Birth Defect Study
Paxil - During Pregnancy Warning
GlaxoSmithKline (GSK), at the request of the FDA, has changed the pregnancy category from C to D for Paxil -- a stronger warning. The change was requested based on two seperate studies showing a possible relationship between taking Paxil and a risk to the fetus.
Read about more Paxil Birth Defects and Paxil Side Effects
Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D
There is positive evidence of human fetal risk based on adverse
reaction data from investigational or marketing experience or studies
in humans, but potential benefits may warrant use of the drug in
pregnant women despite potential risks.
GSK Medical Release
GSK recently conducted a retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. Preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants. The types of congenital malformations, which were most commonly cardiovascular, were reflective of those seen in the general population. The most common cardiovascular malformations observed in the study were ventricular septal defects.
[Read Entire GSK (Paxil) Medical Update]
Paxil Birth Defects
Paxil Medical and Legal Assistance
If you believe that you or a love one has suffered a personal injury as a result of taking the drug Paxil, PaxilNews.com has the contacts to assist you.
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