Paroxetine (Paxil or Paxil CR) can more than triple major cardiac
birth defects
http://www.healthsentinel.com/org_news.php?id=115&title=Paroxetine+
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Roman Bystrianyk, "Paroxetine (Paxil or Paxil CR) can more than
triple major cardiac birth defects", Health Sentinel, December 29,
2006,
Paroxetine, known by the brand names Paxil or Paxil CR in the United
States, is a selective serotonin reuptake inhibitor, or SSRI,
antidepressant. Paroxetine was introduced in 1992 by GlaxoSmithKline
and has become one of the most prescribed antidepressants on the
market. In fact, paroxetine is the third most prescribed
antidepressant in the United States and the most prescribed
antidepressant in Canada.
In late 2005 the FDA and Health Canada issued two warnings regarding
first trimester exposure to paroxetine and the increased risk of
cardiac malformation in newborns. A study in Reproductive Toxicology
published in April 2006 showed a two-fold increased risk of cardiac
malformations in women taken paroxetine during the first trimester.
This conclusion agreed with earlier unpublished reports performed in
2005 by GlaxoSmithKline also showing a doubled risk of cardiac
malformations.
A new study published in Birth Defects Research Part B: Developmental
and Reproductive Toxicology, examined in greater detail the
association between exclusive first trimester exposure to paroxetine
and the occurrence of any major congenital malformation, and more
specifically, major cardiac malformations. The authors used a number
of medical databases examining all pregnancies that occurred in
Quebec between January 1997 and July 2003.
Adjusting for a number of variables, as well as for second and third
trimester exposure to antidepressants, paroxetine exposure during the
first trimester or pregnancy compared with the use of other SSRI and
non-SSRI antidepressants did not significantly raise the risk of
congenital malformations. Although this showed no difference in birth
defects it must be taken with the information found in a recent
population-based cohort study that found the use of any SSRI
antidepressant in the first trimester of pregnancy resulted in a 40%
increase in birth defects and more specifically a 60% increased risk
in cardiac abnormalities.
When the study authors examined a dose of paroxetine of greater than
25 mg (milligrams) they found a major increase in general birth and
specifically cardiac defects. "Paroxetine was significantly
associated with a two-fold increase in the risk of major congenital
anomalies, and more specifically with a three-fold increase in the
risk of major cardiac anomalies."
Again, this study compared paroxetine with other antidepressant drugs
so the 200% increase in major congenital birth defects and 300%
increase in cardiac malformations could reasonably be 240% and 360%
if compared to those not taking any antidepressant medication.
The authors conclude, "using a population based pregnancy registry,
our study showed no increased risk of major congenital malformations,
specifically major cardiac malformations, associated with the first
trimester exposure to paroxetine. For the first time, however, a dose-
response relationship between average daily dose of paroxetine
utilization during the first trimester of pregnancy and occurrence of
major congenital malformations, and major cardiac malformations, was
found. Pregnant users of more than 25 mg/day of paroxetine were at a
two-fold increased risk of having an infant with a major
malformation, and at a three-fold increased risk of having an infant
with a major cardiac malformation."
SOURCE: Birth Defects Research Part B: Developmental and Reproductive
Toxicology, December 2006
.