Paxil and the Risk of Birth Defects

Introduction

Recent studies have shown that women who take Paxil during the first three months of gestation are more likely to give birth to babies with Paxil birth defects, as compared to women who do not take any antidepressants during pregnancy. These Paxil birth defects can be life-threatening, and may include serious congenital problems, the most common of which are Paxil heart defects.

Main Digest

What is Paxil?

Paroxetine Hydrochloride, or better known as Paxil (PAX-il), is an orally administered psychotropic drug. In tablet and oral suspension form, Paxil is used in the treatment of major depressive disorder, social anxiety disorder, obsessive compulsive disorder (OCD), panic disorder (PD), generalized anxiety disorder (GAD), and post-traumatic stress disorder (PTSD). Its pharmaco-dynamics is presumed to be linked to enhancing the serotonergic activity in our central nervous system which results from inhibition of the re-uptake of serotonin. As a selective serotonin re-uptake inhibitor, Paxil acts within the brain to increase serotonin.

Paxil and its Side Effects

While Paxil is approved by the FDA for the treatment of depression and other psychiatric disorders mentioned above, a recent alert was released about studies done suggesting that Paxil was observed to have teratogenic side effects, increasing the risk for birth defects. This is especially so when taken during the first three months of pregnancy, the intake of which particularly results in cardiovascular malformations.

In December 8, 2005 the FDA issued a Public Health Advisory based on U.S. and Swedish studies which showed that infants exposed to Paxil during pregnancy (n = 815) had a significant increase in heart defects. These defects were primarily atrial and ventricular septal defects. These septal defects are conditions in which walls of the sides of the heart are not fully and completely developed. In two large case-control studies using separate database, each with greater than 9,000 birth defect cases and more than 4,000 controls, it was observed that the use of Paxil during the first trimester was associated with a 2- to 3-fold increased risk of right ventricular outflow tract obstructions.

Much concern has risen over Paxil such that this drug's label has been changed from Pregnancy Category C to Pregnancy Category D.

Aside from cardiac malformations, other Paxil birth defects include the following:

Persistent pulmonary hypertension (PPHN)

The newborn presents with high pressure in their lung blood vessels and are unable to get enough oxygen in the bloodstream. PPHN is a serious and life-threatening emergency that generally occurs soon after the birth of the newborn. On July 19, 2006 the FDA issued another advisory for seven antidepressant drugs including Paroxetine based on a study which observed that PPHN was six times more common in babies whose mothers took the drug after the 20th week of gestation compared to mothers who did not take an antidepressant.

Abdominal Birth Defects

Omphacele is type of abdominal wall defect in which the intestine, liver, and other abdominal organs remain outside the abdomen in a sac because of a developmental defect. These organs are usually found to be protruding from the navel. In September 2005, GlaxoSmithKline sent a letter to healthcare professionals advising them of a label change based on data from the National Birth Defects Prevention Study of Infants. This study showed that women taking Paxil were more likely to have an infant with omphacele than those who were not taking it. Some 36% of all SSRI exposures were reported to be with Paxil.

Cranial Birth Defects

The same letter in 2005 also reported the risk of giving birth to infants with Craniosynostosis. This is a condition in which connections between sutures-skull bones prematurely fuse or close by ossification during the first year of life, changing the growth pattern of the skull resulting in an abnormally shaped skull.

• Difficulties with breathing
• Seizures
• Vomiting
• Low blood sugar
• Tremors, jitters
• Muscle rigidity
• Irritability
• Feeding difficulties
• Constant crying

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Cite This Page (APA): Langtree, I. C. (2010, December 17 - Last revised: 2024, March 31). Paxil and the Risk of Birth Defects. Disabled World. Retrieved September 11, 2024 from www.disabled-world.com/disability/legal/paxil-birth-defects.php

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