Of these cases, 64 involved Paxil,
In the September 2005, Journal of Psychopharmacology, Vol 19, No 5, 554-557 (2005), researchers discussed the uncertainty of whether the symptoms found with infants at birth represent Paxil (paroxetine) toxicity or a discontinuation syndrome.
"Serotonin toxicity due to paroxetine seems the most likely mechanism," the Journal wrote, "though an important differential diagnosis is a paroxetine discontinuation (withdrawal) syndrome."
The infant's symptoms began on the first day after birth and persisted for 10 days even though levels of paroxetine were undetectable on day 6, the study found. "Differentiating between these two syndromes," they said, "in the neonate presents a dilemma for clinicians."
Irrespective of the mechanism, the authors of the study said that all infants exposed to SSRIs during the last trimester should be followed closely for adverse symptoms in the first 10 days after birth and the possibility of such symptoms should be discussed with women who are considering starting or continuing SSRI treatment in pregnancy.
In September 2005, Glaxo sent out a "Dear Doctor" letter advising health care professionals of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRIs were more likely to have an infant with omphalocele (abnormality in which the infant's intestine or other abdominal organs protrude from the navel).
However, the strongest effect was reported with Paxil, which accounted for 36% of all SSRI exposures.
In addition, the "Dear Doctor" letter advised that the authors of the study above also found an association of exposure to SSRIs and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)
Also in September 2005, studies conducted by Danish and US researcher determined that 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 cardiac defects appeared to be 60% more likely when women used SSRIs.
In one study, focusing on 1,054 women who took SSRIs during pregnancy, scientists also found that use of the drugs late in pregnancy was associated with a 40% increased risk of premature birth.
And a second study of 377 cases of persistent pulmonary hypertension in babies found SSRI use late in pregnancy was linked a 5.5-fold increased risk.
The findings of the studies were presented an International Society for Pharmacoepidemiology conference and featured in Pulse magazine.
Three months later, on December 8, 2005, the FDA issued a public safety alert about the results of Paxil studies, suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.
The advisory was based on the preliminary results of two studies. The first involved an evaluation of US health insurer data that found about 2% of women who took Paxil early in pregnancy gave birth to infants with heart defects, compared to about 1% of all women.
The second study reviewed records on about 6,900 infants in Sweden, and found that 1.5% of women taking Paxil in their first trimester gave birth to infants with heart defects, verses 1% of women who took other antidepressants.
"The early results of two studies," the FDA said, "showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population."
In the September 2005, Journal of Psychopharmacology, Vol 19, No 5, 554-557 (2005), researchers discussed the uncertainty of whether the symptoms found with infants at birth represent Paxil (paroxetine) toxicity or a discontinuation syndrome.
"Serotonin toxicity due to paroxetine seems the most likely mechanism," the Journal wrote, "though an important differential diagnosis is a paroxetine discontinuation (withdrawal) syndrome."
The infant's symptoms began on the first day after birth and persisted for 10 days even though levels of paroxetine were undetectable on day 6, the study found. "Differentiating between these two syndromes," they said, "in the neonate presents a dilemma for clinicians."
In September 2005, Glaxo sent out a "Dear Doctor" letter advising health care professionals of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRIs were more likely to have an infant with omphalocele (abnormality in which the infant's intestine or other abdominal organs protrude from the navel).
However, the strongest effect was reported with Paxil, which accounted for 36% of all SSRI exposures.
In addition, the "Dear Doctor" letter advised that the authors of the study above also found an association of exposure to SSRIs and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)
Also in September 2005, studies conducted by Danish and US researcher determined that 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 cardiac defects appeared to be 60% more likely when women used SSRIs.
In one study, focusing on 1,054 women who took SSRIs during pregnancy, scientists also found that use of the drugs late in pregnancy was associated with a 40% increased risk of premature birth.
And a second study of 377 cases of persistent pulmonary hypertension in babies found SSRI use late in pregnancy was linked a 5.5-fold increased risk.
The findings of the studies were presented an International Society for Pharmacoepidemiology conference and featured in Pulse magazine.
Three months later, on December 8, 2005, the FDA issued a public safety alert about the results of Paxil studies, suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.
The advisory was based on the preliminary results of two studies. The first involved an evaluation of US health insurer data that found about 2% of women who took Paxil early in pregnancy gave birth to infants with heart defects, compared to about 1% of all women.
The second study reviewed records on about 6,900 infants in Sweden, and found that 1.5% of women taking Paxil in their first trimester gave birth to infants with heart defects, verses 1% of women who took other antidepressants.
"The early results of two studies," the FDA said, "showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population."
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