Since 2005 there have been a number of studies which concluded that Paxil increases the risk of certain birth defects. What follows is a concise summary of some of the most significant publications. A complete reference list is available form our office by request.
A large case-control study performed within the Quebec Pregnancy Registry specifically designed to study the effect of paroxetine use during the first trimester of pregnancy found that daily doses above 25 mg on average in the first trimester of gestation were associated with an increased risk (aOR 2.23, 95%CI 1.19-4.17) of major malformations and also increased the risk of having an infant born with major cardiac malformations (aOR 3.07, 95%CI 1.00-9.42). [Bérard et al., BDRB 2007]
In another study performed in the United States using the National Birth Defects Prevention Study (NBDPS) cohort, paroxetine was found to be associated with and increased risks for right ventricular outflow tract obstruction defects (aOR 2.5, 95%CI 1.0-6.0). (Alwan et al. NEJM 2007)
A Slone Epidemiology Center Birth Defects Study showed that the use of paroxetine during the first trimester of pregnancy was associated with an increased risk of right ventricular outflow tract obstruction defects (OR 3.3; 95%CI 1.3-8.8). (Louik et al. NEJM 2007)
Using the Swedish Medical Birth Registry, a study authored by Källén reported an increased risk of cardiovascular defects associated with paroxetine use during the first trimester of gestation, 2.22 (95%CI 1.39-3.55).
In a study performed within a population of women calling a teratology information service in Europe, paroxetine exposure during pregnancy a tripling the risk of cardiac malformations in newborns was reported.(OR: 3.46; 95%CI 1.06-11.24). (Diav-Citrin et al. Reprod Toxicol 2005)
A meta-analysis performed by GSK itself for the Dutch Medicines Evaluation Board (2007) reported that paroxetine use during the first trimester of pregnancy increased the risk of cardiac malformations (OR: 1.55, 95%CI 1.18-2.04).
This month in an update to his earlier study, Källén concluded that "[a]n association between use of paroxetine and congenital heart defects was verified and a similar effect on hypospadias was seen."
There is simply no doubt that Paxil is a teratogen that causes significant congenital heart deformities.
If you suspect that you or loved one has been injured or a loved one killed in by exposure to paxil, McIntyre Law, P.C. has the experience and knowledge needed to successfully handle your Paxil Birth Defect Case. Contact us immediately and we will discuss the situation with you and come up with a plan of action to help you get compensation for you or your loved one’s injuries or a loved one’s wrongful death. Visit www.mcintyrelaw.com or call toll free 1-866-917-5200 to discuss your case and find out the best course of action to ensure that you get the compensation you deserve.