Trintellix During Pregnancy: Weighing The Benefits And Risks

is trintellix safe to take during pregnancy

Trintellix (vortioxetine) is an antidepressant medication used to treat major depressive disorder in adults. While it is important to carefully consider the risks and benefits of any medication during pregnancy, there is limited data on the use of Trintellix specifically in pregnant women. Animal studies have shown evidence of decreased fetal body weight and delayed ossification when administered during pregnancy at high doses, but human data is limited. Some experts recommend avoiding use during the third trimester as neonates exposed during this time may be at risk of severe and/or prolonged side effects, including agitation, seizures, respiratory distress, and feeding difficulties. The decision to continue or discontinue Trintellix use during pregnancy should be made after a careful assessment of the risks and benefits for each individual, and non-pharmaceutical management options should also be considered.

Characteristics Values
FDA Pregnancy Category Not assigned
AU TGA Pregnancy Category B3
Risk Summary Limited data available on the use of this drug in pregnant women to inform a drug-related risk
Animal Testing Results Evidence of decreased fetal body weight and delayed ossification in pups exposed to doses at least 10 times the maximum recommended human dose (MRHD) during ossification
Decreased numbers of live-born pups, early postnatal pup mortality, lower pup weight gain, and developmental delay were observed at maternally toxic doses
No teratogenic effects in rats or rabbits at doses up to 77 and 58 times the MRHD, respectively, given during organogenesis
Human Testing Results No adequate and well-controlled studies of BRINTELLIX in pregnant women
Side Effects Agitation, hyper/hypotonia, hyperreflexia, jitteriness, tremor, seizures, somnolence, respiratory distress, cyanosis, apnea, hypoglycemia, vomiting, feeding disorder/difficulties, temperature instability, irritability, constant crying
Persistent pulmonary hypertension of the newborn (PPHN), serotonin syndrome, and/or withdrawal
National Pregnancy Registry for Antidepressants Established to monitor the outcomes of pregnant women exposed to antidepressants
Breastfeeding Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug

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Trintellix (vortioxetine) is a novel antidepressant used to treat major depressive episodes in adults. While the drug can be beneficial for managing mental health, it is essential to consider its potential risks during pregnancy and breastfeeding. Although there is limited data on Trintellix's effects during pregnancy, it is generally recommended to avoid its use unless clearly needed. The available data suggests that Trintellix use during pregnancy may be associated with an increased risk of complications such as persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation syndrome (PNAS). Some experts recommend avoiding its use during the third trimester as neonates exposed during this period are at risk of developing severe and/or prolonged side effects, including agitation, hyper/hypotonia, seizures, respiratory distress, and feeding difficulties.

When it comes to breastfeeding, Trintellix is not recommended. The drug has been detected in animal milk, but there is limited information on its presence in human milk. The effects of Trintellix on a nursing infant are unknown, and it is unclear whether it could be transferred to the child through breastmilk. As a result, it is generally advised to discontinue breastfeeding or the drug, depending on the importance of the medication to the mother. This decision should be made in consultation with a healthcare professional, carefully weighing the risks and benefits.

The decision to discontinue breastfeeding or the medication should be a careful consideration of the benefits of Trintellix for the mother against the unknown risks to the infant. It is essential to prioritize the health and well-being of both the mother and the child. In cases where discontinuing Trintellix is not an option, mothers may need to formula-feed their infants or explore alternative feeding methods. However, it is crucial to follow the advice of a healthcare professional to ensure the best outcome for both the mother and the child.

While the potential risks associated with Trintellix use during breastfeeding are unknown, it is always better to exercise caution when it comes to the health and safety of infants. Healthcare providers should closely monitor infants exposed to Trintellix during breastfeeding for any potential side effects or complications. Additionally, mothers who choose to discontinue breastfeeding due to Trintellix use can explore alternative feeding methods, such as formula feeding, to ensure their infants receive the necessary nutrition.

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Trintellix may cause serotonin syndrome in neonates

Trintellix (vortioxetine) is an antidepressant used to treat major depressive episodes and major depressive disorder in adults. It is not recommended for use during pregnancy unless clearly needed. There is limited data on the effects of Trintellix on pregnant women and their babies. However, there are some important considerations and risks to be aware of.

Firstly, animal studies have shown that vortioxetine caused developmental delays and decreased fetal body weight in rats and rabbits when administered during pregnancy at doses higher than the recommended human dose. While these studies do not directly translate to humans, they raise concerns about potential risks.

Secondly, some experts recommend avoiding the use of Trintellix during the third trimester of pregnancy. Neonates exposed to Trintellix during this period are at risk of developing severe and/or prolonged side effects, including agitation, hyper/hypotonia, hyperreflexia, jitteriness, tremors, seizures, somnolence, respiratory distress, cyanosis, apnea, hypoglycemia, vomiting, feeding difficulties, temperature instability, and constant crying. These side effects can arise within 24 hours of delivery and vary in severity, with some neonates requiring intensive care and prolonged hospitalization.

Of particular concern is the risk of serotonin syndrome in neonates exposed to Trintellix in utero. Serotonin syndrome is a potentially serious condition that can occur when there is excessive serotonin activity in the body. Symptoms can include agitation, tremors, seizures, and respiratory distress. In the context of Trintellix exposure, serotonin syndrome in neonates can be life-threatening and requires immediate medical attention.

Additionally, there are theoretical concerns that gestational exposure to Trintellix may increase the risk of persistent pulmonary hypertension of the newborn (PPHN), a potentially serious condition. While there is no conclusive evidence to support this link, the available data is insufficient to rule it out completely.

In summary, while Trintellix may be suitable for use during pregnancy after a careful individualized assessment of risks and benefits, it is essential to consider the potential risks to the fetus, including serotonin syndrome and other severe side effects. Close monitoring of neonates exposed to Trintellix in utero is crucial to identify and manage any potential complications.

