Duloxetine and pregnancy outcomes: safety surveillance findings. Int J Med Sci. My daughter is pregnant and has terrible pain due to PGP. Has Cymbalta ever been administered for PGP?
Previous Next. View Larger Image. You can find a more recent post on this topic here: Venlafaxine and Duloxetine: Pooled Analysis Shows No Increase in Risk of Malformations We receive a fair number of questions on the use of duloxetine during pregnancy. Would We Recommend Using Duloxetine? Morgan October 26, at pm. Thanks so much! Findings from the analysis of the AERS data showed no apparent disproportionality in abnormal pregnancy outcomes in patients treated with duloxetine versus all other drugs or selected antidepressants.
Much of the existing published literature on the safety of antidepressants in pregnancy is focused on epidemiological study findings. The topic has been reviewed by Yonkers et al Briefly, while these studies have been an essential vehicle for increasing our understanding of antidepressant safety, their limitations are recognized; the studies rely on clinical reports or self reports, there is often a lack of information on diagnosis of depression and antidepressant use and, in some cases, there is lack of control for confounding factors.
While findings from some studies do suggest an association between antidepressant use and adverse birth outcomes including miscarriage, low birth weight infants, preterm deliveries, congenital abnormalities particularly heart defects , pulmonary hypertension of the newborn and adverse effects on neonatal neurobehavior, other studies have found no such associations.
Considering all published findings to date, a causal relationship between antidepressant use and adverse pregnancy outcomes has not been established. Importantly, potential risks of treatment should be weighed against the risks of untreated depression i. The literature on this topic is heterogeneous and suffers from similar limitations to those outlined above.
Antidepressant discontinuation may increase the risk of a new or worsening episode of major depressive disorder in pregnant women 16 , although this has not been found in all studies 17 ; discontinuation of antidepressant treatment may in turn increase exposure to risk factors for adverse pregnancy outcomes inadequate nutrition, increased exposure to additional medications, and increased alcohol and tobacco use in the mother.
In some studies, untreated maternal depression has been associated with adverse pregnancy outcomes, including miscarriage, low birth weight infants, and preterm delivery reviewed by Yonkers et al Maternal depression has also been documented to negatively impact a child's emotional development.
Newborns of women with untreated depression during pregnancy cry more and are more difficult to console Children of mothers with depression have poor adaptive skills, are at risk of emotional and behavioral problems and are more prone to suicidal thoughts and behavior 19 , There are some limitations to the databases used in this paper.
For cases not captured in the clinical trial setting, details surrounding a pregnancy or pregnancy outcomes that might help in assessing possible association with a suspect drug e. Although it is probable that the majority of pregnant women taking duloxetine are doing so to treat a depressive disorder, this cannot be confirmed; duloxetine has other approved uses in addition to treatment of major depressive disorder, including management of diabetic peripheral neuropathic pain and fibromyalgia, and may also be used in an off label manner; these individual diseases are likely to be associated with different levels of risk for abnormal pregnancy, which cannot be addressed in this study.
Calculating the incidence of abnormal pregnancy outcomes is problematic, even for prospectively-identified cases, with a recognized bias towards reporting abnormal outcomes over normal outcomes. Further bias exists as a result of more diagnostic tests being employed in women with depression, such that there is increased potential for detecting anomalies that would not necessarily be detected in women who are not depressed Additional factors can influence whether or not an AE will be reported and thus the calculated incidence of the event e.
In the case of the AERS database, challenges exist in determining the time at which an exposure occurred in relation to when an AE was observed and reported and thus identification of prospective versus retrospective cases is not possible. Despite these limitations which restrict their use in the determination of causality or the incidence of an event, post-marketing surveillance data do have strengths over those from clinical trials.
They are from a naturalistic setting rather than the controlled environment of a clinical trial, and the number of patients exposed to a medicine after it is commercialized can be considerable compared to that feasible in clinical trials, particularly in situations where drugs have been marketed for some time. In conclusion, while limitations of these data are recognized, the information available to date from these two data sources suggest that the frequency of abnormal outcomes reported in duloxetine pregnancy cases is generally consistent with the historic control rates in the general population.
It is recognized that numbers are small, and the monitoring of the safety of duloxetine in pregnancy will continue. As data continue to accrue, our understanding of the safety of duloxetine use in pregnancy will increase. Patient and healthcare provider reports to manufacturers and to the FDA through MedWatch 22 are valuable for continuing data gathering.
Information relating to use of drugs in pregnancy may also be reported through pregnancy registries, including the Cymbalta Pregnancy Registry 23 , designed to collect prospective data about potential risks of duloxetine exposure during pregnancy.
As with all medications, duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. National Center for Biotechnology Information , U. Int J Med Sci. Published online Feb Author information Article notes Copyright and License information Disclaimer. Hoog, MD. E-mail: moc. All authors are full time employees at Eli Lilly and Company.
PPHN only affects around 1 or 2 out of every 1, newborn babies in the general population, but can be serious. Although there are currently no reports of PPHN in babies of pregnant women who took duloxetine, this may be because duloxetine is not commonly used in pregnancy.
Therefore, if you have taken duloxetine after 20 weeks of pregnancy your doctor may still advise that your baby is born in a unit with neonatal intensive care facilities in case monitoring or treatment for PPHN is required. There is no known link between taking duloxetine in pregnancy and learning or behavioural problems in the child later on in life.
There are, however, no scientific studies that have specifically investigated a link with these problems. Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Taking duloxetine in pregnancy would not normally require extra monitoring of your baby. If you have taken duloxetine around the time of delivery your baby may require extra monitoring after birth because of the possible risk of neonatal withdrawal.
We would not expect any increased risk to your baby if the father took duloxetine before or around the time you became pregnant. If you have any questions regarding the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www. Do you have 3 minutes to complete a short, quick and simple 12 question user feedback form about our bumps information leaflets?
To have your say on how we can improve our website and the information we provide please visit here. Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. I need to take duloxetine throughout my entire pregnancy. Will it cause newborn complications in my baby? When used near delivery, duloxetine might cause temporary lasting a short time symptoms in the baby. Most of the time the symptoms are mild and go away on their own, usually within a few weeks.
Not all babies exposed to duloxetine will have symptoms. In rare cases, some babies may need to stay in a special care nursery for a few days until these symptoms go away. Should I stop taking duloxetine during the pregnancy or wean off it before the third trimester? Studies have shown that when depression is left untreated during pregnancy, there may be increased chances for miscarriage, preeclampsia dangerously high blood pressure , preterm delivery, and low birth weight.
Only you and your healthcare provider know your medical history and can best determine whether or not you should stop taking duloxetine during pregnancy.
Some women can gradually wean off duloxetine during pregnancy. For other women, the effects from stopping duloxetine may be more harmful than the possible risks to the baby if they continue to take it.
The benefits of taking duloxetine for your specific situation and the potential small risks to the baby should be considered before a decision is made. Duloxetine is found in breast milk, usually only in very small amounts. No reports have described harmful effects in breastfed infants.
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