First drug specifically for postpartum depression is approved

[Shep]

Washington Post - First drug specifically for postpartum depression is approved

 

March 19 

 

The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression.

 

Some key facts taken from the article: 

 

• The newly approved drug, called brexanolone, will be marketed under the name Zulresso. Its manufacturer, Sage Therapeutics in Cambridge, Mass., said a course of treatment would probably cost $20,000 to $35,000.
• The drug, she said, is administered intravenously for 60 continuous hours. The approval requires that it be administered under strict safety conditions because of concerns it can cause “excessive sedation and sudden loss of consciousness.”
• The drug will be available to patients only through a restricted distribution program at certified facilities — such as doctors’ offices or clinics — where health-care providers can carefully monitor the patient. It will carry a “boxed warning,” which is the strongest warning required by the FDA.
• The FDA-approved label says data from a study in which a dozen women who were breast-feeding received the drug showed that the medication is transferred to breast milk in nursing mothers. However, the amount that is passed to the infant is low, and available data “do not suggest a significant risk of adverse reactions to breastfed infants from exposure to Zulresso.”
• The main component of drug is allopregnanolone, “a breakdown product” of the hormone progesterone that affects the GABA neurotransmitters, which have a role in mood regulation, Meltzer-Brody said. She added that the exact mechanism of action is unknown.
• The FDA’s advisory committee recommended approval of brexanolone in early November, but the agency delayed the green light to evaluate concerns about the small number of women who lost consciousness while receiving the drug. 
• Given the way the drug will be administered, Glezer said she expects it to be used mainly on the most severe cases, especially women whose postpartum depression requires hospitalization.

 

The US currently does not have laws protecting women in the labor market that provides paid time off for maternity leave. But I don't see that listed in the article as a reason that so many women are suffering from anxiety and depression after giving birth. 

 

I haven't had time to do any research regarding the fact that this drug targets GABA receptors, but drugging a new mother to the point of losing consciousness doesn't inspire any confidence that these researchers have anyone's best interest in mind except the stock holders for this overpriced neurotoxin. 

 

Also, since the drug is targeting women who "require hospitalization" (i.e. psychiatric prisons), I have to wonder about informed consent regarding adverse effects, as well as if it will be done involuntarily. Since ECT targeting women is on the rise, there needs to be a conversation about the potential violation of civil rights that accompany anything called "treatment" in a psychiatric prison. 

 

 

Edited March 20, 2019 by Shep
fixed typo

[apace41]

I have not done any research on this topic, Shep, but on the face of it this is shocking and so troubling I can't really find the words.

 

1 hour ago, Shep said:

She added that the exact mechanism of action is unknown.

 

At least they are being honest with this one.  How that gets it approved is beyond me?  Shouldn't we know how things work when they affect the brain? 

 

I agree that this is going to be used as a means of forced drugging, without consent, of some of the most vulnerable in society.

 

Just tragic.

 

Best,

 

Andy

[direstraits]

omg...this is disgusting...where does it end?😲😞😩

[Shep]

21 hours ago, apace41 said:

At least they are being honest with this one.  How that gets it approved is beyond me?  Shouldn't we know how things work when they affect the brain? 

 

I agree that this is going to be used as a means of forced drugging, without consent, of some of the most vulnerable in society.

 

Ah, I think you answered your own question. Psychiatry has always been about social control, not medicine. 

 

17 hours ago, direstraits said:

omg...this is disgusting...where does it end?😲😞😩

 

Hopefully, one day, psychiatry itself will be ended.

 

Thanks for commiserating with me, Andy and DS. 

[withhopeinmyheart]

Ew, I'm disgusted and shocked. Now they poison troubled moms who need real care and a safe environment (meaning NO psych hospitals!) 

 

My God, can they stop pathologizing any and everything that is human and natural? While I would never negate the suffering that postpartum depression can be, the answer to that can never be drugs... 

[Shep]

A voice of reason - Dr. Kelly Brogan has written a great article over on MiA about this travesty.

 

Postpartum Depression: Is Brexanolone the Answer?

 

By Dr. Kelly Brogan

March 24, 2019

 

I was going to bullet point a few key findings, but the article was so good, I would have to bullet point EVERYTHING in it. But here is some information specific to this new "wonder" drug (I added the bold for emphasis). Note that the investors (stockholders) are given information that makes it less likely they will invest in it, while I doubt new mothers are given any warning at all. 

