Paxil Blamed for Birth Defects in Babies

Paroxetine Causes Heart Defects, Pulmonary Hypertension

Oct 20, 2009

During Pregnancy Avoid Paxil, Bhumi Finding Herself

Studies have shown that infants exposed to paroxetine during the first trimester of pregnancy have an increased risk of serious birth defects involving heart and lungs.

Paxil, an antidepressant approved for use in the United States by the FDA in 1992, generating approximately $942 million in annual sales (2.1% of GlaxoSmithKline’s revenue), has recently come under serious scrutiny.

Jurors in a Philadelphia, Pennsylvania state court have found that manufacturer GlaxoSmithKline (GSK) neglected to warn physicians about the risks associated with using Paxil during pregnancy. Their decision awarded the Kilker family, whose baby was born with heart defects, $2.5 million in damages.

GlaxoSmithKline said it plans to appeal the verdict in this case – the first of 600 due to come to trial.

Effects of Paxil in Pregnancy, First Trimester

According to the October 15, 2009 Telegraph article, GSK issued a statement which says in part, "… the scientific evidence does not establish that exposure to Paxil during pregnancy caused [the Kilker baby’s] condition."

In support, however, of the jury’s 10 – 2 finding in favor of the Kilkers, studies have shown that Paxil (paroxetine) puts infants at increased risk for cardiac malformations, pulmonary hypertension, and death:

One Swedish study based on national registry data showed that infants exposed to paroxetine during pregnancy had a 2% increased risk of congenital heart malformations. The observed malformations were primarily ventricular septal defects (VSD) and atrial septal defects (ASD). Some resolved on their own but others required surgical repairs.
A separate retrospective study in the United States using United Healthcare data considered 5,956 infants of mothers who had taken antidepressants during the first trimester of pregnancy. This study found an increased risk for heart malformations for paroxetine exposed infants (1.5%) compared to that for infants exposed other antidepressants (1%); a 50% increase in risk. This study also cited major congenital malformations including cardiovascular defects.
Two other large case-control studies using separate databases, each with greater than 9,000 birth defect cases and more than 4,000 controls found that fetal exposure to paroxetine during the first trimester resulted in a two to three-fold increase in right ventricular outflow tract obstructions.

Paxil During Pregnancy

If a woman becomes pregnant while taking paroxetine, it is important that she and her doctor discuss the potential dangers to her developing baby. Even when the antidepressant’s benefits to the mother justify continuing treatment, serious consideration should be given to switching to an alternative antidepressant.

Effects of Paxil in Pregnancy, Third Trimester

According to GSK’s own literature, newborns who were exposed to Paxil and other SSRIs or SNRIs (selective serotonin and norepinephrine reuptake inhibitors) late in pregnancy have at times developed complications requiring, “prolonged hospitalization, respiratory support, and tube feeding.”

Complications at Delivery

Several Paxil related complications in newborns have been observed immediately upon delivery, including:

respiratory distress
cyanosis
apnea
seizures
temperature instability
feeding difficulty
vomiting
hypoglycemia
hypotonia
hypertonia
hyperreflexia
tremor, jitteriness and irritability
constant crying

Furthermore, “These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.” (GSK, 2009)

Pulmonary Hypertension

While persistent pulmonary hypertension of newborns (PPHN) occurs at a rate of one to two per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality; infants exposed to SSRIs in late pregnancy appear to suffer an increased risk for PPHN.

Reproductive, Lactation Studies – Paxil

Studies have also been conducted on rat and rabbit reproduction. When rats received Paxil in the last trimester of gestation and dosing was continued throughout lactation, there was an increase found in the number of pup deaths during the first four days postpartum.

This effect occurred at approximately one-sixth of the MRHD (maximum recommended human dosage). Yet, a “no-effect” dose for rat pup mortality was not determined. The cause of rat pups’ deaths are still unknown.

Reference

GlaxoSmithKline, Paxil – Prescribing Informantion (PXL:52PI, 2009)
Taber’s Cyclopedic Medical Dictionary. 2005, F.A. Davis Company

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The copyright of the article Paxil Blamed for Birth Defects in Babies in Prenatal Health is owned by Maria Blanco. Permission to republish Paxil Blamed for Birth Defects in Babies in print or online must be granted by the author in writing.