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Paroxetine Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Nov 12, 2021.

Paroxetine is also known as: Brisdelle, Paxil, Paxil CR, Pexeva

Paroxetine Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity (e.g., reduced fetal weight and reversible delay of ossification), offspring mortality, and delayed growth. Animal studies with racemic citalopram have revealed evidence of teratogenicity at doses greater than human therapeutic doses. There are no controlled data in human pregnancy. Human spontaneous abortion has been reported with racemic citalopram.

Neonates exposed to SSRIs late in the third trimester have uncommonly reported clinical findings including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These effects have mostly occurred either at birth or within a few days of birth. These features are consistent with either a direct toxic effect of SSRIs, or possibly a drug discontinuation syndrome; in some cases, the clinical picture is consistent with serotonin syndrome.

Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).

Data from animal studies has shown that escitalopram may affect sperm quality. Human case reports from some SSRIs have shown this effect to be reversible. As yet, the impact of this on human fertility has not been observed.

A study of women with a history of major depression who were euthymic at the beginning of pregnancy, showed women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

To monitor the outcomes of pregnant women exposed to antidepressants, a National Pregnancy Registry for Antidepressants has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of this drug in pregnant women despite potential risks.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Tablets: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
Capsules: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category:
-Tablets: D
-Capsules: X

Comments:
-A pregnancy exposure registry is available.
-Capsule formulations: Menopausal vasomotor symptoms (VMS) do not occur during pregnancy and use may cause fetal harm.
-Patients should be advised to notify their doctor if they become pregnant or intent to become pregnant during therapy.
-Newborns should be monitored if the maternal use of this drug continues into the later stages of pregnancy, particularly, the third trimester.
-Abrupt discontinuation should be avoided during pregnancy.
-Women who discontinued antidepressant use during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant use.

See references

Paroxetine Breastfeeding Warnings

This drug should not be used unless there are no safer alternatives.

Excreted into human milk: Yes

Comments:
-This drug has been considered one of the preferred antidepressants during breastfeeding.
-Mild side effects have been occasionally reported, particularly in infants whose mothers took this drug during the third trimester of pregnancy.
-The American Academy of Pediatrics considers the effects of this drug unknown, but may be of concern, and that others taking an SSRI during pregnancy and postpartum may have difficulty breastfeeding and may require additional breastfeeding support.

Low-dose formulations are usually only indicated for the treatment of menopause and would not be expected to be used in breastfeeding women. The manufacturer of this product recommends discontinuing nursing or discontinuing the drug, taking into the account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Pexeva (PARoxetine)." Synthon Pharmaceuticals Ltd, Chapel Hill, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Paxil (paroxetine)." GlaxoSmithKline, Research Triangle Park, NC.
  5. "Product Information. Paxil CR (paroxetine)." SmithKline Beecham, Philadelphia, PA.
  6. "Product Information. Brisdelle (PARoxetine)." Noven Pharmaceuticals, Inc., New York, NY.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Brisdelle (PARoxetine)." Noven Pharmaceuticals, Inc., New York, NY.
  5. "Product Information. Paxil (paroxetine)." GlaxoSmithKline, Research Triangle Park, NC.
  6. "Product Information. Pexeva (PARoxetine)." Synthon Pharmaceuticals Ltd, Chapel Hill, NC.
  7. "Product Information. Paxil CR (paroxetine)." SmithKline Beecham, Philadelphia, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.