 

 

Quote

 

One of the newest drugs rushed to market for the treatment of postpartum depression is called brexanolone. In September of 2017, brexanolone failed its clinical trial⁴ as a treatment for super-refractory status epilepticus, but just two months later, the drug was being touted as a cure for postpartum depression, gaining fast-track status from the FDA.⁵ That’s despite the fact that the more trials were conducted, and the larger the sample of women they tested became, the less statistical significance the drug’s effect showed… compared to an ordinary placebo.⁶ As one publication that tracks biotech for investors explained, “The data contain a few blemishes that, while unlikely to derail the drug, raise questions about the extent to which it will improve the lives of people with PPD and where its peak sales will top out.” If stockholders have concerns, women who are potential candidates for the drug should have even greater concerns.

 

In fact, according to the FDA briefing document: “Although the difference from placebo at Day 30 was not significant, it appears that the effect of brexanolone was maintained while the placebo group improved.” Yes, you read that correctly… placebo outperformed the sedative impact of an IV infusion after 60 hours, without side effects that include loss of consciousness.

 

 

Another piece of the article that stood out is this:
 

Quote

 

Women today are mothering without the wisdom of generations before them, without the support of their female family, friends, and community. In fact, they are spending large swaths of time alone with their infants. It is likely, however, that a number of survivalist danger signals would be set off if a woman found herself alone with a baby. In fact, it’s likely that we are now setting historical precedent as a woman has likely never been left alone with a baby — without surrounding tribeswomen — in the history of humanity.

 

 

[gn11]

On 3/20/2019 at 7:33 AM, Shep said:

Washington Post - First drug specifically for postpartum depression is approved

 

March 19 

 

The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression.

 

Some key facts taken from the article: 

 

• The newly approved drug, called brexanolone, will be marketed under the name Zulresso. Its manufacturer, Sage Therapeutics in Cambridge, Mass., said a course of treatment would probably cost $20,000 to $35,000.
• The drug, she said, is administered intravenously for 60 continuous hours. The approval requires that it be administered under strict safety conditions because of concerns it can cause “excessive sedation and sudden loss of consciousness.”
• The drug will be available to patients only through a restricted distribution program at certified facilities — such as doctors’ offices or clinics — where health-care providers can carefully monitor the patient. It will carry a “boxed warning,” which is the strongest warning required by the FDA.
• The FDA-approved label says data from a study in which a dozen women who were breast-feeding received the drug showed that the medication is transferred to breast milk in nursing mothers. However, the amount that is passed to the infant is low, and available data “do not suggest a significant risk of adverse reactions to breastfed infants from exposure to Zulresso.”
• The main component of drug is allopregnanolone, “a breakdown product” of the hormone progesterone that affects the GABA neurotransmitters, which have a role in mood regulation, Meltzer-Brody said. She added that the exact mechanism of action is unknown.
• The FDA’s advisory committee recommended approval of brexanolone in early November, but the agency delayed the green light to evaluate concerns about the small number of women who lost consciousness while receiving the drug. 
• Given the way the drug will be administered, Glezer said she expects it to be used mainly on the most severe cases, especially women whose postpartum depression requires hospitalization.

 

The US currently does not have laws protecting women in the labor market that provides paid time off for maternity leave. But I don't see that listed in the article as a reason that so many women are suffering from anxiety and depression after giving birth. 

 

I haven't had time to do any research regarding the fact that this drug targets GABA receptors, but drugging a new mother to the point of losing consciousness doesn't inspire any confidence that these researchers have anyone's best interest in mind except the stock holders for this overpriced neurotoxin. 

 

Also, since the drug is targeting women who "require hospitalization" (i.e. psychiatric prisons), I have to wonder about informed consent regarding adverse effects, as well as if it will be done involuntarily. Since ECT targeting women is on the rise, there needs to be a conversation about the potential violation of civil rights that accompany anything called "treatment" in a psychiatric prison. 

 

I just read recently that the FDA approved a drug for ppd. Is this the sames as 2019 or a new one? Has anyone been following this here.? 

 

[Shep]

18 hours ago, gn11 said:

I just read recently that the FDA approved a drug for ppd. Is this the sames as 2019 or a new one? Has anyone been following this here.? 

