Paxil (paroxetine)
may cause defects
in newborn babies |
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Since September 2005, information has been
emerging that Paxil may cause birth defects
including cardiac (heart), pulmonary (lung),
craniosynostosis (abnormally shaped skull), and
infant omphalocele (abdominal wall defects).
Our law firms represent families whose children were born with birth defects to
mothers who took Paxil during pregnancy. If you took Paxil during pregnancy and
your child suffered a birth defect, we will investigate your case at no charge to you.
Anyone in need of a Paxil lawyer or anyone interested in
filing a Paxil birth defect lawsuit, should contact us at: |
Call 800-324-3036 to have your case
evaluated by an attorney
Heart Birth Defects:
The FDA issued a Public Health Advisory for Paxil on December 8, 2005,
based on U.S. and Swedish studies showing that exposure to Paxil in the first
trimester of pregnancy may be associated with an increased risk of heart birth
defects. Most of the cardiac defects observed in these studies were
atrial or ventricular septal defects, conditions in which the wall between
the right and left sides of the heart is not completely developed. In general,
septal defects are one of the most common type of congenital malformations.
Lung Birth Defects:
On July 19, 2006, the FDA issued another Public
Health Advisory for Paxil based on a study that suggests
there may be additional risks from using SSRI
medications, including Paxil, during pregnancy. This
study focused on newborn babies with persistent
pulmonary hypertension (PPHN), which is a serious
and life-threatening lung condition that occurs soon
after birth of the newborn. Babies with PPHN have
high pressure in their lung blood vessels and are not
able to get enough oxygen into their bloodstream.
About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly
after birth, and often they need intensive medical care. In this study,
PPHN was six times more common in babies whose mothers took an SSRI
antidepressant after the 20th week of the pregnancy compared to babies
whose mothers did not take an antidepressant. |
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Abdominal Birth Defects:
GSK (GlaxoSmithKline), maker of Paxil, sent a letter to doctors and healthcare
professionals in September 2005 advising them of a Paxil label
change—that women who took an SSRI-antidepressant were more likely to
have an infant with omphalocele (an abnormality in newborns in which the
infant’s intestine or other abdominal organs protrude from the navel) than
those who were not exposed—according to data obtained from the
National Birth Defects Prevention Study of Infants. The strongest effect
was reported to be with Paxil (paroxetine), which accounted for 36% of all
SSRI exposures.
Cranial Birth Defects:
GSK, in their September 2005 “Dear Doctor” letter, included that the
authors of the above study also found an association of exposure to any
SSRI-antidepressant with giving birth to an infant with craniosynostosis—
a congenital defect, present at birth, in which the connections between
sutures (skull bones) prematurely close during the first year of life, which
causes an abnormally shaped skull.
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