A French team of researchers led by S. Favrelière et al. published an article in L’Encephale titled “Treatment of depressed pregnant women by selective serotonin reuptake inhibitors: risk for the foetus and the newborn” in June, 2010 and provided further insights into the risks associated with selective serotonin reuptake inhibitor (SSRI) use during pregnancy posed to unborn children.
Reviewing literature, the team found that “The prevalence of depression during pregnancy is of around 10 to 20% of the population of childbearing women” and states that “Depression is often misdiagnosed and underestimated in pregnant women. Starting a pharmacological treatment for depression in these women is not easy because data concerning the safety of antidepressants during pregnancy are still unclear.”
In addition to problems for expecting mothers, “Foetal development is also affected and adverse outcomes such as prematurity, low birth weight, irritability, and sleep disorders are frequent.” However, non-pharmaceutical treatment for maternal depression may be insufficient, thus women and doctors must weigh risks and make decisions on a case-by-case basis.
“In general, drugs have a low teratogenic potential, only 4 to 5% of malformations are iatrogenic. Teratogenic risk is high between conception until the end of the second month of gestation. Safety of SSRIs treatment during pregnancy and potential risk for the foetus and newborn were unquestioned before publication, in the late 2005, of some alarming data concerning a possible teratogenic effect. Studies showed an increased risk for all congenital malformations with SSRIs and particularly with paroxetin. A few studies after 2005 have also found an association between prenatal exposure to SSRIs (especially paroxetin) and congenital malformations.”
For clarity, “paroxetin” (or “paroxetine”) is the chemical name for Paxil, an SSRI manufactured by GlaxoSmithKline (GSK). The authors continue: “Numerous studies in pregnant women have shown that SSRI treatments are associated with a significant increase of spontaneous abortion, preterm birth, and low birth weight. Exposure to SSRIs in late pregnancy has been associated with a three-fold increased risk of neonatal behavioural syndrome, including signs of withdrawal or serotonin impregnation. Restlessness, poor tone, respiratory distress, hypoglycaemia were the most frequent signs. … Recent studies have also documented an increased risk of persistent pulmonary hypertension and cases of cerebral haemorrhage have been described.”
Concluding “Although a number of studies revealed that SSRIs are not teratogenic, some of them showed congenital malformations associated with use of these antidepressants; in particular an increased risk of cardiac defects with paroxetin”, studies like this can be used as evidence in a Paxil® birth defects lawsuits to demonstrate the GSK knew, or should have known, the risks associated with the use of this drug during pregnancy.
If you or a loved one used Paxil and gave birth to a child with a congenital malformation, you may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of Paxil® birth defects lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.
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