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GlaxoSmithKline Sued Over Paxil Birth Defects

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"What we've found, Dr Zeskind said, "is that SSRIs disrupt the neurological systems of children, and that this is more than just a possibility, and we're talking about hundreds of thousands of babies being exposed to these drugs during pregnancy."

"These babies," he said in the February 22, 2004, Sunday Telegraph "are bathed in serotonin during a key period of their development and we really don't know what it's doing to them or what the long-term effects might be."

"It could be that they go 'cold turkey' when they are born," he advised, "or the serotonin could be having an effect on their brains, or it could be a bit of both."

In June 2004, a few months after the Pediatrics article appeared, a study published in Prescrire International, also found that newborns exposed to SSRIs toward the end of pregnancy showed signs of agitation, altered muscle tone, and breathing and suction problems, with an estimated 20% to 30% of the infants in the study affected.

And the adverse events were reported with the use of all SSRIs.

Many researchers say they are unable to determine for certain whether infants with SSRI-associated problems at birth, are suffering from drug withdrawal or whether SSRIs are having a toxic effect on their systems. "The symptoms," the Prescrire research said, "are variously attributed to withdrawal or to the drug itself."

"In practice," the researchers advised, "doctors should be aware of this risk when considering antidepressant treatment for women in the third trimester of pregnancy."

On June 9, 2004, Web MD reported that the FDA was concerned because the "agency has received hundreds of preliminary reports of adverse effects in newborns over the last decade."

Adverse effects were wide-ranging, but the most common included trouble eating, irritability, body rigidity, and respiratory trouble, according to Kathleen Phelan, a safety evaluator in the FDA's division of drug risk evaluation.

The reports suggest, Web MD noted, that infants whose mothers take SSRIs can experience withdrawal symptoms or toxicity after delivery.

The FDA also recorded 19 adverse events in pregnant women who took Effexor, an antidepressant closely related to SSRIs, including seizures, jitteriness, and jaundice.

The following month in July 2004, the adverse event reports prompted the FDA to change the labeling for all SSRIs, warning that newborns exposed to SSRIs have developed problems requiring prolonged hospitalizations, respiratory support, and tube feeding.

In October 2004, researchers from Columbia University published a study in the journal, Science, suggesting that exposure to Prozac in the womb and in early childhood may permanently alter the brain's circuitry and disrupt neural development, leading to serious emotional disorders later in life.

In February 2005, Spanish researchers reported the use of SSRIs was associated with neonatal withdrawal syndrome, in the medical journal, Lancet.

The study by a team at the University of La Laguna in Spain found symptoms of the withdrawal syndrome to include convulsions, irritability, abnormal crying and tremor.

For this study, researchers reviewed the World Health Organization database of adverse reactions for neonatal convulsions and neonatal withdrawal syndrome associated with the use of SSRIs from 72 coutries. By November 2003, they found there were a total of 93 reported cases of SSRI use associated with either neonatal convulsions or withdrawal syndrome.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
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