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Fluoxetine, Paroxetine Associated With Increased Risk of Foetal Heart Anomalies HOBOKEN, NJ -- November 24, 2008 -- Women who took fluoxetine during the first 3 months of pregnancy gave birth to 4 times as many babies with heart problems as women who did not, and the levels were 3 times higher in women taking paroxetine, according to a study published in the November issue of the British Journal of Clinical Pharmacology. Although some of the conditions were serious, others were not severe and resolved themselves without the need for medical intervention. Based on the results, the researchers suggest that women on fluoxetine should be given a foetal echocardiogram in their second trimester to diagnose possible heart anomalies. For the study, the researchers followed the pregnancies of 2,191 women. Of the women, 410 had taken paroxetine during pregnancy, 314 had taken fluoxetine, and 1,467 who did not take either of the drugs made up the controls. “After we excluded genetic and cytogenic anomalies, we found a higher rate of major heart anomalies in the women who had been taking the antidepressants,” says lead author Asher Ornoy, Israeli Teratology Information Service, Jerusalem, Israel. “Further analysis showed a strong association between major heart anomalies and taking fluoxetine in the first trimester. Women who smoked more than 10 cigarettes a day also had more babies with heart anomalies.” Women taking paroxetine or smoking less than 10 cigarettes a day also faced elevated risks, but not to the same extent. When the researchers looked at the outcomes of all of the pregnancies, they found that: · The prevalence of major heart anomalies was 2.8% in the fluoxetine group, 2% in the paroxetine group, and 0.6% in the control group. There was no increase in other major congenital anomalies. · Previous pregnancy terminations were also higher in the fluoxetine and paroxetine groups than the control group (7.8%, 4.8%, and 2.8%). All groups included some terminations because of diagnosed anomalies. · Birth weights were slightly lower in the fluoxetine and paroxetine groups than the control group (3,200; 3,250; and 3,300g). · Women taking fluoxetine and paroxetine were more likely to smoke than women in the control group (20.1%, 20.7%, and 7.5%) and more likely to smoke more than 10 cigarettes a day (12.3%, 14%, and 4.4%). Taking all the factors into account, the authors calculated that the overall risk posed by antidepressant use and cigarette consumption was as follows: · Women who took fluoxetine during pregnancy were 4.47 times more likely to have a baby with a heart anomaly, and women who took paroxetine were 2.66 times more likely. · Those smoking more than 10 cigarettes a day were 5.40 times more likely to have a baby with a heart anomaly, and women smoking less than 10 cigarettes a day were 2.75 times more likely. “It’s estimated that as many as 1 in 7 women suffer from clinical depression during pregnancy, and clinicians need to weigh the individual risks of pregnant women taking, or not taking, drugs like fluoxetine,” said Ornoy. “Many heart anomalies can now be treated, so it is important to bear that in mind when making a decision about whether or not to continue with one of these drugs during pregnancy. The health of the mother and the baby are both important. We hope that this study will provide both doctors and pregnant women on antidepressants with some of the information they need to help them make those difficult decisions.” SOURCE: Wiley-Blackwell E-mail this page to a friend or colleague! To print, use this version