Sunday, May, 20, 2012

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Zoloft Birth Defects

Zoloft, an antidepressant drug belonging to a group of drugs known as selective serotonin reuptake inhibitors (SSRIs), is classified as pregnancy Category C by the U.S. Food and Drug Administration (FDA). This classification means that Zoloft can potentially cause harm to a developing fetus if it is used during pregnancy. Doctors intending to prescribe Zoloft to pregnant women who are diagnosed with depression should only do so after careful consideration of the drug’s benefits for the patient’s condition while also bearing in mind its potential risk to unborn babies. Women who become pregnant while taking Zoloft should consult their doctors immediately. Zoloft has been linked to birth complications particularly during the third trimester of pregnancy.

Zoloft and Pregnancy Category C

The FDA has a pregnancy classification system to grade drugs according to the amount of potential risk they have on fetuses or unborn babies. In the United States, a category C classification means that the drug has not been subjected to any clinical study on a human fetus but has been found to cause harm to animal fetus. Drugs that have not been studied on pregnant women or animals before, of which their risks or effects on the developing fetus are largely unknown, also fall under the category C classification by FDA.

Despite its classification, many doctors still prescribe Zoloft to pregnant women based on the assumption that humans do not respond in similar ways to certain drugs as animals do. Therefore, some doctors continue to prescribe classification C medication to their pregnant patients if they believe that the drug’s ability to treat their patients’ conditions far exceeds its potential risk to the unborn child.

Congenital Heart Defects

The FDA has repeatedly warned against the use of SSRI medications such as Zoloft during pregnancy as there is a high risk that the drug can have adverse effects on the fetus. Zoloft has been identified as the cause behind the increased risks of congenital heart defects among unborn children. The most common forms of heart birth defects linked to Zoloft are Atrial Septal Defects (ASD) or Ventricular Septal Defects (VSD).

Both ASD and VSD are congenital birth defects more commonly known as “holes in the heart”, meaning that an abnormal opening occurs either in the dividing wall between the upper filling chambers of the heart, as in the case of ASD, or in the dividing wall between the left and right ventricles of the heart, as in the case of VSD.

Persistent Pulmonary Hypertension of the Newborn (PPHN)

According to a study published in The New England Journal of Medicine in 2006, scientists found a direct correlation between the increased risk in babies born with Persistent Pulmonary Hypertension of the Newborn (PPHN) and the use of SSRI medications such as Zoloft by mothers during pregnancy.

As a result of the study, the FDA issued a Public Health Advisory warning against the use of Zoloft during pregnancy, which can potentially cause severe harm to the fetus particularly in the increased risk of newborns developing PPHN.

PPHN occurs when a newborn’s blood circulation fails to make the normal transition from fetal to normal newborn circulation, thus causing breathing problem and respiratory distress. PPHN can cause long term health complications requiring treatment and intensive care and in more serious cases, can result in hearing loss or even death.

Abdominal and Cranial Birth Defects

More information related to SSRIs has also been released by the National Birth Defects Prevention Study of Infants, which found a direct link between the use of SSRI medications such as Zoloft and the increased risks of two forms of birth congenital abnormalities namely Omphalocele and Craniosynostosis.

Omphalocele is a physical malformation that occurs during the 11th week of the pregnancy when the growing abdomen organs fail to return back to the abdomen area resulting in the newborn’s intestine or abdomen organs sticking out at the belly button area.

Craniosynostosis, on the other hand is a congenital abnormality of the skull in which the sutures between the skull bone plates close up earlier than normal, resulting in an increased pressure inside the skull that causes a misaligned asymmetrical shape of the head.

The above two conditions cause life-long physical and emotional distress; treatment is usually by surgery, which can pose high risks to the baby depending on the severity of the condition and the health of the baby.

Known Zoloft Side Effects

Pregnant mothers who use Zoloft are also at risk of pregnancy complications resulting in birth defects including:

  • Congenital Heart Defects particularly Atrial and Ventricular Septal Defects;
  • Persistent Pulmonary Hypertension of the Newborn (PPHN);
  • Abdominal congenital defects such as Omphalocele;
  • Cranial congenital defects such as Craniosynostosis.