Paxil Birth Defects

Birth Defects Associated with Use of Paxil During Pregnancy.

A recently published study in the New England Journal of Medicine showed that babies born to mothers who took Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac, Paxil, and Zoloft, during the second half of pregnancy had a significantly increased risk of being born with a birth defect consisting of Persistent Pulmonary Hypertension or PPHN. Persistent Pulmonary Hypertension or PPHN is a rare and serious respiratory disorder that causes the newborn to not properly adapt to breathing in the outside world and the newborn is thereby unable to receive enough oxygen. Ten to twenty percent of all babies with Persistent Pulmonary Hypertension or PPHN do not survive. Data from this study suggest that the ingestion of an SSRI during the last trimester of pregnancy may increase the risk of Persistent Pulmonary Hypertension or PPHN by as much as six times the normal risk. Babies exposed to an SSRI during the last trimester develop Persistent Pulmonary Hypertension or PPHN at a rate of 6 to 12 cases out of 1000 babies, as compared to 1 to 2 newborns with Persistent Pulmonary Hypertension or PPHN on average born to mothers not taking SSRIs during the same period.

The U.S. Food and Drug Administration or FDA issued a Public Health Advisory on December 8, 2005 in which it disclosed the results of two studies that examined the effects of Paxil (paroxetine) when used by pregnant women during the first trimester of pregnancy. Both these studies concluded that women who used Paxil during the first trimester (three months) of pregnancy had a greater risk of delivering babies with a cardiac defect. The common heart defects identified in the studies were atrial and ventricular septal defects. These conditions involve the wall between the right and left sides of the baby's heart not being completely developed. The Food and Drug Administration or FDA required GlaxoSmithKline, the manufacturer of Paxil, to change the pregnancy warning on Paxil from C category to D category, which means that studies in pregnant women have demonstrated a risk of birth defects to the fetus.

On April 7, 2006 the British Broadcasting Corporation (BBC) reported that a Canadian Study from the University of Ottawa of almost 5,000 mothers, found that those who used an SSRI were more likely to deliver a baby that was premature and of low birth weight. In July 2006, the Food and Drug Administration or FDA instructed the drug companies to revise the labels on SSRIs to include information about the life-threatening birth defect of Persistent Pulmonary Hypertension or PPHN. The FDA also issued an alert.

If you are taking an SSRI and are pregnant or are planning to become pregnant, please consult your physician immediately. If you or someone you know was taking an SSRI such as Prozac, Paxil, Zoloft or another anti-depressant and gave birth to a baby who suffered from a birth defect in the form of respiratory distress or a respiratory disorder, you owe it to yourself to speak to an experienced drug and pharmaceutical attorney to see if you may have a case and to discuss the possibility of bringing a lawsuit on behalf of the child to recover for the child's damages and injuries or, in the case of death, a wrongful death lawsuit to arising out of your loss. The attorney will be able to ascertain if you have an SSRI birth defect claim for which a lawsuit can be pursued and whether the case and lawsuit can be brought to a successful settlement, verdict, award or other recovery. The experienced lawyer will also be able to advise you on any deadlines for bringing your legal claim for damages arising out of SSRI birth defects. Please contact the law firm of Ury & Moskow to discuss your lawsuit with an experienced drug or pharmaceutical lawyer in our Drug Litigation Department.