Birth Defect Study
Paxil Birth Defects (Side Effect)
Congenital Heart Defects
The Food and Drug Administration (FDA), through a public health advisory, has concluded that exposure to paroxetine in the first three months of pregnancy may increase the risk for congenital malformations, specifically cardiac malformations -- like Septal Defects. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.
The Paxil side effect findings are based on two separate studies - conducted with the Swedish national registry and a United States insurance claims database - indicating that infants born to mothers who used paroxetine during the first trimester have at a minimum risk increase of 1.5 fold.
Related: FDA Pregnancy warning for Paxil increased from C to D.
The FDA is awaiting the final results of these studies. Until the final results are provided, the FDA is recommending the following:
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.
Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
persistent pulmonary hypertension (PPHN)
A study published the The New England Journal of Medicine (Christina Chambers) illustrates the possible dangers of selective serotonin reuptake inhibitors (SSRI) medications during pregnancy.
Newborn babies that develop persistent pulmonary hypertension (PPHN) , a life-threatening condition of the lungs, were the focus of the birth defect study. The rate of PPHN in babies whose mother used an SSRI antidepressant, like Paxil, after the 20th week of pregnancy was six fold over those babies whose mothers did not take an antidepressant.
Since the study was too small to make a general finding, the FDA has issued the following public health advisory:
The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. In the meantime, the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. Prescribing information will be updated with information from additional studies when this information becomes available.
National Birth Defects Prevention Study (NBDPS)
The National Birth Defects Prevention Study examined information from 9,622 infants with major birth defects and 4,092 infants without major birth defects. All infants within the study were born between 1997 and 2002.
The NBDPS found an association between SSRI use and three specific birth defects: a defect of the brain, one type of abnormal skull development and a gastrointestinal abnormality.
Specifically, the study showed that those mothers that used an SSRI, like Paxil, had a 2.4 percent higher risk of having a baby with anencephaly, or no brain. Further, the study found increased association with craniosynostosis, when a baby skull forms too early so the brain is not able to grow properly, as well as omphalocele, when organs extend outside the body.
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