By Chris Lane
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The most commonly reported malformations have been atrial and ventricular septal defects. These are holes in the membrane that separates the chambers of the heart, and often can be surgically repaired.
Vickery and Waldner are in the preliminary stages of filing several lawsuits against GlaxoSmithKline. They are selecting the most extreme and unique cases, all of which required multiple surgeries. In one instance, a baby was born without heart chambers. In another, the aorta and pulmonary artery were conjoined as one vessel.
Vickery points to revelations that GlaxoSmithKline selectively used clinical trial data to play down the risks of violent behavior in Paxil users. He predicts similar information will emerge regarding the dangers to fetuses.
"We gained access to a lot of GlaxoSmithKline documents that are not in the public domain," says Vickery, whose firm is devoted entirely to antidepressant cases. "We're not some wild-eyed crazy lawyers blowing smoke."
Vickery says the first claim linking Paxil with heart defects in fetuses appeared in a 1998 report filed in the FDA's "adverse effects" database.
In 2003 GlaxoSmithKline began the first major study on the subject, performing a retrospective analysis of pregnant women, dating back to 1995, who had taken antidepressants in the first trimester and had given birth to children with major congenital malformations. The analysis showed a more than twofold increase in women taking Paxil compared to other antidepressants.
At about the same time researchers analyzed data from Sweden's birth registry, which collects information on pregnant women and offspring, and found birth defects were twice as common among Paxil users.
Based on these studies, the FDA changed Paxil's labeling.
Meanwhile, new reports continued to surface showing a wider array of health risks for pregnant women taking Paxil and similar antidepressants.
A 2005 study published in The Teratology Society reported women who took Paxil were more likely to have infants with birth defects such as omphalocele, in which the intestines or other abdominal organs protrude from the navel, and craniosynostosis, the early closing of one or more of the sutures of an infant's head, resulting in malformation of the skull as well as mental retardation and blindness.
A February 2006 study published in The Archives of Pediatrics & Adolescent Medicine examined 60 newborns exposed in utero to SSRIs. Of these, 18 showed mild to severe signs of "neonatal abstinence syndrome," or withdrawal from the drugs at birth. Symptoms included tremors, high-pitched crying and feeding difficulties.
One week later a study published in The New England Journal of Medicine showed taking antidepressants such as Paxil after 20 weeks of pregnancy greatly increases the risk of having a baby born with persistent pulmonary hypertension. As much as 20 percent of babies born with the disease die soon after birth, while others will have developmental delays, hearing loss and brain abnormalities.
And a report last month in the Archives of General Psychiatry found that babies born to women who took SSRIs during pregnancy face an increased risk of having a low birth weight and developing respiratory distress.
These studies and several others still awaiting publication would seem to offer ample proof that SSRIs and pregnancy should not mix. But many doctors remain unconvinced.
Chambers led a study ten years ago showing neonatal problems in infants born to mothers using SSRIS but says the risks were not statistically significant compared to the general population. Chambers and many others say the sample sizes in most studies have been too small to be considered definitive.
They face the difficult task of proving the antidepressants caused the deformations in much the same way attorneys had to show the drugs and not the depression were causing violent behavior.
Renegar, the GlaxoSmithKline spokeswoman, is quick to point out that congenital heart defects affect 3 percent of the general population and often have no discernible cause.
Kwok believes there will be strength in numbers.
"The drug company's not going to be able to deny causation," he says, "when I have 100 babies lined up with the same problem."
So what's a depressed woman in her childbearing years to do?
Doctors remain divided on this question, since depression during pregnancy carries its own risks. Several studies have linked the illness to higher rates of miscarriage, stillbirths, premature deliveries and developmental delays.
"Someone who is severely depressed, who is not getting out of bed, not eating, not tending to prenatal care -- I'm going to medicate her," says Dr. Margaret Spinelli, director of the Maternal Mental Health Program at the New York State Psychiatric Institute.
But Spinelli and others say they may be more inclined to prescribe tricyclics, a previous generation of antidepressants developed in the '70s not found to cause birth defects.
Psychiatrist and author Peter Breggin, a longtime critic of SSRIs, says it's hard to get unbiased information about treatment options for depressed pregnant women because of what he perceives as the incestuous relationship between drug companies and the FDA.