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This anti-depressant drug prescribed to pregnant women can cause serious heart defects, or death, in the newborn child.
IF YOU or a loved one has been injured after taking Paxil®, contact us today!
Background:
Paxil®, is a selective serotonin reuptake inhibitor (SSRI), and has been commonly prescribed in the United States, in the treatment of depression. Paxil® is generically known as paroxetine, and was originally approved by the FDA in 1992. In December 2005, the FDA issued an alert on the drug, following studies that linked the drug with increased risk of heart defects in infants. The FDA also mandated that Paxil included label warnings indicating the risk of birth defects.
Paxil® and PPHN
Paxil has been primarily associated with Persistent Pulmonary Hypertension of the Newborn (PPHN), a life-threatening condition in newborn infants. In newborns with PPHN, the arteries supplying blood to the lungs remain constricted, limiting the amount of blood flowing into the lungs and consequently lowering the amount of oxygen flowing into the bloodstream.
As an antidepressant drug, Paxil® has been designed to essentially act on the neurotransmitter Serotonin, which also plays a role in the development of the fetal heart. Since Paxil® crosses the placenta, when the drug is administered to a pregnant woman, it can have a powerful impact on the developing fetus's organs. Typically, newborns with PPHN are born as full-term or near-term infants without any congenital abnormalities. Yet, shortly after birth they present severe respiratory failure, requiring intubation and mechanical ventilation. Sadly, 10%-20% of these infants succumb to the condition, even after receiving treatment.
Paxil® Birth Defects
Depression in pregnant women is not an uncommon phenomenon. The American Medical Association estimates that over 40,000 pregnant women in the US are being prescribed antidepressants. However, results from varied studies on antidepressant drug treatment at the time of pregnancy bring out disturbing data and conclusions.
A recent study published in the New England Journal of Medicine (NEJM) indicated that infants born to mothers who took antidepressants in the last trimester of pregnancy were six times more likely to be affected by PPHN. Additionally, results from the study indicated that "six to twelve mothers per thousand who use an SSRI after 20 weeks' gestation, are likely to deliver a child with PPHN."
Several studies have now linked Paxil® with other complications in newborn infants. A study published in Teratology Society Abstracts in 2005 indicates that mothers who were on Paxil® treatment were more likely to have babies born with fetal malformation conditions such as craniosynostosis and omphalocele.
Another study based on data from the Swedish national registry indicated that as compared to the entire national registry population, pregnant women who were on Paxil® treatment had two times the risk of bearing an infant with a cardiac defect.
Since March/April 2006, the FDA has updated its information relating to Paxil and the Risk of Birth Defects, quoting early results from two studies which "indicate that women who took Paxil® during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects)." The FDA has also advised health care professionals "not to prescribe Paxil® in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate."
Paxil® Side Effects Lawsuit
If your baby or someone in your family has a baby suffering from Paxil birth defects, it is time to seek legal help now. You have the right to seek compensation for the medical expenses, emotional and physical suffering, and the mental agony caused to you and your loved ones. Please contact our San Antonio Paxil Lawsuit Attorneys for a free review and consultation.
Our San Antonio Paxil Lawsuit Attorneys will offer you all the professional support and legal counsel you will need in filing your Paxil Side Effects Lawsuit. Call our San Antonio Paxil Lawsuit Attorney today!
