Lullaby

Editorial Note: Another study published this week suggests that the issue of birth defects on antidepressants rather than suicide or homicide may yet end up as the Mark of Cain by which these drugs are remembered. This post appeared on RxISK.org first.

Hush, little baby, don’t say a word,
Mama’s gonna buy you a mockingbird.
If that mockingbird won’t sing,
Mama’s gonna buy you a diamond ring
If that diamond ring turns brass,
Mama’s gonna buy you a looking glass.
If that looking glass falls down,
All the better for the sweet little babies in town.

In The Beginning 

The first report of antidepressants causing birth defects goes back to 1972.

In the 1980s the companies making SSRIs undertook animal studies to look at the behavioral effects of antidepressants on the offspring of animals given the drugs during pregnancy. These were difficult studies to do because the companies at the same time had to avoid generating evidence of major birth defects, when there was good reason to think the drugs might cause birth defects. The studies that were done gave evidence of both developmental delay and birth defects. This evidence never saw the light of day.

Then a strange study appeared from Motherisk in Toronto claiming there were no behavioral problems in children borne to mothers on SSRIs. The methods used were just what you might have used if you didn’t want to find a problem. This was such an unconvincing study it almost came labeled with Smell a Rat.

In the last five years several decently done studies have been published all pointing to problems such as increased rates of Autistic Spectrum Disorder (ASD) or Developmental Delay (DD) in children born to mothers who have been on antidepressants, primarily serotonin reuptake inhibitors through pregnancy. Aside from the Motherisk study, there is no study saying there is no problem.

A New Study and New Concerns

On Monday a new study by Harrington and colleagues was published with the finding that there is a three to four-fold increase in the rates of Autistic Spectrum Disorder and Developmental Delay in children, especially boys born to mothers who have been on antidepressants through pregnancy. This has already had considerable media coverage.

There are further studies with comparable findings in the offing.

Added to all the evidence from animal studies and epidemiology studies that SSRIs double the rate of major birth defects, double the rate of miscarriages, and increase rates of voluntary terminations, this extra evidence really suggests that these drugs should all be pregnancy category D if not category X.

Not only this but it looks as though the SSRIs may redefine what it means to be a teratogen. Other teratogens produce their effects in the first trimester of pregnancy when organs are first being formed. But it looks like antidepressants used in the third trimester can lead to autistic spectrum disorder and developmental delay.

Pregnancy Category D

Pregnancy drug category C which is what most antidepressants currently are means ‘Use with Caution’. Category D means ‘Do Not Use’. Here’s what a Category D warning would look like:

Category D: (See WARNINGS sectionPregnancy Teratogenic Effects: Pregnancy).

SSRIs can potentially cause fetal harm when administered to pregnant women. If LEXAPRO-PRISTIQ-CYMBALTA  is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the SSRI class, LEXAPRO-PRISTIQ-CYMBALTA is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

When these issues have come up before on RxISK we have tried to engage Mumsnet and anyone else who thinks that putting material like this into the public domain is just scare mongering. We should be much more responsible. (See I’m not Pre-Pregnant, I just have a Womb, and linked posts – The Dark is for Mushrooms, not for Women, and Preventing Precaution and Mumsnet). 

A warning like this does indeed look off-putting and scary. There has been almost no response from women.

Why Benzos and not SSRIs?

But the extraordinary thing about it is that this is the warning that’s on benzodiazepines in the USA. Substitute benzodiazepine for SSRI and XANAX for LEXAPRO-PRISTIQ-CYMBALTA and you have the XANAX warning.

Even more amazing is the fact that there is not a fraction of the animal studies or epidemiological data pointing to pregnancy risks on benzodiazepines comparable to the data there is for the antidepressants.

The MHRA is Britain’s FDA equivalent. Asking them about the pregnancy risk of benzodiazepines turns up no evidence in the last 20 years that they are aware of indicating a risk from benzodiazepines. According to MHRA, they have been advising women not to take benzodiazepines from the get-go and the warnings were strengthened when the marketing of SSRIs got into full swing in the 1990s and SSRI companies were doing a great deal to blacken the name of the benzodiazepines.

There is nothing about the UK warnings that looks half as scary as the FDA warning, but FDA provide no link to the evidence base for this warning.

