If you or someone you know took Paxil® and gave birth to a baby who had a birth defect, please contact us using the following simple contact form or click HERE to submit a more detailed inquiry to us.

Name: Email: Phone: Date Taken:  Also, please consider filling out our case evaluation form

FDA 12/2005 Public Alert – Paxil
In December, 2005, the U.S. Food and Drug Administration ("FDA") issued a Public Alert announcing that the preliminary results from two separate studies indicate that the use of Paxil® (paroxetine) during pregnancy increases the risk that a baby will be born with a congenital malformation – particularly a cardiovascular malformation. The studies were retrospective reviews of information extracted from medical records. In one study, data was gathered from the Swedish national registry and indicated that women who took Paxil® early in pregnancy were twice as likely to give birth to babies with congenital malformations than those women who did not take Paxil® early in their pregnancies. In the second study, information was extracted from a U. S. insurance claims database. This information indicated that babies were 1.5 times more likely to be born with a congenital malformation – particularly cardiovascular malformations – if their mothers took Paxil® during the first trimester of pregnancy.

Most cardiovascular malformations that were observed in the two studies were atrial or ventricular septal defects, conditions in which an interior wall of the infant’s heart has not sufficiently developed. These defects may or may not require surgery to repair but in either case pose challenges to the newborn’s health.

Shortly after the issuance of this Public Alert, the FDA issued a Public Health Advisory notifying the public that the warnings and labeling for Paxil® would be changed to reflect the new data and risks associated with the use of Paxil®. In its Public Health Advisory, the FDA points out that the data in these two studies was limited to Paxil® use early in pregnancy and the extent of risk of Paxil® use later in pregnancy was unknown.

If you or someone you know took Paxil® and gave birth to a baby who had a birth defect, please contact us using the following simple contact form or click HERE to submit a more detailed inquiry to us.

Name: Email: Phone: Date Taken:  Also, please consider filling out our case evaluation form

SSRI Use During Pregnancy and Neonatal PPHN
A recently published study that appeared in the prestigious New England Journal of Medicine indicates that the use of certain anti-depressant medications during the latter half of pregnancy may increase the risk that the newborn will develop a serious respiratory disorder known as Persistent Pulmonary Hypertension (PPHN). The anti-depressant drugs – known as Selective Serotonin Reuptake Inhibitors (SSRIs) include the following:

• Paxil® (paroxetine)
• Prozac® (fluoxetine)
• Zoloft® (sertraline)
• Celexa® (citalopram)
• Cipralex® (escitalopram)
• Luvox® (fluvoxamine)
• Remeron® (mirtazapine)
  and Effexor® (venlafaxine).

Data from this study indicate that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) such as Paxil®, Prozac®, Zoloft® during the second half of pregnancy may increase the risk of Persistent Pulmonary Hypertension (PPHN) by as much as six times the normal risk. Historically, Persistent Pulmonary Hypertension (PPHN) occurs in 1-2 infants per 1,000 live births. However, data from this study suggest that when Selective Serotonin Reuptake Inhibitors (SSRIs) such as Paxil®, Prozac®, Zoloft® are used by a woman during the second half of her pregnancy, the rate of Persistent Pulmonary Hypertension (PPHN) increases to 5-6 cases per 1,000 live births.

Persistent Pulmonary Hypertension (PPHN) is a serious pulmonary (respiratory) disorder that can develop in newborn babies and impairs the ability to supply oxygen-rich blood to the body. When a newborn suffers from Persistent Pulmonary Hypertension (PPHN), the pulmonary arteries (blood vessels in the lungs) fail to fully open, i.e. these arteries remain constricted. Because of this, the newborn is unable to oxygenate his/her blood. As a result, the infant cannot provide an adequate supply of oxygen-rich blood to his/her tissues and organs. Without an adequate supply of oxygen-rich blood, the infant can suffer serious complications.

If you or someone you know took Paxil® and gave birth to a baby who who suffered from birth defect or a respiratory disorder, please click HERE to find out more about your or her legal rights.

Name: Email: Phone: Date Taken:  Also, please consider filling out our case evaluation form