Antidepressants not linked to birth defects: study

[scotty]

Note the bolded area at the bottom. 30 days use during the prior year was considered "using antidepressants". So someone who used paxil for example in January for 30 days and stopped, got pregnant in December and didn't have a birth defect was considered a good antidepressant outcome. This is disgusting

Antidepressants not linked to birth defects: study
Updated Thu. May. 22 2008 12:01 PM ET

CTV.ca News Staff

A pregnant woman who takes an antidepressant for any length of time during her first trimester does not increase her chance of delivering a baby with a birth defect, a new Canadian study shows.

The study, conducted by researchers from the Universite de Montreal and the Centre Hospitalier Universitaire Saint-Justine, was published Thursday in The British Journal of Psychiatry.

The researchers analyzed data from more than 2,300 pregnant women in Quebec. The women had been diagnosed with at least one psychiatric disorder before pregnancy and had taken antidepressants for at least 30 days in the year leading up to pregnancy.

The research team found no increased risk of delivering a baby with birth defects if a mother took antidepressants during the first 30, 60 or 90 days of her pregnancy.

"No statistically significant association was found between antidepressant duration during the first trimester of pregnancy and the risk of major congenital malformations in infants," the study's authors wrote.

"In addition, the class of antidepressant used was not significantly associated with the occurrence of major birth defects."

The authors also found no difference in birth defect rates between women who used antidepressants during the first trimester and women who had not taken antidepressants at all during pregnancy.

The safety of antidepressant use during pregnancy has been a hotly debated topic in the medical community. However, the authors say that their findings support other research on the topic.

The researchers also point out that studies show women with psychiatric disorders who go untreated while pregnant are at a higher risk of developing other health behaviours, such as smoking and alcohol abuse, which could negatively impact the baby.

As well, a pregnant woman who abandons treatment has a higher risk of her symptoms returning, the authors say.

The researchers say their study should help doctors decide if their patients should continue to take antidepressants while pregnant.

They also suggest that scientists could next study if specific antidepressants have an effect on particular birth defects.


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Abstract:

Duration of antidepressant use during pregnancy and risk of major congenital malformations

Élodie Ramos, MSc, Martin St-André, MD, Évelyne Rey, MD, Driss Oraichi, PhD, Anick Bérard, PhD

Background: Antidepressant use during the gestational period is a controversial topic.

Aims: To determine whether duration of antidepressant use during the first trimester increases the risk of major congenital malformations in offspring of women diagnosed with psychiatric disorders.

Method: A case-control study was performed among women who had been pregnant between January 1998 and December 2002. Data were obtained from a Medication and Pregnancy registry, built by linking three databases from the province of Quebec, and a self-administered questionnaire. Women eligible for this study had to be 15-45 years old at the beginning of pregnancy, have at least one diagnosis of psychiatric disorder before pregnancy, have used antidepressants for 30 days in the year prior to pregnancy and have a pregnancy ending with a delivery. Cases were defined as any major congenital malformation diagnosed in the offspring's first year of life. Odds ratios, adjusted for relevant confounders, were estimated using logistic regression.

Results: Among the 2329 women meeting the inclusion criteria, 189 (8.1%) infants were born with a major congenital malformation. Duration of antidepressant use during the first trimester of pregnancy was not associated with an increased risk of major congenital malformations: 1-30 days v. 0 day, adjusted OR=1.23 (95% CI 0.77-1.9; 31-60 days v. 0 day, adjusted OR=1.03 (95% CI 0.63-1.69); 61 days v. 0 day, adjusted OR=0.92 (95% CI 0.50-1.69).

Conclusions: These data do not support an association between duration of antidepressant use during the first trimester of pregnancy and major congenital malformations in the offspring of women with psychiatric disorders. These findings should help clinicians decide whether to continue antidepressant therapy during pregnancy.

[Who am I]

I may be wrong here but it seems to me that many of these questionable studies are coming out of Canada. I would need to look back at some of the ones posted but that's the top of my head memory. Is there a link here, like less questions asked on the strings attached to the research grant money, less bad press in Canada or something. It just seems that the drug companies are putting lots of funding that way for some reason.

[rdjanis]

Drug companies are putting lots of money this way for two reasons; 1. Canada needs the funding for mental health programs and such, and pharma is pleased to both fund and supply, and 2. the law is different here, until recently, lawyers were unable to be retained against pharma without a huge deposit which most don't have. Money wins. Pharma has yet to be publicly challenged, but it's coming. It is the court cases that brought out all the info in the US, and Canadian lawyers realize the cost of taking pharma to court. There is a lawyer that is about to change all that here though... GSK in particular has spread it's wings here enough in the last year to make me feel like vomiting...

[scotty]

I've been looking for the funding for this study, but it's well hidden..in French!

[elisa]

I don't believe in one word in what the research article says. A horrible thought is that most readers would accept it as the truth!! We know better though.

[elisa]

Originally Posted by scotty

I've been looking for the funding for this study, but it's well hidden..in French!

There are some websites that will translate from French into English for free.

