Zoloft and It's Birth Defects

(May 5, 2012) – Doctors prescribe Zoloft for use by patients suffering from depression, panic disorder, social anxiety disorder, and obsessive compulsive disorder. Zoloft (sertraline hydrochloride) is an anti-depressant, also known as Selective Serotonin Reuptake Inhibitor (SSRI).  This medication is taken orally, and the active ingredient is absorbed into the bloodstream.    Medical evidence suggests that women taking Zoloft during pregnancy may expose the fetus to high concentrations of the drug. This may result in serious life-threatening birth defects including pulmonary hypertension, cleft lip or palate, heart abnormalities and neural tube defects. Zoloft was introduced in 1991 and continues to be one of the most commonly prescribed medications for individuals diagnosed with one or more types of depression.

When taken during pregnancy, Zoloft has been associated with devastating birth defects such as:

–      three times the risk of infant heart defects

–      six times the risk of persistent pulmonary hypertension in newborns (PPHN)

–      spina bifida/neural tube defects

–      club foot

–      abdominal and cranial birth defects

A study reported in the New England Journal of Medicine found babies prenatally exposed to Zoloft face a 50 percent increased risk of any cardiac defects.

Brain/Spine Defects:  An article published in June 2007 issue of New England Journal of Medicine found babies exposed to SSRI anti-depressants faced a higher risk of the following congenital defects:

–              cleft lip/palate – 50% increase risk

–              craniosynostosis – 80% increased risk

–              organ/abdominal defects

–              omphalocele – nearly 6 times increased risk for babies prenatally exposed to Zoloft

–              gastroschisis – 30% increased risk for babies exposed to an SSRI before birth

–              bladder exstrophy

Other Birth Defects:

–              anal atresia – more than 4.4 times the risk

–              club foot – risk more than doubles (2.4 times)

–              hypospadias – 20% increased risk

–              cryptorchidism – (undescended testicles)

Infant Heart Defects Associated with Zoloft:  According to a study published in the British Medical Journal, Zoloft was shown to triple the risk of infant heart defects. These significant results from the Zoloft studies are the reasons behind the FDA requiring Pfizer to change the drug’s label, warning how serious the risks are to unborn children. In 2005, the FDA added a black box warning to Zoloft (and other anti-depressants) regarding pediatric suicidal behavior. This is the most severe warning issuable a drug may receive.

Another study published by the New England Journal of Medicine in 2007 found a “significant association” between Zoloft and septal defects. Congenital (from birth) septal defects lead to heart stress through improper circulation of blood and are usually life-threatening. It was also found in this study that mothers who took Zoloft during pregnancy double the risk of having an infant born with septal defects.

Persistent Pulmonary Hypertension in Newborns: (PPHN) – Research from a 2006 study published in the New England Journal of Medicine found that maternal use of anti-depressants, such as Zoloft, increase the risk of PPHN by six times. The research also showed that PPHN is more likely to occur when the mother took Zoloft in her third trimester.  PPHN is a condition in which the newborn’s circulatory system does not adapt to breathing outside of the womb, which can lead to a lack of oxygen in the infants’ brain and long-term developmental problems.

Spina Bifida/Neural Tube Defects:  Maternal use of anti-depressants, such as Zoloft, during pregnancy may increase the risk of infants born with spina bifida and other neural tube defects (NTDs) of the brain and spinal cord.  Spina bifida is a NTD where the fetal spinal column does not close completely during the first month of pregnancy. It can lead to paralysis.

Club Foot:  Research shows that some women who took anti-depressants throughout their pregnancy gave birth to children with club foot malformations, according to the University of Ulm, Germany’s Institute of Reproductive Toxicity, and Boston University’s Slone Epidemiology Center.

Abdominal and Cranial Birth Defects:  The National Birth Defect Prevention Study of Infants released information that links Zoloft and other anti-depressants to birth defects.

Congenital Abnormalities:  Omphalocele results from a defect in the abdominal wall, and babies with omphalocele are born with the liver, intestines, and occasionally their organs outside of their bodies. Corrective surgery is required. In particularly severe cases, the baby’s abdominal cavity never fully develops, and is therefore too small to accommodate the organs.  Craniosynostosis is a cranial skull defect causing abnormal skull shape.

It is alleged that Pfizer intentionally hid the link between their popular anti-depressant Zoloft and congenital birth defects when taken by pregnant women.  Zoloft was introduced in 1991 for treatment of depression and by 2007, there were nearly 30 million prescriptions, making it the most prescribed anti-depressant in the U.S.  It is alleged that data was available to Pfizer as early as 1996 suggesting their SSRI anti-depressant may increase the risk of problems for children when taken during pregnancy, yet the drug maker failed to provide adequate warnings to consumers or the medical community.

Pfizer willfully failed to warn consumers of the risks in order to maximize profits, resulting in a negligent breach in its responsibilities to the medical community, innocent users of their medication and their unborn children. Is this justice?

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