Paxil Birth Defects Lawsuits Growing


. By Jane Mundy

Given the facts that one in 10 women will suffer from depression during her pregnancy or the postpartum period, that the antidepressant drug Paxil sales reached $1 billion in 2007, and Paxil has been linked to birth defects, it's no wonder that Paxil birth defects lawsuits are growing.

Since the FDA issued an alert in 2005 that required GlaxoSmithKline to put a warning label on its medication, more than 600 Paxil birth defects lawsuits have been filed by attorneys nationwide. (The 2005 warning label advised doctors not to prescribe the antidepressant to any woman who planned to become pregnant or was in her first three months of pregnancy.)

These attorneys represent women who claim their babies were born with serious birth defects as a result of taking the drug during their first three months of pregnancy. Furthermore, a number of women were unaware that they were pregnant when they took Paxil. Had they only known…

Approved by the FDA in 1992, GlaxoSmithKline scientists raised concerns about birth defects linked to Paxil back in 1997. Medical studies in 2005 found that Paxil is directly related to infant heart defects.

Then in 2006, the FDA made public a case-control study that said infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) such as Paxil after the 20th week of pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy. Next up, the agency raised the pregnancy warning for Paxil from a category C to a category D, which indicates that taking Paxil during pregnancy has serious potential to damage a fetus.

Recent lawsuits about Paxil allege the drugmaker GlaxoSmithKline continued to promote Paxil while withholding evidence that it caused significant birth defects, making consumers believe that it was safe to use while pregnant. Attorneys claim this critical birth defect information was not disclosed to consumers. Even today, people are unaware that many SSRIs such as Paxil may cause birth defects.

To make matters worse, many pregnant women who are on Paxil may find themselves in a "Catch-22" situation: The Mayo Clinic has reported that taking antidepressants during pregnancy may cause health risks to a developing baby, but stopping may pose risks for the mother. A pregnant woman faces severe withdrawal symptoms if she simply stops taking Paxil. But Paxil has been linked to neonatal PPHN—life-threatening lung disorders—in newborn babies whose mothers take Paxil during pregnancy. A pregnant mother on Paxil, or any SSRIs, must consider that risks outweigh the benefits.


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