(May 27, 2012) – In 2005, the U.S. Food and Drug Administration (FDA) issued a warning that anti-depressant drugs with a Selective Serotonin Reuptake Inhibitor (SSRI), such as Paxil, could put children at risk of birth defects if taken by pregnant mothers. There are millions of at-risk children born to mothers who were prescribed such medications.
This warning came after the FDA reviewed a study conducted by Paxil manufacturer, GlaxoSmithKline. The FDA warned the medication could cause a range of birth defects. Data was collected from more than 3,500 women taking Paxil during the first three months of pregnancy. The medication has not been banned for pregnant women, though the warning has been upped from Class C to Class D, meaning that there is evidence that the drug poses a known risk to unborn children. Although it is not recommended for expectant mothers to take this medication, doctors may continue to prescribe it if the benefits for the mother outweigh the risk posed to the fetus. It is known that there is a common presence of depression in pregnant women.
Drugs like Paxil and Zoloft have been found to cause birth defects in children of pregnant mothers taking these drugs by experts with the National Birth Defect Prevention Study of Infants, the FDA, New England Journal of Medicine, University of Ulm and Aarhus University in Denmark, University of California at San Diego, and Boston University.
The birth defects, which were found directly related to mothers who took Paxil during pregnancy are: skull defects, lung conditions, abdominal defects, club foot, brain deformities, heart defects, and spinal defects.
Paxil has been on the market in the U.S. since 1992, and is one of the most widely prescribed anti-depressants on the market. Ten years after it became available, the LA times published an article (December 15, 2002) estimating that in that year alone, 37 million prescriptions were filled. Just five years later, in 2007, the FDA calculated that 19.7 million prescriptions of Paxil were filled.
In 2010, annual reports showed that Paxil’s manufacturer, GlaxoSmithKline, earned more than $5 billion in profits. GlaxoSmithKline has spent approximately $1 billion to date to settle litigation claims regarding birth defects, according to an article published in Bloomberg News on July 20, 2010. On average, settlements amounted to $1.2 million in approximately 800 individual cases.
Even families that have yet to file a claim still retain their legal rights, despite the fact that hundreds of cases have already settled.
Paxil birth defects include:
– Persistent Pulmonary Hypertension in the Newborn (PPHN)
– Congenital (present at birth) heart defects
– Neural tube defects (spina bifida)
– Craniosynostosis
– Infant omphacele
– Club foot
– Anal atresia
– Lung defects
Persistent Pulmonary Hypertension in the Newborn (PPHN) is a life-threatening disorder in which a newborn’s arteries to the lungs remain constricted after birth, resulting in an abnormal blood flow through the heart and lungs, and insufficient oxygen delivery throughout the baby’s body. Surgery is required in serious cases.
Spina Bifida – During the first month of pregnancy, the two sides of the spine join together to cover the spinal cord, spinal nerves, and the tissues covering the spinal cord. Spina bifida refers to any birth defects involving incomplete closure of the spine. This requires major surgery, physical therapy for the child, and in some cases, special apparatus.
Craniosynostosis – A birth defect in which one or more of the joints between the bones of the infant’s skull close prematurely, before the infant’s brain is fully formed. When the baby has craniosynostosis, his or her brain cannot grow in its natural shape, and the head is misshapen. To treat this, the infant usually needs surgery to separate the fused bones. If there is no underlying brain abnormality, the surgery creates adequate space for the brain to grow and develop. Treatment must be done at birth while the baby’s head is still malleable in order to create proper room for the brain to grow and to relieve pressure and re-mold the skull’s shape.
Infant Omphacele – is an abdominal wall defect at the base of the umbilical cord; the infant is born with a sac protruding through the defect, which contains the small intestine, liver, and large intestine. Surgery is required; however, once the omphacele repair is completed, some infants have difficulty eating normally, and may require tube feeding. If the omphacele is large, a caesarean section is necessary.
- Infant Omphalocele
Anal Atresia – is a congenital defect that affects the anus. In this condition, the opening of the anus is blocked or missing entirely. Surgery is the only treatment for anal atresia.
Lung Defects – Although there are many types of lung defects from blood flow to deformity to underdevelopment, these are addressed separately, with varying treatments that can be resolved through incubators or surgery. There is a possibility that the child will have breathing problems for their entire life.
These are very dangerous side effects, and many of these conditions are life long. Although depression is a serious disease, is taking Paxil while pregnant worth passing such horrible side effects on to your unborn child? The manufacturers of these anti-depressants, in this case, GlaxoSmithKline, manufacturer of Paxil, need to warn consumers about the increased risks they are facing when taking these drugs. They are responsible for causing so much pain and sickness to millions of mothers and their babies. Now they really have something to be depressed about.
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