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Trintellix may cause decreased foetal weight and developmental delays

Trintellix (vortioxetine) is an antidepressant medication used to treat major depressive disorder in adults. While it can be beneficial for managing mental health, there are some concerns about its safety during pregnancy.

When considering Trintellix use during pregnancy, it is essential to weigh the potential risks and benefits. Currently, there is limited data available on the effects of Trintellix on pregnant women and their babies. Animal studies have shown that Trintellix can cause decreased foetal weight and developmental delays when administered during pregnancy at doses higher than the recommended human dosage. These effects were observed in rats and rabbits at doses 15 and 10 times the maximum recommended human dose, respectively. Additionally, there was a decrease in the number of live births, increased early postnatal mortality, and delayed development in the offspring.

In human pregnancies, the incidence of malformations associated with Trintellix exposure has not been established. However, it is important to note that all pregnancies, regardless of drug exposure, carry a background rate of 2 to 4% for major malformations and 15 to 20% for pregnancy loss. While there is no good evidence of an association between Trintellix and miscarriage, congenital malformation, intrauterine death, low birth weight, or preterm delivery, an increased risk cannot be excluded due to limited data.

Some experts recommend avoiding the use of Trintellix during the third trimester of pregnancy. Neonates exposed to Trintellix during this period are at risk of developing severe and/or prolonged side effects, including agitation, hyper/hypotonia, hyperreflexia, jitteriness, tremors, seizures, somnolence, respiratory distress, cyanosis, apnea, hypoglycemia, vomiting, feeding disorders/difficulties, temperature instability, and constant crying. These side effects can vary in severity and duration, and some neonates may require intensive care support and prolonged hospitalization.

The decision to use Trintellix during pregnancy should be made after a careful individualized assessment of the risks and benefits by a healthcare professional. It is crucial to consider the impact of untreated maternal depression on both the mother and the newborn. In some cases, discontinuing antidepressant medication during pregnancy may lead to a relapse of depression, which also carries risks for both the mother and the baby.

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Trintellix may increase the risk of postpartum haemorrhage

Trintellix (vortioxetine) is a novel antidepressant used to treat major depressive episodes in adults. While it is crucial to address mental health concerns during pregnancy, the potential risks of Trintellix use during this period should be carefully considered.

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned of a small overall increased risk of postpartum haemorrhage (PPH) associated with the use of selective serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) in the month before delivery. As Trintellix has a similar mechanism of action to SSRIs, there are theoretical concerns that its use during pregnancy could also elevate the risk of PPH. Although no studies have directly investigated this association with Trintellix, the available data does not disprove the possibility. Therefore, the risk of PPH attributable to Trintellix use cannot be excluded.

The decision to continue or discontinue Trintellix during pregnancy requires a careful assessment of the risks. On the one hand, discontinuing antidepressant medication during pregnancy may lead to a relapse of major depression, which has its own risks for both mothers and newborns. On the other hand, the potential risk of PPH attributable to Trintellix use should not be overlooked.

It is recommended that healthcare providers conduct an individualised assessment of the risks and benefits of using Trintellix during pregnancy for each patient. Non-pharmaceutical management of depression and/or anxiety may be considered during pregnancy, especially if the patient is not stabilised on Trintellix prior to conception. In cases where treatment with Trintellix is continued, it is advised to use the lowest effective dose. Additionally, prescribers should ensure maternal compliance with heparin self-administration in pregnant women with risk factors for venous thromboembolism.

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Trintellix may increase the risk of persistent pulmonary hypertension of the newborn (PPHN)

Trintellix (vortioxetine) is an antidepressant used to treat major depressive episodes in adults. It is not recommended for use during pregnancy unless clearly needed. There is limited data on the effects of Trintellix on pregnant women and their babies. However, according to the available information, Trintellix may increase the risk of persistent pulmonary hypertension of the newborn (PPHN).

PPHN is a rare condition that affects one to two newborns per 1,000 live births in the general population. It is associated with substantial neonatal morbidity and mortality. Several epidemiological studies suggest a positive statistical association between SSRI (selective serotonin reuptake inhibitor) use during pregnancy and an increased risk of PPHN. Trintellix is not an SSRI but has a similar mechanism of action, so there are concerns that it could also increase the risk of PPHN.

The exact risk of PPHN associated with Trintellix use during pregnancy is unknown. There are no published data identifying an association between gestational exposure to Trintellix and PPHN. However, the available data is insufficient to rule out this possibility, and an increased risk cannot be excluded. While the absolute risk is likely to be low, the potential seriousness of PPHN warrants discussion with women considering Trintellix use during pregnancy.

The decision to use Trintellix during pregnancy should be made after a careful individualized assessment of the risks and benefits. Non-pharmaceutical management of depression and/or anxiety may be considered during pregnancy, especially in the third trimester. However, discontinuing or changing medication also carries risks, as untreated maternal depression and relapse of depressive symptoms have their own risks for both mothers and newborns.

Frequently asked questions

Trintellix is a drug used to treat major depressive episodes in adults. There is limited data on the effects of Trintellix on pregnant women, but it is known to cause developmental delays in animal studies. While it is not recommended for use during pregnancy, the potential benefits may justify its use in some cases if prescribed by a doctor.

Neonates exposed to Trintellix during the third trimester are at risk of developing severe and/or prolonged side effects such as seizures, respiratory distress, and feeding difficulties. These side effects usually arise within 24 hours of delivery and vary in severity.

Alternatives to Trintellix include non-pharmaceutical management of depression and/or anxiety. However, the decision to discontinue treatment, change medication, or reduce the dose should be carefully weighed against the risk of maternal relapse.

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