 

The drug mentioned in the opening post in this thread is brexanolone, administered intravenously. The latest drug is a pill, zuranolone. Here is more on this latest drug:

 

First Pill for Postpartum Depression Approved

 

Both drugs have commonalities, as listed in that article:

 

Quote

Zuranolone is a “first cousin” of brexanolone, says Meltzer-Brody, who was principal investigator of brexanolone’s clinical trials. Both drugs mimic allopregnanolone, a naturally occurring neurosteroid that protects the brains of pregnant people and their fetuses from stress during pregnancy. The drugs target the brain’s GABA receptors—part of a major signaling pathway that is responsible for stress and mood regulation—to compensate for reduced levels of allopregnanolone in people with postpartum depression. In contrast with traditional SSRIs, zuranolone and brexanolone provide fast and sustained relief after a single course of treatment. Zuranolone has been modified so it can be ingested in a more convenient oral form, however.

 

Since both drugs target GABA, they seem to have more in common with benzos and alcohol than SSRIs. 

 

Incredibly cruel to do this to women and especially to babies. 

 

[gn11]

16 hours ago, Shep said:

 

The drug mentioned in the opening post in this thread is brexanolone, administered intravenously. The latest drug is a pill, zuranolone. Here is more on this latest drug:

 

First Pill for Postpartum Depression Approved

 

Both drugs have commonalities, as listed in that article:

 

 

Since both drugs target GABA, they seem to have more in common with benzos and alcohol than SSRIs. 

 

Incredibly cruel to do this to women and especially to babies. 

 

Thanks for sharing. It is beyond cruel. How far is our corrupt capitalist system  (based on marketing untruths) willing to go. I am going to read on this issue more carefully so that I can write a letter to the NYT and other papers about this. I read a posting on a women's group in FB and people were celebrating this drug!?!  I wrote a scathing response.

[littlebird]

On 3/20/2019 at 4:33 AM, Shep said:

the medication is transferred to breast milk in nursing mothers. However, the amount that is passed to the infant is low, and available data “do not suggest a significant risk of adverse reactions to breastfed infants from exposure to Zulresso.”

Terrifying! We gotta wait and see how this goes I guess. Can't help but think about Thalidomide, probably won't be that dramatic but we can't know how this affects growing babies (let alone their mothers). 

[Rosetta]

What happens to the women who have been on ADs prior to the administration of this new drug?
 

As many of you may know, the very night I had my baby, an OB, whom I had never met before, changed my AD from Celexa 60 mg to Zoloft at 10 mg.  Her reason for the change was that the baby might not breastfeed if I continued taking Celexa.  I trusted her, of course.  The response by my GP to the withdrawal effects was to raise the dose of Zoloft — doubling it.  (And it went on from there up to 150 mg.  The thought that WD might be an issue never entered the mind of any doctor I saw.)

 

Chances are the OB’s intentions were good.  Chances are the GP’s intentions were good.  They were just employees of an HMO.  They had no reason for personal gain to practice medicine with this sort of gross negligence.  

Ultimately, I ended up with akathisia.

I am very lucky that I survived.  My baby has been very lucky that I survived.
 

My privately hired midwife warned me about many things that might happen when I gave birth in hospital.  She apparently had no clue of the real danger I faced, and this lack of knowledge continues to exist in the population of “medical professionals.”  The OB who was there for my wellness check ups all throughout my pregnancy never mentioned the possibility that I might be told to change Celexa to another drug.  I did not research this issue before or after my baby was born.  I thought I needed ADs.  Since, I have never been able to find any follow up study that confirmed that Celexa affects the ability to feed nursing babies.  It appears that the issue has been dropped.
 

This blind trust by both med profs and patients!  
 

It will be extremely unlikely that a woman suffering from PPD will NOT have been on a much less expensive drug for weeks or months prior to the administration of these two new drugs, intravenous and pill forms.  Has there been any consideration given to the effect of the new drug on the nervous system of the AD addicted?  Surely, the AD will be suspended during a 60 hour treatment, and if the hype is believed, she should be cured after this course of intravenous drugs. Bye, bye AD!  We all know that careful tapering will not be discussed.

 

Someday we will all read about how many more people died (or had their lives ruined) than were saved from post-partum depression.  Researchers do not know how the new PPD drug works!  We have heard that before.  Opium “worked,” too.

 

🧚🏻‍♀️Rosetta