[Who am I]

Laurie, did the news item list where the original study was published or any more specific details other than the authors? If I knew where it was published I could try and find the original study via the University.

Edit 1: Don't worry, I've found it, will read it and let you know.

I found it here: The British Journal of Psychiatry (200 192: 344-350. doi: 10.1192/bjp.bp.107.042523
© 2008 The Royal College of Psychiatrists

Edit 2: I have found no mention of the funding arrangements, it lists all the authors credentials and under "Declaration of interest" it says "none". Unfortunately this does not mean that the University of Montreal didn't have non specific research funding from a pharma, as most universities do these days.

[Who am I]

This is an earlier study done by the same people. Note that the study had its comparison to non SSRI antidepressants, NOT to no antidepressants and Paxil still came out looking bad.

This was funded by what could be called benevolent societies, not phama. Although they are saying it is dose related it is still odd how they have changed their minds so soon.

Original Article
First trimester exposure to paroxetine and risk of cardiac malformations in infants: the importance of dosage
Anick Bérard 1 2 *, Élodie Ramos 1 2, Évelyne Rey 2 3, Lucie Blais 1, Martin St.-André 4, Driss Oraichi 2
1Faculty of Pharmacy, University of Montreal, Montreal, Québec, Canada
2CHU Sainte-Justine, Research Center, Montreal, Québec, Canada
3Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Montreal, Montreal, Québec, Canada
4Department of Psychiatry, CHU Sainte-Justine, Montreal, Québec, Canada

email: Anick Bérard (anick.berard@umontreal.ca)

*Correspondence to Anick Bérard, CHU Sainte-Justine, Research Center, 3175, Chemin de la Côte-Ste-Catherine, Montréal, Québec H3T 1C5

Funded by:
Les Fonds de la Recherche en Santé du Québec (FRSQ)
Le Réseau Québécois de Recherche sur l'Usage des Médicaments (RQRUM)
Le Réseau FRSQ for the Wellbeing of Children

Keywords
paroxetine • pregnancy • major congenital malformations • major cardiac malformations • dosage • pregnancy registry


Abstract
BACKGROUND: Conflicting findings with regard to the teratogenic risks of first trimester use of paroxetine have prompted the FDA, Health Canada, and the manufacturer of the drug to issue warnings against its use during pregnancy. Given that untreated depression during pregnancy can lead to deleterious effect on the mother and her unborn fetus, data on the relationship between the dose and the range of malformations is warranted. This study attempts to quantify the association between first trimester exposure to paroxetine and congenital cardiac malformations, adjusting for possible confounders, and to quantify the dose-response relationship between paroxetine use and cardiac defects. METHODS: The Medication and Pregnancy registry was used. This population-based registry was built by linking three administrative databases (RAMQ, Med-Écho, and ISQ), and includes all pregnancies in Quebec between 01/01/1997 and 06/30/2003. Date of entry in the registry is the date of the first day of the last menstrual period. To be eligible for this study, women had to: 1) be 15-45 years of age at entry; 2) be covered by the RAMQ drug plan 12 months before and during pregnancy; 3) be using only one type of antidepressant during the first trimester; and 4) have a live birth. Two nested case-control studies were carried out comparing the prevalence of paroxetine use in the first trimester of pregnancy to the prevalence of other antidepressant exposures during the same time period. Cases were defined as: 1) any major malformations; or 2) any cardiac malformations diagnosed in the first year of life; controls were defined as no major or minor malformations. Multivariate logistic regression techniques were used to analyze data.

RESULTS: Among the 1,403 women meeting inclusion criteria, 101 infants with major congenital malformations were identified; 24 had cardiac malformations. Adjusting for possible confounders, the use of paroxetine (odds ratio [OR] = 1.38, 95% confidence interval [CI] = 0.49-3.92), and the use of other SSRIs (OR = 0.89, 95% CI = 0.28-2.84) during the first trimester of pregnancy did not increase the risk of congenital cardiac malformations compared with the use of non-SSRI antidepressants. When considering the dose, however, a dose-response relationship was observed, thus women exposed to >25 mg/day of paroxetine during the first trimester of pregnancy were at increased risk of having an infant with major congenital malformations (adjusted [adj] OR = 2.23, 95% CI = 1.19, 4.17), or major cardiac malformations (adj OR = 3.07, 95% CI = 1.00, 9.42).

CONCLUSIONS: Gestational exposure to paroxetine is associated with major congenital malformations and major cardiac malformations for only first trimester exposure above 25 mg/day. Birth Defects Res (Part B). © 2006 Wiley-Liss, Inc.



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Received: 26 July 2006; Accepted: 12 October 2006
Digital Object Identifier (DOI)

10.1002/bdrb.20099 About DOI

[scotty]

Very interesting that the time period that the subjects were taken from is the same as the current study. I feel a payoff to someone up there!

[elisa]

Originally Posted by scotty

Very interesting that the time period that the subjects were taken from is the same as the current study. I feel a payoff to someone up there!

I feel exactly the same!