Experts Say Birth Defect Risks Outweigh Benefits of SSRIs

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"Recent data suggest that the PPHN syndrome may occur as often as 2-6 cases per 1000 live births. PPHN is a frequent complicating factor in the term or near-term newborn with parenchymal lung disease, such as MAS (meconium aspiration syndrome) or pneumonia. An increased incidence of PPHN is reported for mothers who use selective serotonin reuptake inhibitors (SSRI's) during the last half of their pregnancies."

Dr Steinhorn explains that, during fetal life, pulmonary blood flow is low, with less than 10% of the combined cardiac output directed to the lungs. In fetal life, numerous factors, including hypoxia, maintain high pulmonary vascular resistance (PVR) and after birth, PVR decreases and pulmonary blood flow increases dramatically as the lungs assume the function of gas exchange, he says.

However, in some newborns, Dr Steinborn notes, the normal decrease in pulmonary vascular tone does not occur, and the result is PPHN. "This syndrome causes substantial morbidity and mortality in otherwise healthy, term newborns," he states.

PPHN is the failure of the normal circulatory transition that occurs after birth, and mechanical ventilation is usually needed to maintain adequate oxygenation. Because of their lability and ability to fight the ventilator, newborns with PPHN nearly always require sedation and paralysis is sometimes required in newborns whose condition remains unstable despite adequate sedation, Dr Steinborn says.

According to Michael Baum, a pharmaceutical drug product liability attorney and senior partner of Baum Hedlund law firm, who has been handling SSRI cases for 17 years against defendants such as, Glaxo, Pfizer and Eli Lilly in cases involving antidepressant-induced suicide, birth defects and various other injuries, the increased risk of lower fetal age and pre-term birth is likely linked to the mechanism causing higher rates of fetal heart and lung defects amongst babies whose mothers took SSRI's during pregnancy.

It is well known that SSRIs cross the placental barrier, he says, leading to exposure of the developing fetus to the SSRI itself or exposure to excess serotonin caused by the SSRI's during fetal organ formation, which then leads to cellular and organic malformation.

"While the administration of the SSRI is supposedly intended to "correct" a chemical imbalance in the depressed pregnant mother," Mr Baum explains, "its crossing the placental barrier may itself cause a chemical imbalance for a developing fetus--the presence of the SSRI may interfere with the proper balance of serotonin and serotonin re-uptake needed for normal cellular development."

"This link should have been analyzed and placed on SSRI warning labels long before pregnant women were advised to take SSRIs--now these children and their families are dealing with the tragic aftermath that could have and should have been avoided," he says.

Experts say the benefit of prescribing any drug must be weighed against its risks. According to Harvard-trained psychiatrist Dr Stefan Kruszewski, "This is never more important than when two lives are at stake as with a pregnant mom and her unborn child."

He notes that the serious risks for moms taking SSRI's may include an inability to stop taking the drug, akathisia-induced suicidality and rapid mood swings. "For the newborn," he says, "the overwhelming concern is the risk of major congenital malformations that can require life-long medical care for the child."

Dr Grace Jackson, a recognized authority on psychotropic drugs, also warns that women often find they can never return to living without the drugs not because they develop a "craving," she says, but because the withdrawal effects they experience are intolerable and are misinterpreted by physicians as "proof" of depressive relapse for which "lifelong therapy" is mandated.

One of the world's best-known experts on SSRI's, Dr Peter Breggin, says, "the worst hazards of depression in pregnancy are those of suicidality and, very rarely, infanticide."

However, he points out that SSRI's are implicated in increasing the risks of both suicide and violence and that the newest FDA labels specifically warn about SSRI-induced suicidality in young adults, the age group most likely to become pregnant. "Now we know," he says, "that the SSRI's not only threaten to cause the death of the mother through suicide but also the death of the child through lethal birth defects."

The drug makers have known for years that SSRI's increase the risk of suicide. Dr Arif Khan conducted an analysis of clinical trial data for SSRI's approved by the FDA between 1985 and 2000 and reported a finding of a higher rate of completed suicides during the trials, in Clinical Psychiatric News, August 2002.

When compared to the rate of 11 per 100,000 suicides for the general population, Dr Khan found there were 718 completed suicides per 100,000 in the clinical trials, and rates were higher among patients receiving SSRI's than with patients taking a placebo. These findings were particularly surprising, Dr Khan said, because most clinical trials try to exclude patients who are actively suicidal.

On the benefits side of the equation, a review of 38 studies on SSRI's including Zoloft, Prozac, Paxil, Serzone, Celexa and Effexor, conducted during 1987-1999, showed an average 10-point improvement in mood for patients who took the drugs, and an 8-point improvement in patients on a placebo (Kirsch, Moore, Scoboria & Nicholls, 2002).

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