Part IV: "Please don't forget about me": Antidepressants and birth defects

Patient safety is our highest concern


By —— Bio and Archives June 10, 2017

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Last February, Dr. Bérard and her colleagues published an updated analysis of the Quebec Pregnancy Cohort data. Between 1998 and 2009, the rate of antidepressant use during pregnancy for the study population doubled, from 2.1% to 4.3%. During that same period, the rate of major congenital malformations increased by more than 50%, and the rate of maternal depression went up slightly as well.

In addition, the study once again confirmed the link between paroxetine and heart defects, finding that the drug was associated with a nearly 50% rise in the rate of major cardiac malformations. The study also showed that venlafaxine, the active ingredient in Effexor (the drug that Christiane took during her pregnancies) more than doubled the incidence of major respiratory defects (which two of Christiane and Amery’s children suffered from).

Part I: “Please don’t forget about me”: Antidepressants and birth defects
Part II: A gigantic uncontrolled experiment
Part III: I was Absolutely Distraught
Part IV: Patient safety is our highest concern

Are the drug companies grooming the next generation of customers in the womb?

These figures are almost certainly underestimates of the true numbers of pregnancies affected, since they omit pregnancies which end in spontaneous abortion, and also those that end in therapeutic abortion after detection of fetal abnormalities via ultrasound. Antidepressants during pregnancy have been linked to increases in both spontaneous abortions and therapeutic abortions.

Is anyone surprised? These drugs inhibit the uptake of serotonin, an evolutionarily ancient signaling molecule that predates the origin of animal life itself. Serotonin acts as a growth factor during embryogenesis, directing the development of the heart, the lungs, the brain, and probably every other organ in the body. Is it any wonder monkeying with serotonin levels during embryonic development can cause problems?

And what about more subtle effects that may take years to manifest themselves? We don’t know for certain, but studies on rodent models give us a hint. When researchers gave Prozac to mice during the developmental stage corresponding to the third trimester of pregnancy in humans, they found that the mice as adults were reluctant to explore new environments, preferring to hide in the dark rather than walk in the clear light of day. The mice lost interest in eating, and were slow to bestir themselves to avoid a painful electric shock or to escape when imprisoned in a cylinder full of water. In short, the mice appeared fearful and despondent—precisely those conditions for which antidepressants are prescribed to humans.

Are the drug companies grooming the next generation of customers in the womb?

Why do doctors prescribe these drugs to pregnant women—or anyone, for that matter? Because they are safe and effective remedies for depression, of course. Or are they? Last January BMC Open published the most comprehensive meta-analysis yet of SSRI’s for major depression, reviewing 131 studies involving 27,422 patients. And what did the reviewers find? They found that SSRI’s were correlated with an increase of less than two points on the 52-point Hamilton Rating Scale for Depression, an improvement far too paltry to be detected in a face-to face assessment of global functioning by a trained clinician. They also found that every one of the studies was at a high risk for bias, that the bias most likely favored the drug over placebo, and that SSRI’s caused a 37% increase in the rate of serious adverse events. In addition, only six of the 131 studies included data on suicides and only eight on suicidality—odd, given that suicide prevention routinely is used as justification for dispensing these drugs.

Last March, a settlement was reached on behalf of Meah Bartram and 50 other Canadian children born with congenital defects whose mothers used Paxil during pregnancy. GlaxoSmithKline agreed to pay out $6.2 million, but admitted no wrongdoing. In a statement, the company declared “Patient safety is our highest concern.”

Peter Breggin, a psychiatrist of nearly 50 years’ experience and the author of Psychiatric Drug Withdrawal, offered this assessment: “Women don’t need antidepressants during pregnancy. They need a therapeutic approach to bringing the family together to support them. Pregnancy is a very vulnerable time. You don’t want to take a neurotoxin—which antidepressants are—that’s going to impair your ability to think and feel, and that’s going to make it much harder to relate to your offspring.I believe that a fully informed mother would not want to do that.

“We’ve lost the concept of how important a mother is to a child. You know how important the first months are, you know these drugs can even go into the mother’s milk, you’ve got multiple problems with these drugs around the whole issue of mother-child relationships and child development.

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“The advice I would give women: Avoid this. Don’t start the drugs. If you have started them, find somebody who will help you come off them safely and effectively.If you need emotional help, get drug-free counseling and build a strong support system for yourself.”

Dr. Healy, who served as an expert witness in the Bartram case, had a different take on matters: “The key issue here is not for me to say that women should or shouldn’t have these drugs. It’s the kind of support that I can offer. These drugs come with a withdrawal profile, and it can be actually quite hard to get off of them.

