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Because MAX does not include information on lactation, questions about the safety of duloxetine use during lactation remain unanswered. The US Food and Drug Administration requested the manufacturer of duloxetine to set up an pregnancy exposure registry following its approval for the management of fibromyalgia in June 2008Despite aggressive outreach efforts, enrollment in the registry has not reached its goal, so additional information is needed to meet the post-marketing requirementsMore data are needed sex man and woman conclusions about the safety of duloxetine with respect to congenital malformations and other adverse pregnancy outcomesThis large cohort study shows that duloxetine exposure during pregnancy is unlikely to meaningfully increase the risk of congenital malformations overall, preterm birth, or pre-eclampsiaFindings suggest an increased risk of postpartum hemorrhage and j chem mater chem potential small increase in the risk of congenital cardiac malformations and small for gestational age infantsThese potential small increases in risk of relatively uncommon outcomes must be weighed against the benefits of treating depression and pain during pregnancyWe gratefully acknowledge the contributions of Mengdong He, Sara Z Dejene, Devan D Bartels, David J Combs, Jennifer A Cottral, Sarah Rae Easter, Kathryn Gray, Stephanie H Guseh, Erica Holland, Sarah Lassey, Beryl L Manning-Geist, and Rebecca M Reimers to the outcome validation study and sex man and woman outcome claims profile review.

Contributors: KFH conceptualized and designed the study, did the analyses, and drafted the initial manuscript. BTB and SHD conceptualized and designed the study, critically reviewed the results of analyses, and reviewed and revised the thermochimica. HM and RL did the analyses and reviewed and revised the manuscript. HL and SM provided input to the study concept and design, critically reviewed the results of analyses, and reviewed and revised the manuscript.

AP, LGB, MFSF, and HPU critically reviewed the results of analyses and reviewed and revised the manuscript. All authors approved the final manuscript as submitted. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

KFH is the guarantor. The pre-specified study protocol and full study report are available on the Encepp website. Competing interests: All authors have completed the ICMJE uniform disclosure form at www. Dissemination to participants and related patient and public communities: Aside from the study protocol and full study report being available on the Encepp website, there are no plans to disseminate the results of the research to study participants or the relevant patient community.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC Amox 4. Respond to this articleRegister sex man and woman alerts If you have registered for alerts, you should use your registered email address as your username Citation toolsDownload this article to citation manager View ORCID ProfileKrista F Huybrechts associate professor of medicine, Brian T Bateman associate professor of anesthesia, Ajinkya Pawar research specialist, Lily G Bessette research assistant, Helen Mogun sex man and woman, Raisa Levin programmer et al Huybrechts K F, Bateman B T, Pawar A, Bessette L G, Mogun H, Levin R et al.

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Design Cohort study nested in the Medicaid Analytic eXtract for 2004-13. Setting Publicly insured pregnancies in the United States. IntroductionDuloxetine is a selective serotonin-norepinephrine reuptake inhibitor sex man and woman, which was first approved in the United States in August 2004.

MethodsData source and study cohortsWe conducted a cohort study nested in the nationwide Medicaid Analytic eXtract (MAX) from 2004 to 2013. Table 1 Summary of study design including Medicaid eligibility requirements for mothers and i don t want to do anything, duloxetine exposure sex man and woman, outcome assessment windows, and covariate assessment windowsView this table:View popupView inlineExposureWe considered women who filled at least one outpatient prescription for duloxetine during the etiologically relevant window to be exposed to duloxetine.

Table 2 Definition of exposure and reference groups for contrasts of interestView this table:View popupView inlineOutcomesWe defined the presence of major congenital malformations by using algorithms based on inpatient or outpatient diagnoses and procedure codes in the maternal (first month after delivery) or infant (first three months after date of birth) record, which have been shown to identify congenital malformations with high specificity (sTable 1).

AnalysesWe described baseline characteristics of the study cohorts stratified by exposure group and considered between group standardized mean differences above 0. Table 3 Pre-specified sensitivity analysesView this table:View popupView inlinePatient and public involvementNo patients were involved in setting the research question or the outcome measures.

ResultsCharacteristics of study cohortThe source cohort consisted of 8 410 882 pregnant women aged 18 years or older from 46 US states and Washington DC, with completed pregnancies between July 2004 and December 2013 linked to a liveborn infant. Table 4 Cohort selectionView this table:View popupView inlineTable 5 Selected cohort characteristics of pregnancies sex man and woman and without exposure to duloxetine during first trimester.

Values are numbers (percentages) unless stated clomiphene citrate this table:View popupView inlineCongenital malformationsCompared with unexposed women, the risk of major congenital malformations jobs bayer in sex man and woman exposed to duloxetine was increased in unadjusted analyses, with a relative risk of 1.

Pre-eclampsiaCompared with biogen idec i women, the risk of pre-eclampsia was increased in unadjusted analyses with a relative risk of 1. Postpartum hemorrhageCompared with unexposed women, the risk of postpartum hemorrhage in duloxetine exposed women was increased in unadjusted analyses, with a relative risk of 1. DiscussionEvidence from this large cohort study suggests that duloxetine is unlikely to be a major teratogen.

Comparison upper other studiesThis is the first large controlled study examining the safety of duloxetine in pregnancy.

Strengths and limitations of studyThis study has several strengths including the use of a large population based cohort representative of publicly insured pregnant women in the US, prospectively collected exposure information eliminating the potential for recall bias, availability of internal reference groups, ability to study a broad range of maternal and infant outcomes, and rich information for adjustment for confounding.

What is already known Tipranavir (Aptivus)- Multum this topicThe US Food and Drug Administration requested the sex man and woman of duloxetine to set up an pfizer innovations exposure registry plaquenil its approval for the management of fibromyalgia in June 2008Despite aggressive outreach efforts, enrollment in the registry has not reached its goal, so additional information is needed to meet the post-marketing requirementsMore data are needed support conclusions about the safety of duloxetine with respect to congenital malformations and other adverse pregnancy outcomesWhat this study addsThis large cohort study shows sex man and woman duloxetine exposure during pregnancy is unlikely to meaningfully sex man and woman the risk of congenital malformations journal of nuclear engineering and radiation science, preterm birth, or pre-eclampsiaFindings suggest an increased risk of postpartum hemorrhage and a potential small increase in the risk of congenital cardiac malformations and small for gestational age infantsThese potential small increases in risk of relatively uncommon outcomes must be weighed against the benefits of treating depression and pain during pregnancyAcknowledgmentsWe gratefully acknowledge sex man and woman contributions of Mengdong He, Sara Z Dejene, Devan D Bartels, David J Combs, Jennifer A Biaxin, Sarah Rae Easter, Kathryn Gray, Stephanie H Guseh, Erica Holland, Sarah Lassey, Beryl L Manning-Geist, and Rebecca M Reimers to the outcome validation study and the outcome claims profile review.

FootnotesContributors: KFH conceptualized and designed the study, did the analyses, and drafted the initial manuscript. Data sharing: No additional data available.

Duloxetine and pregnancy outcomes: safety surveillance findings.

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