The best explanation for this warning is that its a hang-over from efforts twenty years ago by SSRI companies to elimination benzos and replace them with a group of drugs that cause as many if not more problems. This was a supremely successful marketing campaign to make Valium seem darker and scarier than Prozac. On the street Valium sounds almost as dangerous as Heroin – while within mental health care if forced to take Valium or Prozac for life, nine out of ten staff would take Valium. Prozac – and other SSRIs – are by far the darker drugs.

Meanwhile Back in Denmark

Meanwhile Back in Denmark, as elsewhere, there is a drive to screen all pregnant women for depression and get them on antidepressants.  Women are being bullied and harassed into treatment by unfounded claims that leaving a depression untreated will cause birth defects and developmental delay.

Peter Gotzsche, one of Denmark’s leading epidemiologists, a longtime skeptic about many screening programs,  and more recently someone who has been publicly wondering whether  psychiatry needs to be compulsorily detained because of the risk it poses to people in general (Psychiatry Gone Astray), gave a lecture 6 months ago to Danish doctors on the insanity of screening for depression in pregnancy.

A video of his lecture can be found here.  The Transcript of the screening part is here.  The section on screening is almost at the start.  The horror on the video wonderfully transcends translation and perhaps is all the better because of Peter’s lack of training as a stand-up comedian.

Hush little baby don’t you Cry
Momma’s gonna buy you an SSRI.


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Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. Vera Rabie says:

    How sad. But it makes a lot of sense because autism is a disorder that involves interpersonal emotions and emotional connections to the outside. It is as if the unborn child suffers from an extreme form of the intended effects of such a drug, that being the “dumbing down” of emotional responses, which at that age translates to the capability for attachment to other humans.

  2. Bernard Carroll says:

    This discussion introduces a topic that I call behavioral teratology. Going back at least to the late 1960s, there is a long history of preclinical studies in that area, many of them concerned with effects of psychiatric and neurological drugs on sexual differentiation of fetuses. Credible human studies have been sadly lacking.

    In connection with SSRI use in pregnancy, it is worth recalling that major migrations of neurons occur late in fetal brain development, so we ought not be surprised to find behavioral outcomes like autism linked to third trimester exposure rather than to the better known first trimester exposure for somatic development.

  3. Excellent, greatly needed warning I hope gets much more widely spread and read.

  4. I wonder how Catholic pro-life psychiatrists can ignore the evidence that SSRIs can cause miscarriage, birth defects and voluntary abortions? Surely this goes against everything they stand for?

    In Ireland Psychiatrist Patricia Casey is a patron and co-founder of the Iona Institute, a Catholic anti-abortion think tank. She recently stated that for the ‘clinically’ depressed pregnant woman, antidepressants and/or cognitive therapy are desperately needed to prevent a woman from taking her own life. How does she marry the fact that the Catholic Church are anti-abortion and yet advocate for SSRIs in pregnancy when they cause all of the above?

    Irish psychiatry, despite all the regulatory warnings, also collectively deny that these group of drugs can cause suicide or violence. In 2012 Irishwoman Anna Byrne was Carrying twins (almost full term) when she died by jumping off Howth head. She had been on Paxil/Seroxat which was discontinued early in her pregnancy. She was then put on Sertraline/Zoloft by her GP who described it as “a commonly used antidepressant during pregnancy”. Anna’s dose of sertraline was doubled 6 days before her death by her psychiatrist, John Sheehan. This SSRI did not prevent Anna and her babies deaths; the risks did not outweigh the benefits.

    Did Sertraline in fact cause their deaths and where is the public outcry for these three young lives? The denial by Irish psychiatry of any adverse effects of SSRIs is truly shocking.

  5. http://public.gsk.co.uk/

    This is the GSK UK Public Site for reporting a suspected side-effect.

    It re-directs you to MHRA/yellow card.

    It is orange and it is very, very tiny………………..did you spot it or is it too early in the morning………?

  6. What would Andrew say to my doctor.

    You dropped her 20 mg. off Seroxat, you gave her Diazepam, Lorazepam, Chlordiazepoxide and Propanolol. You gave her Paroxetine liquid and then introduced Fluoxetine.

    Speak to your doctor?

