FDA Warns Doctors to
not Prescribe Pixil to Pregnant Women
December 8th
2005
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Heart Chambers |
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The FDA warned doctors to not prescribe the Antidepressant Paxil to
women in the early stages of their pregnancy. According to the Food and
Drug Administration (FDA) taking Paxil increases the chances of birth
and heart defects in newborns.
It is recommended that doctors prescribe another antidepressant during
the first three months of pregnancy. This should also be done for women
planning to become pregnant.
Some of the babies had a small hole in the wall separating the heart
chambers. There were two studies and the first showed that heart
defects occurred in 2% of the babies where the mother took Paxil in the
first 3 months of pregnancy. The rate for this defect in the general
population is 1%.
The second study compared Paxil to other antidepressants. The rate of
heart defect associated with the other antidepressants was about the
same as the general population (1%). The rate of heart defect
associated with the use of Paxil was 1.5% in that study. Although some
of the defects correct themselves, others required surgery.
Paxil is made by Glaxo SmithKline, and is used to treat depressive
illness. Clinical trials have shown that continuation treatment with
paroxetine (Paxil) in patients with moderate to moderately severe
depression is effective for at least 6 months.
Paxil was introduced in 1993 and over 100 million prescriptions have
been written in the US. Glaxo SmithKline has changed their warning
label to include the new early pregnancy warning.
By Dan Wilson
Best Syndication Staff Writer
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