Monday, June 06, 2011

Georgia: Birth Defect Link to Antidepressants?

Several studies from 2005 onward suggest that antidepressant drugs like Zoloft, Paxil, Celexa, Effexor, Lexapro, Pristiq and Prozac may increase the risk of cardiac birth defects. Mothers who have taken antidepressant drugs during pregnancy have reported these devastating medical problems:Cardiac defect, PPHN, Neural tube defects, craniosynostosis, abdominal wall defects, club foot, and cleft lip and cleft palate.
Taking antidepressants such as Zoloft, in the early stages of pregnancy may alter development of the fetus, a new study indicates. 
Many woman take antidepressants during pregnancy with no effect, but Zoloft, among others, may double the risk of a heart defect if taken early in the pregnancy, finds this study out of Aarhus University, Denmark, which looked at nearly half a million children born there between 1996 and 2003.
For the purposes of this study, early pregnancy was defined as 28 days before conception to 112 days after conception. The heart defect was very specific. It is in a piece of tissue that separates areas of the heart.
Zoloft increased the risk, as did Prozac and Celexa.  So did using more than one antidepressant at a time reports Reuters. Zoloft more than tripled the risk, while Celexa more than doubled the risk.
Translating that into births – for every 250 women who do not take antidepressants during pregnancy, expect one infant to be born with the defect. That number increases to two infants for every SSRI taken, and four infants for mothers taking more than one.
SSRIs or selective serotonin reuptake inhibitors taken during pregnancy have also been connected with birth defects and heart defects in other studies.

From the FDA site in 2006:

A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy

From a 2007 study: 
One study of nearly 10,000 infants born with birth defects and nearly 6,000 healthy infants found that women who took sertraline (Zoloft) in the first few months of pregnancy had twice the risk of having a baby born with a heart defect, while those on paroxetine (Paxil) had more than three times the risk. Paxil also increased the risk of a rare hernia called an omphalocele. But this doesn’t mean antidepressants are unsafe: The heart defects seen in the study normally occur in 5 out of 10,000 babies, so a doubling of the risk means they occur in 10 in 10,000 and a tripling in 15 in 10,000—thus, a baby’s risk is still far less than 1 percent.
Talk to us if you’re worried that your child may have been harmed while you were taking any of these medications. We’re not just lawyers, we are parents – fathers, uncles, cousins. The call is free and confidential.