal studies and they advice effective contraception for 1 week after last dose while they collect data.

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.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#206

Post by psychphysic »

xyzzy_plugh wrote: post #142

Since every top level comment here is a borderline tire fire, let me be the first to say: This is great news. We need better treatments for PPD, which is real and very serious that can cause long term lasting effects in serious cases without treatment, and can sadly even be fatal. Quality of life has risen steeply over the past several decades but mothers still walk an unpaved road. It's deeply worrying the lack of s…

> We need better treatments for PPD

It was compared to placebo.

People are rightly highly suspicious of Big Pharma.

I like the idea of a novel class but I won't pay attention to this new, expensive drug until it proves significant efficacy over older cheaper drugs (like Alprazolam and Zolpidem/Zopiclone).

Technically it's a Z-drug (like Zolpidem/Ambien) which are non-benzodiazapine positive allosteric modulators of GABA_A However, since it's a neurosteroid most will probably not think of it as such. (It's name does begin with Z though... And end in -one like a steroid).[Note below]

Anyways, it's licensed for 2 weeks only, side effects are drowsiness, sleepiness and cognitive impairment. You mustn't drive within 12 hours of a dose.

It's best effects are where the depression is associated with insomnia and anxiety.

It was compared to placebo not Alprazolam (Xanax) which has some antidepressant activity. That's just how you seek market Auth when nothing else is licensed. That's just smart.

But you have a GABA agonist you must only use for the short term with primary anxiolytic and hypnotic effects. That will be widely used because otherwise you need off license script and will likely put even more people on the path to SSRI.

[0] this is a reckless insightless cognitive impairment think Roseanne Bar racist tweet.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#209

Post by flangola7 »

zpeti wrote: post #165
mtlmtlmtlmtl wrote: post #150

Earlier quoted context omitted.

Thank you. I'll never understand why there's such a dominance of luddite thinking, bad takes and conspiracy theories on HN, when it comes to the topic of mental health. Especially when it comes to drug treatments. Psychiatry no doubt has a lot of problems with it. But it's also the only game in town for a huge amount of people. What's the alternative? Prayer circles? Ayahuasca tourist traps? Cannabis? Homeopathy? Giv…

It’s very easy to explain. By going straight to medication you are treating the symptom not the cause. And you don’t even know if it works. SSRIs don’t work for many people and we only found out 2-3 years ago. Opioids were prescribed to half of America for back pain. That gives scope for healthy scepticisms at least. Just because you might have some anecdotal evidence of some chemicals working, doesn’t mean it works…

While I agree there are often additional deeper causes, picking up a prescription will begin faster than waiting for capitalism to be done away with.

Re: FDA Approves First Oral Treatment for Postpartum Depression

#210

Post by astrange »

throwaway2037 wrote: post #179
astrange wrote: post #113

Earlier quoted context omitted.

PPD is more common in developing countries where this isn't true.

I tried to Google about this, but found nothing. Can you share a study? I am interested to learn more.

Wikipedia has relatively recent sources, 2017.

https://www.sciencedirect.com/science/article/abs/pii/S01650...

> Additionally, prevalence was significantly higher in women from low and middle income countries compared to women from high income countries (OR 1.8, 95% CI 1.4–2.2). The overall pooled prevalence was 11.9% of women during the perinatal period (95% CI 11.4–12.5).

https://en.wikipedia.org/wiki/Postpartum_depression#Epidemio...

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