A major women’s health advocacy group issued a strong warning today against the use of Paxil by pregnant women or those who plan to become pregnant. The American College of Obstetricians and Gynecologists (ACOG) urged that paroxetine (the generic term for Paxil) be avoided during or before pregnancy because of the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.
In their announcement, the ACOG noted: “Unpublished data regarding the use of Paxil during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations.†In December of 2005, the FDA changed the drug’s classification from Category C to Category D, which means that observational or controlled studies of pregnant women have shown that consumption of the drug during pregnancy is a risk to the fetus. (A Category C classification is for drugs that have been shown to harm fetuses in animal studies but have not been adequately studied in humans.)
The ACOG also recommends that women who were exposed to Paxil in early pregnancy should be considered for fetal echocardiography, an ultrasound test that is intended to show the structure of an unborn baby’s heart in much greater detail than a routine pregnancy ultrasound.
Several Paxil birth defect lawsuits have been filed against GlaxoSmithKline, the drug’s manufacturer, on behalf of Paxil patients who have given birth to infants with serious heart defects or persistent pulmonary hypertension, a severe lung condition in which blood flow to the lungs is constricted. Paxil, or paroxetine, was first approved for use by the FDA in 1993 and has become one of the world’s most prescribed drugs.
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