History of Paxil
In 1992 paroxetine (American trade name Paxil), created by GlaxoSmithKline, was approved by the Food and Drug Administration as a drug to treat the effects of depression in patients. In the early 2000’s GlaxoSmithKline faced many complaints to the effectiveness of Paxil and the many associated risks in taking the drug. In 2004 they agreed to publish on their website the results of clinical testing performed on the drug. As a result, they would later settle a class action suit for alleging promotion of the drug for use by children and failing to disclose information regarding the drug’s effectiveness.
In 2005, GlaxoSmithKline issued a letter to doctors alerting them of the elevated risk of heart defects to a fetus in mothers taking Paxil during the first trimester. The company also revised the labeling to reflect the elevated risk. On October 13th, 2009 the first of almost 600 lawsuits brought forth against GlaxoSmithKline saw a verdict of 2.5 million dollars awarded to the family of an affected child.
Paxil and Birth Defects
In December of 2005 a Swedish study found that women who took Paxil in the early stages of pregnancy were twice as likely to give birth to a child who suffered from heart defects. The study also found that Paxil increased the risk of general birth defects by 50%. A different study found that mothers who took the drug after 20 weeks of pregnancy were six times more likely to give birth to a child with persistent pulmonary hypertension (PPHN). As a result, the FDA issued a Public Health Advisory for the use of Paxil during pregnancy. Originally introduced as a Category C pregnancy risk, Paxil was now deemed a Category D pregnancy risk, meaning that there is clear risk to a human fetus when taken during gestation. This category change, the “dear doctor” letter and the Public Health Advisory all came after the drug had been on the market for more than 10 years.
Possible Birth Defects in Newborns from Paxil:
- Heart – A majority of studies found that the heart defects associated with Paxil are septal defects in both the atrium and ventricle. Septums are walls in the heart that divide the right and left side. The left side of the heart is used to pump oxygenated blood throughout the body while the right side pumps blood to the lungs to become oxygenated. With this defect, the heart walls contain holes and do not separate the two different types of blood. This leads to the heart pumping blood to the body that is not oxygenated and pumping blood to the lungs which has already been oxygenated. The heart will subsequently have to work harder, causing high blood pressure and enlargement of the heart. Over time, there can also be damage to the blood vessel walls. These defects can range from medically insignificant to very severe depending on the size of the holes in the heart.
- Persistent Pulmonary Hypertension – Also known as persistent fetal circulation, this defect affects the newborn’s lungs and blood flow. After birth, the newborn’s blood circulation dramatically changes, due to the new need for breathing on its own. If this defect is present, the newborn’s circulatory system will revert back to how it operated as a fetus and bypass the lungs in its distribution of blood. As a consequence, vital organs may fail from lack of highly oxygenated blood.
- Abdominal – An abdominal defect that could result due to the use of Paxil is omphalocele. Omphalocele is present when a newborn’s intestine or other abdominal organs protrude from the navel after birth.
- Cranial – Craniosynostosis is a defect which causes one or more sutures on a newborn’s head to close earlier than normal. This can lead to an abnormally shaped head in newborn children.
- Clubfoot – Clubfoot is a condition at birth where an infant’s feet are turned inward and downward. Treatment of this disease usually involves turning the foot and placing it in a cast.
- Neural Tube – Neural tube birth defects are those of the brain and spinal cord. Spina bifida is one of the most common neural tube defects in which the fetal spinal column never completely closes during the first month of gestation. As a result, nerve damage, and potentially leg paralysis, is a common symptom. Ultimately, death can also be associated with neural tube defects.
The skilled Raleigh personal injury lawyers of Hardison & Cochran have represented clients who have been injured because of dangerous prescription drugs. Hardison & Cochran have the resources to hire the necessary experts and investigators to fight big drug companies. Our experience can help you level the playing field.
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