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First drug specifically for postpartum depression is approved

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Shep
Posted (edited)

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 by Shep
fixed typo

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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

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direstraits

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

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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. 

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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... 

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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.

 

 

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