Paroxetine in Pregnancy – Why not?
If you are a healthcare professional, inevitably, questions about the use of antidepressants in pregnancy come up in clinical practice. Why is paroxetine generally avoided in pregnancy?
The primary reason that paroxetine is avoided in pregnancy is that it has demonstrated fetal risks. Through the previous FDA rating system, it was considered an FDA pregnancy rating of D. Fifteen studies have found a statistically significant increase of major congenital malformations, specifically atrial and ventricular septal defects, in babies born to mothers taking paroxetine during the first trimester of pregnancy (Bérard et al., 2016). Cardiovascular defects are most prominently found when paroxetine is taken within the first trimester of pregnancy. The manufacturer recommends if a woman becomes pregnant while taking paroxetine, the medication should be discontinued, and a different antidepressant can be started (2014). However, if another antidepressant isn’t taking the place of Paxil, a taper should be used to avoid intolerable discontinuation adverse effects. Paxil should only be used during pregnancy if the benefit to the mother justifies the risk to the fetus.
Third-trimester exposure to paroxetine can also lead to complications. Infants can display symptoms of antidepressant withdrawal, such as tremors, shivering, jitteriness, weak suckling ability, and lethargy (Thormahlen, 2006). Infants may also be born prematurely, experience respiratory distress, jaundice, and hypoglycemia (2006). Other studies have found a correlation between the maternal use of Paxil and infants with Persistent Pulmonary Hypertension (Huybrechts et al., 2015). If choosing to start an SSRI during late-term pregnancy, SSRIs other than paroxetine should be selected first. It is also crucial to discuss potential risks and benefits of any antidepressant medication with the patient.
It is essential to provide options and support to expecting mothers as depression during pregnancy can also lead to substance abuse, preterm delivery, and increased risk of maternal suicide if left untreated. Untreated depression can also lead to difficulty bonding between the mother and baby and difficulty for the mother to care for her newborn. Psychotherapy options such as Cognitive Behavioral Therapy (CBT) should also be strongly considered for the treatment plan.
Article written by Taylor Gill, PharmD student in collaboration with Eric Christianson, PharmD, BCPS, BCGP.
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Bérard A, Iessa N, Chaabane S, Muanda FT, Boukhris T, Zhao JP. The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;81(4):589-604.
Huybrechts KF, Bateman BT, Palmsten K, et al. (2015) Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA 313(21):2142-2151.
Oyebode F, Rastogi A, Berrisford G, et al. (2012) Psychotropics in pregnancy: Safety and other considerations. Pharmacol Ther 135: 71–77.
Product Information: PAXIL(R) oral tablets, oral suspension, paroxetine HCl oral tablets, oral suspension. Apotex Corp. (per FDA), Weston, FL, 2014.
Thormahlen GM. Paroxetine use during pregnancy: is it safe? Ann Pharmacother. 2006;40(10):1834-1837.