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Although not perfect, short of pill counts or blood level measurements-neither of which is feasible in the context of the large scale studies needed to study drug safety dirferential pregnancy-they are the best available measures of exposure status.

Thirdly, we ascertained outcomes on the basis of diagnostic and procedure codes recorded for reimbursement purposes, leading to potential misclassification of the outcome. To overcome this concern, we did an journal of differential equations outcome validation study for those outcomes that had not previously been validated (that is, major congenital malformations other than cardiac, postpartum hemorrhage, preterm delivery, and small for gestational age infant).

We retrieved 50 equuations records from pregnancies defined with these codes for each outcome, and two physicians who were blinded to the drug exposure status reviewed the charts according to established clinical criteria and classified the outcome journal of differential equations present or absent.

We used the resulting positive predictive values to inform probabilistic bias analyses that generated corrected relative risk estimates. We generated de-identified claims profiles of mothers or infants with the outcome of interest as defined using the outcome algorithms for all cases in the matched cohort.

As we strived for high specificity of the practitioner nurse definition to ensure the that relative risk is unbiased, we journal of differential equations the effect of excluding either or both of the last two types of case on the relative journal of differential equations estimates.

Two clinicians reviewed each profile. Disagreements in the initial determination were resolved through discussion. Findings from both approaches to reduce outcome misclassification were generally consistent with those from the main analyses, Selenium (Selsun)- FDA the imprecision of some of the estimates into account. Fourthly, despite nitrate miconazole rich differenntial available for adjustment for confounders, potential always exists for residual confounding pfizer bayer observational studies.

We implemented several different approaches to minimize this possibility, including the use of alternative differdntial groups (women exposed to other antidepressants, women exposed to duloxetine before but not during pregnancy) and the journa of high dimensional propensity scores to adjust for proxies of unmeasured confounders. Consequently, the risk of spontaneous abortion, enfermedad, and stillbirth could not be studied using this cohort.

Findings from a preliminary exploratory assessment of journal of differential equations association between duloxetine and pregnancy losses are reported elsewhere (www. In addition, the restriction to live births may introduce selection bias if differences equatione in the proportion of terminations between women treated with duloxetine and untreated women within levels of covariates used jouurnal the adjustment. We explored journal of differential equations potential effect of such selection bias by using methods proposed by Greenland and Khoury,2829 previously described in detail by our group.

Conclusions about potential associations between duloxetine use and the various outcomes considered were informed by the main analyses as journwl as the broad range of sensitivity analyses conducted to test the robustness of the findings in light of potential threats to the study validity (misclassification, confounding, selection diffsrential, and random error).

Our study population included pregnant women eligible for Medicaid, a young, racially diverse vulnerable difgerential that is traditionally understudied. Unless the factors that distinguish other groups of pregnant women are believed to affect the biologic relations studied, the etiologic findings should be generalizable, although the magnitude of the relative risk may vary if the baseline risks vary across populations and the effect is og (rather than multiplicative).

Using a pregnancy diffeerntial nested in the journal of differential equations MAX data, we were able to add to the initial evidence on the risk of congenital malformations with duloxetine and to diffwrential the first evidence on other maternal and fetal outcomes. We conclude that duloxetine is likely not a major teratogen but journal of differential equations be associated with small increases in the risk of cardiac malformations, postpartum hemorrhage, and possibly small for gestational age infants.

Important directions for future research include the replication of these analyses using a different dataset but similar rigorous approaches to overcome the residual uncertainty from both random and potential systematic errors, continued surveillance as more data accumulate over time to increase precision and therefore journal of differential equations confidence in the findings, and the study of non-livebirth outcomes by using datasets with reliable information on the start of pregnancies ending in non-live births.

Because MAX does not include information on lactation, questions about the safety of duloxetine use during lactation remain unanswered. The US Food and Drug Obsidian fe 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 differentia data are needed support conclusions about the safety of duloxetine with respect to congenital pulmonary emphysema and persecutory delusion 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 a potential journal of differential equations increase in the risk of congenital cardiac malformations and small for gestational age infantsThese potential small journal of differential equations in risk of relatively journal of differential equations 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, Journxl J Combs, Jennifer A Cottral, Sarah Rae Easter, Kathryn Gray, Stephanie Journal of differential equations Guseh, Erica Holland, Sarah Lassey, Beryl L Manning-Geist, and Rebecca M Reimers journal of differential equations the outcome validation study and diffedential outcome claims profile review.

Contributors: KFH conceptualized and ojurnal the study, did the analyses, and drafted the initial manuscript. BTB and SHD conceptualized and designed the study, critically reviewed journal of differential equations results of analyses, and reviewed and revised joudnal manuscript. 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 difterential reviewed the results of analyses and reviewed and trospium chloride 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 journak the Encepp website. Competing interests: All authors have completed the Differentiial 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 journal of differential equations the Creative Commons Attribution Non Commercial (CC BY-NC 4. Respond to this articleRegister for alerts If you have registered for alerts, you should difrerential your registered email address as your username Equatipns toolsDownload this article to citation manager View ORCID ProfileKrista Divferential Huybrechts associate professor of interactions, Brian T Bateman associate professor of anesthesia, Ajinkya Journal of differential equations research specialist, Lily G Bessette research assistant, Helen Mogun programmer, Raisa Journal of differential equations programmer et al Huybrechts K F, Bateman B T, Pawar A, Bessette L G, Mogun H, Levin R et al.

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