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Paxil Birth Defects

Paxil (paroxetine HCl), manufactured by GlaxoSmithKline, belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs), which first hit the market in 1988 and are widely used today to treat depression, anxiety and other mood and behavioral disorders in adults as well as children.

It has been found that mothers who take Paxil have a higher risk of having a child with a birth defect. It has also been found that women who take Paxil late in their pregnancy also have a 40% increased risk of premature birth. In September of 2005 there was a change made to the Pregnancy/PRECAUTIONS section of the prescribing info for Paxil and Paxil CR. These changes came as the result of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants. Other birth defects found in the children of women taking Paxil are; abnormally shaped skull (due to sutures-skull bones prematurely closing), cleft palate, heart defects (suck as holes in the walls of the chambers of the heart), abdominal wall defects, club foot, anal atresia (partial or complete closure of the anus, PPHN (persistant pulmonary hypertension), lung problems, and brain and spinal cord defects.

A Public Health Advisory focused on newborn babies with PPHN was put out by the FDA on July 19, 2006. The Advisory stated that PPHN was six times more common in babies whose mothers took an antidepressant drug that acts as an SSRI after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. PPHN is a serious and life-threatening lung condition that occurs soon after birth of the newborn.

Many women were not made aware of the fact that taking the drug Paxil during pregnancy could potentially increase the risk of having a child with a birth defect. Many women have actually found that, due to the addictive nature of Paxil, even if they want to try and stop taking it before they become pregnant it is a very difficult undertaking. Because of this they are now suffering the consequences of their doctors and the makers of Paxil keeping them in the dark about all of this information.
 

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