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FDA Warns Doctors to not Prescribe Pixil to Pregnant Women

December 8th 2005

FDA Warns Doctors to not Prescribe Pixil to Pregnant Women

Heart Chambers

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. 

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By Dan Wilson
Best Syndication Staff Writer

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Copyright 2005 Best Syndication                                            Last Updated Saturday, July 10, 2010 09:40 PM