Brand Names: PAXIL, PAXIL CR, Paxil Oral Suspension, Pexeva
Chemical Name: Paroxetine hydrochloride
Faults: Heart Birth Defects, Lung Birth Defects, Abdominal Birth Defects, Cranial Birth Defects
The drug “paroxetine” is manufactured, promoted, distributed, labeled and marketed by GlaxoSmithKline under the trade name Paxil, Paxil Oral Suspension, and Paxil CR. Paxil is a member of a class of drugs known as “selective serotonin reuptake inhibitors” or “SSRIs.”
Paxil was first approved for use in the United States by the FDA in 1992 for the treatment of depression in adults. The American Medical Association estimates that over 1 percent of pregnant women in the US, or more than 40,000, are taking antidepressants.
Recently, new concerns have been raised about the safety of antidepressants during pregnancy, mostly among the SSRI class of drugs. Some studies have found an increased risk of a potentially fatal breathing disorder and an increased risk of seizures and fetal death among infants born to mothers using a broad spectrum of SSRI’s.
Since September 2005 information has indicated that Paxil may cause birth defects including, heart, lung, abdominal wall, and cranial defects. According to the FDA, in a study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants.
Paxil crosses the placenta, which could have important implications for the developing fetus. Serotonin (the neurotransmitter that Paxil primarily affects) plays a roll in the fetal development of the heart.
Heart Birth Defects: The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations.
Lung Birth Defects: On July 19, 2006 the FDA issued another Public Health Advisory for Paxil based on a study that suggests there may be additional risks of SSRI medications, including Paxil, during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.
Abdominal Birth Defects: GSK – GlaxoSmithKline, maker of Paxil, sent a letter to doctors and healthcare professionals in September, 2005 advising them of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with omphalocele (an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel. The strongest effect was reported to be with Paxil, paroxetine, which accounted for 36% of all SSRI exposures.
Cranial Birth Defects: GSK – GlaxoSmithKline included in the September, 2005 “Dear Doctor” letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)