Understanding Paxil Birth Defects

In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its
website regarding pregnant women taking antidepressants. In this announcement,
GSK noted that it was revising its pregnancy precaution category from C to D.
This revision was based on recent studies that indicated positive evidence of
human fetal risk. In addition, GSK was placing this information in the WARNINGS
section of the Paxil label.
The FDA then advised pregnant women to switch from Paxil to another SSRI
drug, such as Prozac or Zoloft. This warning was based on the results of an
analysis of Sweden’s birth registry that showed women who took Paxil were 1.5 to
2 times more likely to give birth to a baby with heart defects than women who
took other selective serotonin reuptake inhibitors (SSRIs) or no antidepressant
at all.
Studies also showed that complications were reported for babies born to
mothers who had taken antidepressants such as Paxil in the third month of
pregnancy. Such complications included breathing difficulties, turning blue,
seizures, changing body temperature, feeding problems, vomiting, low blood
sugar, stiffness, tremor, irritability or constant crying. In other words, just
like adults, newborn babies of mothers who have taken Paxil while pregnant,
experience similar withdrawal symptoms. Because of this, tube feeding, help with
breathing and longer hospitalization may be needed. Premature births in pregnant
women exposed to SSRIs such as Paxil have also been reported.
Based on such reports obstetricians went so far as to recommend that
women avoid Paxil and reconsider using any SSRI antidepressant during pregnancy.
Still, other physicians maintain that the benefits of mothers getting treatment
for their depression outweigh the risks to the fetus.
The most common birth defects caused by antidepressants have been found
to be holes or other malformations in the chambers of the heart. Often the

defects heal on their own, but more severe cases need surgical procedures. GSK
is investigating how Paxil could be causing such defects.
In addition, antidepressant drugs are known to imbalance blood sugar
metabolism thereby worsening gestational diabetes. However, it is doubtful that
this is explained to expectant mothers who are given such drugs.
Medical professionals in women’s mental health point out that it is
important to aptly gauge the timing of medications prescribed for women who are
pregnant. Paxil is currently one of the most popular antidepressants in the
world, and roughly 25 percent of its users are women of childbearing age —
between 18 and 45.