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New Study Re-affirms Paxil Causes Birth Defects

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Washington, DCVarious Paxil defects, including those associated with newborns, have been known since September 2005. That's when studies first surfaced that suggested a link between the antidepressant and Paxil birth defects. In response the US Food and Drug Administration (FDA) mandated GlaxoSmithKline to update product labeling for birth defects, and other Paxil side effects.

Since then there have been conflicting reports, including a pair of studies published a year ago that appeared to suggest minimal risk to newborns from antidepressants consumed early in pregnancy.

NewbornHowever, a new report appears to conflict with those findings, and aligns more with original studies published in 2005. In fact, the latest study finds that pregnant women who took two types of antidepressants—one of which is Paxil—during their first trimester were 3, to 4 times more likely to give birth to a child with heart problems.

The study, published this month in the British Journal of Clinical Pharmacology, focused on babies born to 800 women who said they took either fluoxetine, or paroxetine (Paxil) during the first trimesters of their pregnancies. Comparison was then made to 1,400 expectant mothers who were not on antidepressants of any kind.

It was determined that expectant mothers who had taken Paxil in their first trimester were three times more likely to deliver a child with a heart anomaly.

It has been reported that depression is experienced by more than 10 percent of pregnant women each year. Critics of the studies vilifying antidepressants such as Paxil, including the study's own authors, make the point that antidepressants can have a significant benefit, and given the treatment options for heart defects available today, the benefits of taking Paxil, for example, may outweigh the risks to the child.

"Many heart anomalies can now be treated, so it is important to bear that in mind when making a decision about whether or not to continue with one of these drugs," said Asher Ornoy of the Israeli Teratology Information Service, who co-authored the study. "The health of the mother and the baby are both important."

However, critics of that position cite GlaxoSmithKline's own study in 2005 that revealed major Paxil birth defects. Amongst the 3,500 pregnant women who participated in the study, Paxil was linked to twice as many birth defects as other antidepressants. Most of the birth defects were heart related, and of those the most common were ventricular septal defects, or holes between the heart's two primary chambers.

Two additional studies seemed to back up Glaxo's own inquiry, based on early results (early at the time) that suggested women who took Paxil during their first trimester were up to two times as likely to have a baby born with a heart defect, as women who ingested other antidepressants or women representing the general population.

It was reported that the Paxil birth defects inherent with these two other studies were similar to the findings of Glaxo's—holes in the heart that ranged in severity from minor (and thus resolved without treatment), to far more serious complications requiring surgical intervention.

As a result, the FDA mandated a change in classification for birth defect risk from Category C (Risk of fetal harm cannot be ruled out), to Category D (Positive evidence of fetal risk).

Paxil belongs to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which affect seratonin levels in the brain. Paxil was first brought to market in 1992, and by 2006 was the 5th most-commonly prescribed antidepressant in the country with more than 19 million prescriptions.

While antidepressants remain an important medication for a wide variety of Americans, their implications for an expectant mother are varied. Given that many studies have revealed a significant chance of Paxil birth defects inherent with babies born to expectant mothers having taken Paxil in the first trimester—and the FDA's own position on the issue—it is not only important to weigh the Paxil side effects against the benefits, but also to question the safety of a medication approved for general use.

That, and the proper communication of those risks. Did you know that Paxil defects could harm your newborn? Were you told? Was the information displayed prominently enough? If not, and you delivered a child with Paxil birth defects, you should seek legal representation.


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