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 first appeared on RxISK.org and can be viewed here.
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.
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.
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 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.
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, 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.