The Shore lawsuit also names the doctor who prescribed the Celexa as a defendant and accuses him of failing to exercise the ordinary care and diligence exercised by other doctors in similar circumstances by continuing to prescribe Celexa after "a multitude of literature and studies" confirmed the association of Celexa and birth defects and without alerting the plaintiff of the dangers of drug.
And the warnings about SSRI use during pregnancy have been many and continuous over the last decade. As far back as 1996, a study published in the NEJM that compared 228 pregnant women taking the SSRI, Prozac and 254 women who did not take the drug, between 1989 and 1995, found that among the 97 infants exposed to Prozac who were evaluated for minor anomalies, the incidence of three or more anomalies was significantly higher than among the 153 infants examined who were born to women who did not take Prozac, by a 15.5% to 6.5% margin.
In 2003, a study in the American Journal of Psychiatry reported that SSRIs medications readily cross the placental barrier and expose the infant to increased serotonin levels during early development.
In February 2004, a study published in the journal Pediatrics, said pregnant women who used SSRIs could be damaging the brains of their unborn babies and specifically noted the changes in heart rates. The study of 34 mothers and their babies found direct evidence of a link between fetal exposure to SSRIs and disrupted neurological development. The researchers linked abnormal heart rhythms, sleeping patterns, and levels of alertness to the drugs.
Lead researcher Philip Zeskind, a professor of pediatrics at the University of North Carolina-Chapel Hill, said that a study of 34 babies might be small, but that the results were "alarming" and demanded a follow-up.
His team compared 17 babies born to mothers who took Celexa, Prozac, Paxil, or Zoloft with 17 babies born to mothers who had never taken SSRIs.
Babies exposed to the drugs tended to be locked in one "sleep state," Professor Zeskind said, and showed "fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants."
Five months later on June 9, 2004, nearly two years before the birth of Gavin Shore, Web MD reported that the FDA was concerned by reports suggesting that SSRIs may cause adverse health effects in newborns when mothers take the drugs late in pregnancy.
Web MD said the FDA had received hundreds of preliminary reports of adverse effects in newborns over the last decade and had received reports involving all SSRIs on the market, including Prozac, Paxil, Luvox, Zoloft, and Celexa.
The reports suggest, Web MD noted, that infants whose mothers took the medications can experience drug withdrawal symptoms or toxicity after delivery. Effects were wide-ranging, and the most common included trouble eating, irritability, body rigidity, and respiratory trouble, said Kathleen Phelan, a safety evaluator in the FDA's division of drug risk evaluation.
In July 2004, these reports prompted the FDA to change the labeling for the entire SSRI class of drugs, warning that some newborns exposed to SSRIs had developed problems requiring respiratory support, prolonged hospitalizations, and tube feeding.
"What we want them to do is realize there are things that happen to neonates when moms take these drugs that need to be considered," said Katherine Wisner, MD, a professor of psychiatry and obstetrics at the University of Pittsburg and a member of the FDA pediatric drug advisory panel.
On February 4, 2005, BBC News reported a study in the journal Lancet, in which researchers had screened the World Health Organization's database on adverse drug reactions for cases of neonatal convulsions and neonatal withdrawal syndrome and found that by November 2003, a total of 93 cases of maternal SSRI use in babies born with convulsions or withdrawal syndrome had been reported.
When these cases were analyzed, 64 were associated with Paxil, 14 with Prozac, nine with Zoloft, and 7 with Celexa.
Also writing in the Lancet, researchers at Yale University School of Medicine said it would be wrong to assume that withdrawal syndrome was only associated with Paxil use.
Dr Vladislav Ruchkin said: "From a pessimistic extreme, these reports might jointly herald the beginning of the end for the uncontested SSRI hegemony of the past decade."
And the warnings about SSRI use during pregnancy have been many and continuous over the last decade. As far back as 1996, a study published in the NEJM that compared 228 pregnant women taking the SSRI, Prozac and 254 women who did not take the drug, between 1989 and 1995, found that among the 97 infants exposed to Prozac who were evaluated for minor anomalies, the incidence of three or more anomalies was significantly higher than among the 153 infants examined who were born to women who did not take Prozac, by a 15.5% to 6.5% margin.
In 2003, a study in the American Journal of Psychiatry reported that SSRIs medications readily cross the placental barrier and expose the infant to increased serotonin levels during early development.
In February 2004, a study published in the journal Pediatrics, said pregnant women who used SSRIs could be damaging the brains of their unborn babies and specifically noted the changes in heart rates. The study of 34 mothers and their babies found direct evidence of a link between fetal exposure to SSRIs and disrupted neurological development. The researchers linked abnormal heart rhythms, sleeping patterns, and levels of alertness to the drugs.
His team compared 17 babies born to mothers who took Celexa, Prozac, Paxil, or Zoloft with 17 babies born to mothers who had never taken SSRIs.
Babies exposed to the drugs tended to be locked in one "sleep state," Professor Zeskind said, and showed "fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants."
Five months later on June 9, 2004, nearly two years before the birth of Gavin Shore, Web MD reported that the FDA was concerned by reports suggesting that SSRIs may cause adverse health effects in newborns when mothers take the drugs late in pregnancy.
Web MD said the FDA had received hundreds of preliminary reports of adverse effects in newborns over the last decade and had received reports involving all SSRIs on the market, including Prozac, Paxil, Luvox, Zoloft, and Celexa.
The reports suggest, Web MD noted, that infants whose mothers took the medications can experience drug withdrawal symptoms or toxicity after delivery. Effects were wide-ranging, and the most common included trouble eating, irritability, body rigidity, and respiratory trouble, said Kathleen Phelan, a safety evaluator in the FDA's division of drug risk evaluation.
In July 2004, these reports prompted the FDA to change the labeling for the entire SSRI class of drugs, warning that some newborns exposed to SSRIs had developed problems requiring respiratory support, prolonged hospitalizations, and tube feeding.
"What we want them to do is realize there are things that happen to neonates when moms take these drugs that need to be considered," said Katherine Wisner, MD, a professor of psychiatry and obstetrics at the University of Pittsburg and a member of the FDA pediatric drug advisory panel.
On February 4, 2005, BBC News reported a study in the journal Lancet, in which researchers had screened the World Health Organization's database on adverse drug reactions for cases of neonatal convulsions and neonatal withdrawal syndrome and found that by November 2003, a total of 93 cases of maternal SSRI use in babies born with convulsions or withdrawal syndrome had been reported.
When these cases were analyzed, 64 were associated with Paxil, 14 with Prozac, nine with Zoloft, and 7 with Celexa.
Also writing in the Lancet, researchers at Yale University School of Medicine said it would be wrong to assume that withdrawal syndrome was only associated with Paxil use.
Dr Vladislav Ruchkin said: "From a pessimistic extreme, these reports might jointly herald the beginning of the end for the uncontested SSRI hegemony of the past decade."
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