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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2007 – Paxil, SSRIs associated with risk for fetal malformations

Posted in Paxil Birth Defects, SSRI Birth Defects

Paroxetine (marketed under the brand name “Paxil”) is a selective serotonin reuptake inhibitor (SSRI) commonly prescribed to treat women suffering from depression during pregnancy.  Many warnings have been issued against Paxil use during pregnancy as a result of conflicting findings associated with first trimester usage of paroxetine.  These findings focus on the teratogenic risks of using paroxetine; teratogenic risk refers to abnormal development of the fetus.  Despite the risks posed when Paxil or other SSRIs are used during pregnancy, they have continued being used due to potential harmful effects of untreated depression.

Several studies have investigated whether or not SSRIs, such as paroxetine, are associated with an increased risk of teratogenic malformations.  One such study was conducted by Berard et al. titled “First trimester exposure to paroxetine and risk of cardiac malformations in infants: the importance of dosage.”  This study was published in the Journal of Birth Defects Research: Part B, Developmental and Reproductive Toxicology.  The authors state that “This study attempts to quantify the association between first trimester exposure to paroxetine and congenital malformations, adjusting for possible confounders, and to quantify the dose-response relationship between paroxetine use and cardiac defects.”

Data were collected from the Medication and Pregnancy registry and analysis was only performed on data from women between 15-45 years old and used only one type of antidepressant during the first trimester.  Additionally, cases were defined as having any major malformation or any cardiac malformation diagnosed in the first year of life; controls were defined as no major or minor malformations.

The dataset included 1,403 women.  In these cases 101 infants were identified as suffering from major congenital malformations, there were 24 cases of cardiac malformations.  They key finding in this study was the effect of dosage.  The authors state “When considering the dose, however, a dose-response relationship was observed, thus women exposed to >25mg/day of paroxetine during the first trimester of pregnancy were at increased risk of having an infant with major congenital malformations (adjusted OR=2.23, 95% CI = 1.19, 4.17), or major cardiac malformations (adjusted OR =3.07, 95% CI=1.00, 9.42).”

Thus, the authors concluded that congenital exposure to more than 25 mg/day of paroxetine is associated with an increased likelihood of major congenital malformations and major cardiac malformations.

If you or a loved one used SSRIs during pregnancy and your child was born with a birth defect, you may be entitled to significant financial compensation for the injuries caused to your family by the negligence of pharmaceutical manufacturers.  For more information on SSRI birth defect lawsuits, please do not hesitate to call out team of Paxil® birth defects lawyers and SSRI birth defects lawyers at the information provided below.  We are here to help you win the justice you and your family deserve.  Call today and see what we can offer.

(855) 452-5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.