“You know, a little bit depends on the dose, and a little depends on the agent that she’s on. It may be the case that the agent she’s on may be less likely to cause a problem, so I can offer her a bit of reassurance that maybe she’s not on the most problematic one. Further, it may be the dose. If she is on a high dose, her options might include trying to reduce the dose rather than trying to halt completely.

“I try to put the possible ramifications on the table for her and to have her work out what she is most comfortable with. Some women do not want to take any risk at all, and they will will actually like to halt. It really is not up that me to decide that you should halt or not halt. The issue is offering the support to the woman to take whatever risk she wants to take either way, whether it’s the risk of staying on the drugs or the risk of coming off them. My job is to support her and get the best outcome for her.”

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And what about the Schultzes, whose lives have been turned upside-down by the pharmaceutical industry? “The last nine years have been an absolute Hell,” Amery says, although he and his family at last seem to be approaching a sort of stability. Amery himself has been through a couple of career changes. When he and Christiane got married, he was working as a carpenter, building greenhouses, but he had to give up that line of work after after a botched surgery to try to repair a back injury he sustained in a car accident. He reinvented himself as a certified financial planner, but abandoned that line of work as well, after the death of his son Matthew. “Talking to people about death on a daily basis just wasn’t fun anymore,” he observes drily. He reinvented himself again, going back to university and training as a social worker. Today he runs a shelter for the homeless. Their four surviving sons are all homeschooled, along with their daughter from Christiane’s first marriage.

“Finding a new normal—we’re still in that process,” he observes. “In our lives today we get by as well as we can. We’re doing all right.”

When I ask him what advice he has for people who might be considering taking psychiatric drugs, he doesn’t hesitate for a second. “Don’t take them,” he replies. “Not every little thing in life has to be treated with a pharmaceutical.”

When I ask him what the alternative is, again he doesn’t hesitate. “Connection,” he tells me. “Where I have success in the work I do, it’s just making that human connection [with my clients], letting them know they matter.”

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List of Sources

 

  • Bérard, A. et al. 2017. Antidepressant use during pregnancy and the risk of major clinical
  • malformations in a cohort of depressed pregnant women: an updated analysis of the Quebec Pregnancy Cohort.
  • Azmitia, E.C. 2001. Modern views on an ancient chemical: Serotonin effects on cell proliferation, maturation, and apoptosis. Brain Research Bulletin 56:413-424.
  • Sadler, T.W. 2011. Selective serotonin reuptake inhibitors (SSRI’s) and birth defects: Potential mechanisms for the observed associations. Reproductive Toxicology 32:484-489.
  • Andrews, P.W. et al. 2012. Primum non nocere: an evolutionary analysis of whether antidepressants do more harm than good. Frontiers in Psychology 3:1-19.
  • Ansorge, M. et al. 2004. Early-life blockade of the 5-HT transporter alters emotional behavior in adult mice. Science 306:879-881.
  • Ansorge, M. et al. 2008 Inhibition of serotonin but not norepinephrine transport during development produces delayed, persistent perturbations of emotional behaviors in mice. Journal of Neuroscience 28:199-207
  • Popa, D. et al. 2008. Lasting syndrome of depression produced by reduction in serotonin uptake during postnatal development: Evidence from sleep, stress, and behavior. Journal of Neuroscience 28:3546-3554.
  • Malm, H. et al. 2016. Gestational exposure to selective serotonin reuptake inhibitors and offspring psychiatric disorders: A national register-based study. Journal of the American Academy of Child and Adolescent Psychiatry 55:359-366.
  • Breggin, P.R. 2012. Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients, and Their Families. Springer Publishing Company.
  • Canadian Press 2017. B.C. firm reaches $6.2M Paxil settlement in class-action lawsuit against GlaxoSmithKline.
  • Jakobsen, J.C. et al. 2017. Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis.
  • Leucht, S. et al. 2013. What does the HAMD mean? Journal of Affective Disorders 148:243-248.
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  • Moncrieff, J. and I. Kirsch 2015. Empirically derived data cast doubts on the clinical significance of anti-depressant-placebo differences. Contemporary Clinical Trials 43:60-62.

  • Patrick D Hahn -- Bio and Archives |

    Patrick D Hahn is an Affiliate Professor of Biology at Loyola University Maryland and a free-lance writer. His writing has also appeared in Biology-Online, Loyola Magazine,Popular Archaeology, Natural News,Canada Free Press, and the Baltimore Sun.

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