Posted On: May 10, 2010 by Carey, Danis & Lowe, L.L.C.

Paxil, Birth Defects and You

According to recent studies, women who take Paxil during their first trimester are at an increased risk of their child developing birth defects. Two independent studies of women taking Paxil during the first three months of pregnancy showed those women were anywhere from one-and-a-half to two times as likely to have a baby with heart defects than either women in general or women on other antidepressants. Further studies showed a strong link between Paxil and persistent pumonary hypertension (PPHN), a rare but dangerous birth defect that can lead to organ failure and death.

The FDA issued an alert in 2005, warning consumers of the increased risk of Paxil for birth defects in the first trimester. The majority of the abnormalities were septal defects, which are holes in the walls of heart chambers which interfere with the healthy flow of blood. Such defects do range in severity from minor, self-correcting abnormalities to those which are quite severe, requiring surgical intervention.

The link to PPHN first was published in the New England Journal of Medicine a few months after FDA issued the alert on Paxil and its potential for defects. This study showed evidence that women using Paxil after the 20th week of pregnancy were six times more likely to have a child with PPHN than women who used no antidepressants.

PPHN is a serious condition that can prove fatal even with prompt diagnosis and swift intervention. Permanent damage to speech, hearing and the brain are often common even in those who survive.

The FDA has asked the manufacturer of paxil to change the drug's pregnancy category from C to D, which indicates that studies show there is a significant risk to the fetus.

source: http://www.adrugrecall.com/paxil/birth-defect.html