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• W4233358888 abstract "We thank Jansson and colleagues for their interest in our study1Broussard C.S. Rasmussen S.A. Reefhuis J. et al.Maternal treatment with opioid analgesics and risk for birth defects.Am J Obstet Gynecol. 2011; 204: 314.e1-314.e11Abstract Full Text Full Text PDF PubMed Scopus (255) Google Scholar and welcome the opportunity to address their concerns. Recall bias is often raised as a criticism of the case-control study design. However, previous studies have found that this is unlikely to account for associations between maternal exposures and birth defects among infants in studies such as ours.2Khoury M.J. James L.M. Erickson J.D. On the use of affected controls to address recall bias in case-control studies of birth defects.Teratology. 1994; 49: 273-281Crossref PubMed Scopus (69) Google Scholar Moreover, if a recall bias exists in our study, it might be in the opposite direction because the average time between delivery and maternal interview was 11 months for case mothers and 9 months for control mothers.Covariates for our regression models were chosen based on the strength of their relationship with all National Birth Defects Prevention Study birth defects in univariate analyses. Periconceptional alcohol consumption was not a confounder using this approach and thus was not included in our regression models.Additionally, given the distribution of smoking frequency in our data set (ie, mothers commonly reported either regular smoking or no smoking), our use of a binary smoking variable is unlikely to impact our effect estimates.Opioids were used to treat a wide variety of conditions in our study, and the indications for opioid treatment were similar among case and control mothers. Confounding by indication is, therefore, unlikely to be a significant issue. We agree that women using opioids during pregnancy are likely to be experiencing a stressful situation, which could itself increase the risk for specific birth defects.3Carmichael S.L. Shaw G.M. Yang W. Abrams B. Lammer E.J. Maternal stressful life events and risks of birth defects.Epidemiology. 2007; 18: 356-361Crossref PubMed Scopus (76) Google Scholar However, we have no reason to believe that the stress experienced by case mothers taking opioid medications in early pregnancy differed from that experienced by control mothers.Opioid medications are often used as multiple-component products, with the most common coingredient being acetaminophen. Several studies, including a recent National Birth Defects Prevention Study analysis,4Feldkamp M.L. Meyer R.E. Krikov S. Botto L.D. Acetaminophen use in pregnancy and risk of birth defects: findings from the National Birth Defects Prevention Study.Obstet Gynecol. 2010; 115: 109-115Crossref PubMed Scopus (77) Google Scholar observed no increased risk associated with acetaminophen exposure in early pregnancy.However, as we noted, the effects of other ingredients or concomitant exposures need to be considered. Women who abuse opioids were explicitly excluded from our analysis, so our findings do not apply to them.We agree with Jansson et al that the absolute risk of birth defects among women who are treated with opioids in early pregnancy is unlikely to be greatly increased. The goal of our study was to test specific hypotheses raised by previous investigations that maternal opioid treatment in early pregnancy is associated with certain birth defects in infants. Our findings support this association, but further studies are needed to establish causality. We thank Jansson and colleagues for their interest in our study1Broussard C.S. Rasmussen S.A. Reefhuis J. et al.Maternal treatment with opioid analgesics and risk for birth defects.Am J Obstet Gynecol. 2011; 204: 314.e1-314.e11Abstract Full Text Full Text PDF PubMed Scopus (255) Google Scholar and welcome the opportunity to address their concerns. Recall bias is often raised as a criticism of the case-control study design. However, previous studies have found that this is unlikely to account for associations between maternal exposures and birth defects among infants in studies such as ours.2Khoury M.J. James L.M. Erickson J.D. On the use of affected controls to address recall bias in case-control studies of birth defects.Teratology. 1994; 49: 273-281Crossref PubMed Scopus (69) Google Scholar Moreover, if a recall bias exists in our study, it might be in the opposite direction because the average time between delivery and maternal interview was 11 months for case mothers and 9 months for control mothers. Covariates for our regression models were chosen based on the strength of their relationship with all National Birth Defects Prevention Study birth defects in univariate analyses. Periconceptional alcohol consumption was not a confounder using this approach and thus was not included in our regression models. Additionally, given the distribution of smoking frequency in our data set (ie, mothers commonly reported either regular smoking or no smoking), our use of a binary smoking variable is unlikely to impact our effect estimates. Opioids were used to treat a wide variety of conditions in our study, and the indications for opioid treatment were similar among case and control mothers. Confounding by indication is, therefore, unlikely to be a significant issue. We agree that women using opioids during pregnancy are likely to be experiencing a stressful situation, which could itself increase the risk for specific birth defects.3Carmichael S.L. Shaw G.M. Yang W. Abrams B. Lammer E.J. Maternal stressful life events and risks of birth defects.Epidemiology. 2007; 18: 356-361Crossref PubMed Scopus (76) Google Scholar However, we have no reason to believe that the stress experienced by case mothers taking opioid medications in early pregnancy differed from that experienced by control mothers. Opioid medications are often used as multiple-component products, with the most common coingredient being acetaminophen. Several studies, including a recent National Birth Defects Prevention Study analysis,4Feldkamp M.L. Meyer R.E. Krikov S. Botto L.D. Acetaminophen use in pregnancy and risk of birth defects: findings from the National Birth Defects Prevention Study.Obstet Gynecol. 2010; 115: 109-115Crossref PubMed Scopus (77) Google Scholar observed no increased risk associated with acetaminophen exposure in early pregnancy. However, as we noted, the effects of other ingredients or concomitant exposures need to be considered. Women who abuse opioids were explicitly excluded from our analysis, so our findings do not apply to them. We agree with Jansson et al that the absolute risk of birth defects among women who are treated with opioids in early pregnancy is unlikely to be greatly increased. The goal of our study was to test specific hypotheses raised by previous investigations that maternal opioid treatment in early pregnancy is associated with certain birth defects in infants. Our findings support this association, but further studies are needed to establish causality. Maternal treatment with opioid analgesics and risk for birth defects: additional considerationsAmerican Journal of Obstetrics & GynecologyVol. 205Issue 3PreviewBroussard et al1 utilize a case-control study to conclude there is a relationship between early pregnancy opioid analgesic use and certain birth defects. However, 3 concerns severely limit its future research and clinical usefulness. First, drug use data are collected retrospectively “between 6 weeks and 2 years” postdelivery. This method risks selective recall or confirmation bias, and this extended recall window (with unknown duration between cases and controls) compromises the study's internal validity. Full-Text PDF ReplyAmerican Journal of Obstetrics & GynecologyVol. 205Issue 3PreviewWe appreciate the continued interest in our study and the opportunity to respond to letters from Haas and from ‘t Jong and Koren. We acknowledge that the increased relative risk for certain birth defects that we observed in our study to be associated with early pregnancy opioid analgesic treatment translates to only a modest increase in absolute risk for any of the specific birth defects. This and other previously noted study limitations are always important to keep in mind when interpreting our work; however, taken with previous literature, our findings raise legitimate concerns regarding opioid treatment during early pregnancy and indicate the need for further investigation into the observed associations. Full-Text PDF" @default.
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