Paxil®
Paxil (paroxetine) is one of a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These drugs increase the activity of an important brain chemical called serotonin. Paxil was first approved in the United States on December 29, 1992, for the treatment of depression. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride. It is manufactured by GlaxoSmithKline, a large pharmaceutical company with reported earnings of $43.7 billion. For more information on Paxil birth defects, click here.
Paxil® and Birth Defects
The Food and Drug Administration (FDA) has issued multiple Public Health Advisories regarding the risk of congenital malformations in babies born to mothers who take Paxil (and other similar SSRIs drugs) during pregnancy. In particular, the increased risk is associated with persistent pulmonary hypertension of a newborn(PPHN), cardiac malformations such as atrial and ventricular septal defects (holes in the walls of the chambers of the heart). At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D (which indicates that "there is positive evidence of fetal risk") and added new data and recommendations to the Warnings section of paroxetine's prescribing information.
In a study using Swedish national registry data, women who received paroxetine in early pregnancy had approximately a 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants). In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common types of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only.
Another study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension of a newborn (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth and often need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another and this risk has not been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.
Sean Patrick Tracey is the first attorney to obtain a trial date for a Paxil birth defect case. Our client's story was publicized by the Houston Press on September 14, 2006.
Consult a Paxil Litigation Attorney
It is crucial that you consult an attorney if you are considering pursuing a Paxil lawsuit. With our extensive experience and resources in pharmaceutical litigation and, our dedication to our clients, we are able to effectively represent our clients’ interests and provide the highest quality legal representation possible.
Contact Tracey Law Firm today to discuss your situation with an experienced Paxil litigation lawyer.