June 13th, 2007

"Paxil During Pregnancy Leads to Serious Birth Defect"

Use of the anti-depressant drug Paxil during pregnancy has been linked to a very serious birth defect in infants - PPHN, or persistent pulmonary hypertension of the newborn. Paxil (paroxetine HCl) is one of a group of drugs called SSRIs (selective serotonin reuptake inhibitors) that have been found to increase the risk of birth defects such as PPHN when taken by pregnant women.

Increased Risk of PPHN after SSRI Use

A February 2006 study published in The New England Journal of Medicine showed that the babies of the women who were taking an SSRI after the 20th week of gestation were six times more likely to have PPHN than babies of mothers who weren't taking any medication. The U.S. Food and Drug Administration (FDA) then issued an alert to doctors and healthcare providers warning them to consider alternatives to SSRIs for pregnant women. GlaxoSmithKline, the maker of Paxil, strengthened the label warning on Paxil to Category D - medications that may have harmful effects on fetuses.

PPHN Symptoms

PPHN can be life-threatening to a baby. Its symptoms include:

• Respiratory distress, including signs such as grunting, flaring nostrils
• Rapid heart rate
• Rapid breathing
• Cyanosis (a bluish tinge to the baby's skin), even while the baby is getting extra oxygen to breathe
• A baby with PPHN may also have low oxygen levels in the blood while receiving 100% oxygen.

Paxil is prescribed for depression, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder, and obsessive compulsive disorder. A controlled-release version of Paxil called Paxil CR is also prescribed for premenstrual dysphoric disorder. Millions of patients in the U.S. have been treated with Paxil or other SSRIs, and the link between SSRIs and birth defects is still under investigation.

Taking Paxil Before the Pregnancy Is Known

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 82% of American women in their childbearing years use some type of medication, and many women are taking medication before they discover that they are pregnant. (About 50% of all pregnancies in the U.S. are unplanned.) Most birth defects arise during the first trimester of pregnancy.

In addition, for many pregnant women, discontinuing an anti-depressant is not an easy option. It is estimated that up to 20% of pregnant women suffer from clinical depression, and symptoms addressed by an anti-depressant may be so severe that continued use of the drug is chosen, despite its risks to the fetus.

(Source: fda.gov; medscape.com)

Does your infant have PPHN? Contact a compassionate and qualified attorney to protect your legal rights.