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Forest Labs Bogged Down With Celexa Legal Woes

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He warned that until further research refuted the findings, it would be best to focus on non-drug therapies with pregnant women.

On September 1, 2005, BBC reported that Danish and US scientists found the use of SSRIs in the first three months of pregnancy was linked to a 40% increased risk of birth defects such as cleft palate, and that cardiac birth defects appeared to be 60% more likely when women used SSRIs.

In the study of 1,054 women who took SSRIs during pregnancy, scientists found that the use of the drugs late in pregnancy was also associated with a 40% increased risk of premature birth which in turn studies show, leads to a high rate of infant mortality.

The October 2006, issue of Pediatrics, citing a study by CDC researchers, reported that preterm birth is the leading cause of infant mortality in the US, accounting for at least a third of all babies' deaths in 2002.

The contribution of prematurity to infant mortality may be twice as high as originally estimated, said William Callaghan, MD, MPH, and CDC colleagues, in Pediatrics.

The researchers reviewed the top 20 causes of infant deaths in 2002, and found that 34% of the deaths occurred in preterm infants. The top cause of death overall was: Congenital malformations, deformations, and chromosomal abnormalities, occurring in 5,630 infants, 49.5% of whom were preterm.

In addition, the October 3, 2006 issue of the Archives of Pediatrics and Adolescent Medicine reported a study that found some low birth weight infants with no visible disability at birth were found to have subtle motor and cognitive deficits at age 16.

The authors noted that "independent of social risk, specific prenatal, perinatal and neonatal biological risk factors are associated with cognitive and motor outcomes as late as adolescence runs counter to the view that, absent severe disability, early biological risk factors are of little importance in later life."

On December 8, 2005, the FDA issued a health advisory saying exposure to the SSRI, Paxil, in the first trimester of pregnancy may increase the risk of congenital malformations citing a Swedish study of 6,896 women that found a doubling of cardiac birth defects among infants born to mothers who use Paxil, compared to infants in the general population.

On April 7, 2006, the BBC reported that a Canadian study from the University of Ottawa, of almost 5,000 mothers found those who used SSRIs during pregnancy were twice as likely to have a premature baby and almost twice as likely to have low birth weight babies and stillbirths.

In July 2006, the FDA addressed 2 studies related to the use of SSRIs during pregnancy. "The first study," it said, "illustrates the potential risk of relapsed depression after stopping antidepressant medication during pregnancy."

The women who stopped their medicine, the FDA noted, were five times more likely to have a relapse of depression during pregnancy than the women who continued to take the antidepressants while pregnant. The study cited was lead by Dr Lee Cohen and other authors, and was published February 1, 2006 in the Journal of the American Medical Association.

However, on July 11, 2006, the Wall Street Journal disclosed that the study in JAMA claiming that pregnant women who stopped taking SSRIs were likely to relapse, was published by authors with financial ties to the makers of the SSRIs.

The study, the WSJ said, "and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants."

"The lead author -- Lee S. Cohen," the Journal wrote, "is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers."

"The study reported financial relationships," the article noted, "for two of the 13 authors of the study, Emory's Drs. Stowe and Jeffrey Newport."

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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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