    Lucid speech was long gone. Hallucinations followed.

    This is outrageous says, Andrew.

    *This is not what we intended. I don’t quite know what we did intend, but, your doctor is guilty not us.*

    What doctors do is completely their affair.

    Is this correct?

    Peter Gotzche thinks we might have permanent brain damage.

    If trying to stay awake, trying to psyche oneself out of the noise in the head, and trying to get the mo-jo back is damage, then, it is possible he is quite right.

    Do all these drugs equate to long term damage? On, off, on, off, on, off.
    Makes me giddy thinking about how I innocently swallowed so much of it.

    And swallowed not a word from anyone. Just take this. I did.

    Don’t we look back and see what utter fools we were.
    Too late now. The damage is done.

    I know what Henry went through and continues to go through.
    Thank goodness, I did not take the Prozac offered or anything else offered…………..

    STOP IT….I thought….just STOP IT….I don’t want anymore………….

    http://www.telegraph.co.uk/news/features/10789916/Lives-left-in-ruin-by-rising-tide-of-depression-drugs.html

  7. What would Andrew say to my doctor… Part Two

    http://www.forbes.com/sites/erikakelton/2014/04/28/glaxosmithklines-spin-doctoring-doesnt-cure-corruption-problems/

    “Andrew should be prescribed a full dose of reality – with unlimited refills”

    Seems Forbes joined in the conversation…….

  8. Peter Spaeth says:

    They won’t be content until every single one of us is on an antidepressant (and a statin), will they? My God. Thank you Dr. Healy for being — to quote the wonderful Auden poem — “a voice to undo the folded lie.”

  9. What would Andrew say to my doctor….Part Three

    I, unsuccessfully, was a litigant with Hugh James Solicitors who took Glaxosmithkline to settlement regarding Paroxetine.

    When Mark Harvey threw in the towel, having decided that our case was 50/50, on advice, he almost threw away our chances of successful litigation.

    I am now with another law firm who I am hopeful will successfully bring a court action against Glaxosmithkline.

    Just wondering how Hugh James were handling their unsuccessful bid, and loss of thousands, to represent us, it seems, Hugh James, are still citing our Seroxat case on their website.

    Why?

    Is Mark Harvey so desperate not to leave any stains on Hugh James re his diabolical failure to represent us, or, is there something, that I am missing here?

    I will repeat, I am not represented by Hugh James Solicitors.

    My medical records are now with another lawyer. I signed a form to allow my medical records to be transferred to Secure Law.

    These two solicitors, are based in Cardiff.

    Who exactly is representing me with Paroxetine as a harmful product?

    http://www.hughjames.com/service/personal-injury-illness/harmful-product-compensation/seroxat/

  10. More jiggery-pokery on the Seroxat Disinformation Leaflet.

    http://public.gsk.co.uk/products/seroxat.html

    Chinese (Simplified) translation of “have shot your bolt”
    UK informal
    › to have already achieved all that you have the power, ability or strength to do and to be unable to do more
    已竭尽全力
    He started off the game well but seemed to have shot his bolt by half-time.
    比赛开始时他表现不错,但半场时似乎M已经筋疲力尽了。

    “When you point a finger at the moon to indicate the moon, instead of looking at the moon,the stupid ones look at your finger.”
    ― Mao Tse-tung

    Or

    D. Cameron might or might not choose his friends wisely and might or might not listen to the Chinese and might or might not put business before ethics.

    D. Cameron is not, yet, a wise man, yet, he has, yet, to learn a little about naivety and we have seen more failed friendships with D. Cameron than, perhaps, any other prime minister.

    D. Cameron has taken away knighthoods from Banking Crooks and Sexual Deviants.

    But, to look at GSK closely, is a challenge for him and for us…….

  11. http://www.alltrials.net/2014/new-alltrials-video-make-clinical-trials-count/

    Hello, GlaxoSmithKline, nice to see your face in Ben’s video and his ethics are awesome, wonderful and quite magnificent.

    But, once, again, GlaxoSmithKline are playing the flute for the loot and got Ben waaarapped around their little finger………

  12. Maybe the recent “increase in autism” that has been in the headlines recently is because many of these children were born to moms on SSRI’s. Or then again, maybe there really is no increase at all…

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