Parents Enraged At Glaxo Over Paxil Birth Defects

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By Evelyn Pringle (about the author) Page 2 of 4 page(s)

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Lisa is probably right but the problem is that Glaxo did not warn doctors about the risk of heart defects until September 2005, when the company sent out a "Dear Doctor" letter saying the results of its analysis showed a higher rate of "congenital malformations associated with the use of Paxil as compared to other antidepressants" in infants born to women taking antidepressants during the first trimester of pregnancy.

For its part, since December 2005, the FDA has issued three Public Health Advisories about the risk of congenital heart defects and has upgraded Paxil's pregnancy category from C to D, which indicates that there is positive evidence of fetal risk.

The Vasquez family lawsuit alleges in part, that Glaxo was negligent in, "Failing to fully disclose the results of the testing and other information in its possession regarding the possibility that Paxil can interfere with the proper development of an unborn fetus."

The complaint specifically charges that, "GSK promoted Paxil for use with pregnant women despite the fact that GSK knew or should have known that Paxil is associated with an increased risk of congenital abnormalities."

The FDA initially approved Paxil in 1992, and due to an aggressive marketing campaign by Glaxo, it quickly became one of the most popular drugs worldwide. Paxil belongs to the class of antidepressants known as the selective serotonin reuptake inhibitors (SSRIs).

However, over the past couple of years, studies have linked Paxil to a variety of serious birth defects. In September 2005, Glaxo sent out a "Dear Doctor letter" advising healthcare professionals of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI were more likely to have an infant with omphalocele, an abnormality in which the infant's intestine or other abdominal organs protrude from the navel.

The strongest effect was reported with Paxil, accounting for 36% of all SSRI exposures.

The "Dear Doctor" letter also advised that the study found an association of exposure to any SSRIs with craniosynostosis, a congenital birth defect where the connections between sutures-skull bones, prematurely close during the first year of life, causing an abnormally shaped skull.

Due to the steady stream of reports of birth defects, many experts are speaking out against the prescribing of Paxil, or any other SSRI for that matter, to expectant mothers.

According to neurologist Dr. Fred Baughman, author of the new book, "The ADHD Fraud," antidepressant use during pregnancy is controversial mainly because in psychiatry no actual disease is involved, so such treatment can never be termed essential treatment."

He points out that doctors have always known that prescribing any kind of medication to pregnant women is risky. "We were taught in the Hippocratic medicine of the days since passed that all absolutely non-essential drugs were to be stopped in pregnancy," he says, "that there was no such thing as a completely safe drug."

"And believe it or not," he states, "this was the standard of practice in medicine through the mid-80s or so."

"The field of medicine has sold its soul to Big Pharma," Dr. Baughman says, "especially where psychiatry and psychiatric drugs are concerned."

Over the past several years there have been many reports of studies that show SSRIs pose a risk to the fetus, but according to Dr. Baughman, "for every such report there are 2 or 3 "whitewash" articles from those bought and paid for by industry."

To make his point, he directs attention to Dr. Lee Cohen of Massachusetts General Hospital, the lead author of a study defending the use of SSRIs during pregnancy in the February 2006, Journal of the American Medical Association, that contained the warning that stopping the medication greatly increases the risk of relapsing into depression.

This was of course great news for the drug makers who were facing a growing number of nagging questions about the safety of SSRIs with pregnant women. And critics say it is no coincidence that Dr. Cohen's study just happened to be published around the same time that a study appeared in the New England Journal of Medicine with the warnings of a dangerous breathing problem among babies born to pregnant women who used SSRIs.

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