Network 12-1.pdf - Canadian Women's Health Network

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Services & Policy Research, and a Steering Committee member of Women and Health Protection. She and colleagues are aware of the conflicting information about the safety and benefits of taking selective serotonin reuptake inhibitor (SSRI/SNRI) class anti-depressants (such as Prozac, Paxil and Effexor) during pregnancy. What is known is that anti-depressants are being prescribed to pregnant women ‘off-label,’ meaning prescribed for a use for which they were not approved. Mintzes explains that “Anti-depressants are unapproved for use in pregnancy in Canada, or actually in any other country.” While it is illegal for drug companies to promote their products for ‘off-label’ use, doctors can prescribe any drug for any use once it is on the market. There is a generally recognized need for caution when using medications during pregnancy that has come out of two disasters – Thalidomide and Diethylsilbestrol (DES), drugs that had devastating effects on babies born to women who took them while pregnant. In the case of Thalidomide, some babies had severe birth defects. DES caused higher rates of cancer and reproductive problems in adult women who were exposed while their mothers were pregnant with them. DES sons also have higher rates of abnormalities of the reproductive organs. Additionally, women who took DES while pregnant have higher rates of breast cancer. These disasters, Mintzes notes, brought attention to the possibility of unpredictable and long-term harm from drug use in pregnancy. With that in mind, and with the conflicting advice women were receiving about using SSRIs while pregnant, Mintzes and colleagues decided to wade through the studies that had been done to see if there was in fact evidence of benefit to taking these drugs for women and their babies. Any time a medicine is used, there is a need to weigh the potential benefit against the potential harm. This is why medicines have to be tested systematically before they’re approved for use. With ‘off-label’ use – as is the case with antidepressants in pregnancy - the company marketing the drug has not had to show scientific evidence to the government of a specific benefit for this use. That evidence may or may not exist. Since all medicines can cause harm as well as benefit, unless there is rigorous scientific evidence that benefit is likely to outweigh harm, a medicine should not be taken. Mintzes worked with Patricia Fortin, a research consultant at UBC’s drug assessment group Therapeutics Initiative, Jon Jureidini, an Associate Professor at the University of Adelaide’s Department of Psychiatry and UBC Pediatrics professor Tim Oberlander. Funded mainly by Health Canada’s Bureau of Women’s Health and Gender Analysis, they carried out a systematic search for all studies comparing women with depression who did or did not take antidepressants during pregnancy, and evaluated the study results. Their conclusion? Even after searching for all published and unpublished studies – worldwide – and despite the many claims made in favour of antidepressant use, they failed to find any scientific evidence that either pregnant women or their babies benefit from use of SSRI/ SNRI antidepressants. Mintzes’ team found eight studies of women who were pregnant and diagnosed with depression. In all cases, the studies compared the outcomes for mothers and babies of those taking antidepressants and those who had no treatment of any kind. There were no studies, Mintzes notes, comparing pregnant women who took SSRI/SNRIs with those who were treated in other ways, such as cognitive-behavioural therapy or regular exercise. The size and quality of the eight studies varied, as did the degree of depression of the women who participated. All were observational, meaning that although there was a control group, women who chose to take antidepressants were compared with others who did not. Interpreting the results was complicated by differences between the women who took antidepressants and those who did not. For example, some had a longer history of depression or more severe depression. Five of the eight studies were also quite small, with weaker research methods, and in those cases, Mintzes notes it was hard to say why 12 FALL/.WINTER 2009/2010 NETWORK
there were so many poor birth outcomes. Was it the exposure to the drug, or was it because of differences between the women who were and were not taking antidepressants? Were issues like poverty, known to be a factor in depression and birth outcome, taken into account? The three larger – and more scientifically solid - studies they reviewed followed large populations of women, including one that included all women in British Columbia who gave birth between 1998 and 2001. However at the end of the review, none of the studies – whether large or small – showed any degree of benefit from antidepressant use. When there is no scientific evidence of benefit, says Mintzes, there is reason to be concerned when use of a treatment is widespread. In looking at studies in non-pregnant women as secondary evidence of whether or not there might be a benefit to pregnant women, Mintzes finds there isn’t evidence that SSRIs work better than non-drug treatment, like psychotherapy for most forms of depression, and she is concerned that the benefits of SSRIs in adults – pregnant or not – have been shown to be exaggerated. There is also the consideration that depression is often incorrectly diagnosed. A systematic review of studies found that family doctors incorrectly diagnose a person with depression 15 times for every 10 correct diagnoses. As for the impact on babies, the eight studies found that children born to women taking SSRIs had 4.2% (1 in 24) greater incidence of respiratory distress than among women with depression without SSRI exposure, and a 0.6% higher rate of cardiac malformation (1 in 159), again as compared with women not taking antidepressants. This is a signal that babies exposed to antidepressants seem to be doing worse in some ways than those not exposed. It adds to a larger body of literature on harmful effects of antidepressants in pregnancy. “The question is, why is this treatment being very heavily recommended for use in pregnancy given the lack of scientific evidence of benefit?” asks Mintzes. “There is no rationale for the recommended use of SSRIs in pregnancy.” Jane Shulman is the Director of Knowledge Exchange at the Canadian Women’s Health Network. Watch the webinar at www.cwhn.ca CWHN is developing an in-depth information sheet about SSRIs and pregnancy available for download soon on our website. Some SSRI stats: • Andepressants are among the most frequently prescribed class of drugs for women of childbearing age in Canada. • In 2003 – 2004, 11-14% of women in Brish Columbia between the ages of 25 and 39 received at least one prescripon for an andepressant. • In 2008, 80% of women in Canada who spoke about depression to their doctors were given a prescripon, usually for an SSRI. • In 1998, just over of 2% of pregnant women in BC used an andepressant. By 2001, the rate of use had grown to 5%. CANADIAN WOMEN’S HEALTH NETWORK FALL/.WINTER 2009/2010 13
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