Paxil And Babies

A Danish study published in September 2009, entitled “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study” resulted in an important conclusion. It is cited at BMJ 2009;339:b3569.  Medical experts in the Departments of Epidemiology, Pediatrics and General Practice at the Institute of Public Health, Aarhus University, Denmark, and the UCLA School of Public Health, Department of Epidemiology, collaborated in the study.

The study’s Objective was “to investigate any association between selective serotonin reuptake inhibitors (SSRIs) taken during pregnancy and congenital major malformations.”  It included 493,113 children born in Denmark from 1996-2003.  It found that SSRIs “were associated with septal heart defects.”

The doctors and researchers concluded that there “is an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy.”

There are potential dangers to the developing baby of women who get pregnant while taking paroxetine, or who start it after getting pregnant.  We are involved in cases where women took Paxil in various trimesters of pregnancy.  The cases usually involve allegations of fetal heart damage when the mother took Paxil early in the pregnancy.

However, Glaxo’s www.gsk.com own literature shows that newborns who were exposed to Paxil and other SSRIs or SNRIs (selective serotonin and norepinephrine reuptake inhibitors) late in pregnancy have at times developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Paxil related complications in newborns may include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.

Depression affects as many as 25% of pregnant women.   Figures from 2003 show that about an eighth of pregnant women take antidepressants at one time or another during pregnancy.    Many antidepressants appear to be fairly safe for the unborn babies of those pregnant women, but studies report links between maternal use and an increased risk of some fetal malformations, particularly the heart.

Please remember that there are time limits (statutes of limitation) for any claim involving Paxil.  Many lawyers claim to have expertise in such cases but only two Paxil trials were ever won by patients.  If you want to know more about the one in which we were privileged to serve, please go to www.fitzgeraldlaw.com/verdicts and scroll down to Tobin.  There you will find links to various parts of the case.

Please remember that there are time limits (statutes of limitation) for any claim involving Paxil.  Many lawyers claim to have expertise in such cases but only two Paxil trials were ever won by patients.  If you want to know more about the one in which we were privileged to serve, please go to www.fitzgeraldlaw.com/verdicts and scroll down to Tobin.

Long-time readers of this blog know that GlaxoSmithKline lost the trial in which we were privileged to serve as co-trial counsel, its first loss for the death of an adult over its drug.  Now that it has lost its trial in the case of a baby damaged by Paxil (paroxetine), GSK would like us to doubt that verdict should stand.  However, scientific and medical studies support the jury’s decision.  These studies have shown that Paxil puts infants at increased risk for cardiac malformations and pulmonary hypertension.

A Swedish study showed that infants in the womb who were exposed to paroxetine during pregnancy had a 2% increased risk of heart malformations.  These defects can occur in two ways.  The first is ventricular septal defects (VSD).  The second category is atrial septal defects (ASD).  Some of these were so severe that they required surgical repair.

A United States study included 5,956 infants of mothers who had taken antidepressants during the first three months of pregnancy.  It found a 50% increase in the risk for heart malformations in infants whose mothers took Paxil compared to other antidepressants.  This study, like the Swedish study, showed the injuries included cardiovascular defects  and other major congenital malformations.

In any study, there should be a reasonably large group of people.  Two more case-control studies used separate databases.  Each one studied more than 9,000 birth defect cases and more than 4,000 controls.  These two additional studies found that fetal exposure to Paxil during the first trimester caused a two to three times increase in right ventricular outflow tract obstructions.

The British Medical Journal has reported a connection between the use of antidepressants by pregnant women and an increased risk for a common heart defect in babies. The antidepressants are in the class of drugs known as SSRIs (selective serotonin reuptake inhibitors). Paxil is an SSRI. The article is entitled: “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study”

Another esteemed journal, The Archives of Pediatrics & Adolescent Medicine, reported in October 2009 that babies born to mothers who used SSRIs were more likely to have Apgar low scores. Doctors and nurses score newborns in the first five minutes of life on the Apgar scale. It is babies an overall measure of newborn health. The article is abstracted at http://archpedi.ama-assn.org/cgi/content/full/163/10/949

A teratogenic agent is one that can cause birth defects. Glaxo ignored links between Paxil and birth defects for 20 years. Glaxo was told of the links that showed that Paxil was teratogenic but kept marketing it anyway.

With more than 600 cases filed in court alleging that Glaxo knew Paxil caused birth defects and that it hid those risks to pump up profits, Glaxo has a lot of explaining to do. Approved for U.S. use in 1992-without Glaxo revealing to the FDA that it could be dangerous to developing babies, the drug generated about $942 million (nearly a billion) in sales last year, 2.1 percent of Glaxo’s total sales.

When SmithKlineBeecham (now www.gsk.com) introduced its anti-depressant Paxil in 1992, the United States Food and Drug Administration www.fda.gov classified it as a drug with no known links to increased birth defects. The FDA did so, based upon the representations of the manufacturer. However, a recent court trial for a baby damaged by Paxil showed that Glaxo learned long ago that a link existed. Glaxo was not forthcoming with that information but the court battle brought it to light.

Based upon that evidence, the jury ordered Glaxo to pay $2.5 million for a baby who was born with serious heart defects after his mother took Paxil during her pregnancy. The evidence showed what Glaxo knew and when it knew it.

Glaxo started getting reports of adverse events from patients and healthcare providers in the late 1990s. Although these reports should have alarmed Glaxo, it did not issue warnings. Finally the FDA required it to change its warning in 2005, based upon adverse events reports.

The warnings require that Glaxo notify patients and health care providers that Paxil may be associated with birth defects. Mothers who took it during pregnancy and whose children were born with heart malformations and other problems may now know why that happened.

There are about 600 cases like the recent trial. Now that the evidence is in the public record, we hope that these cases will result in justice all across America for mothers who took Paxil and whose babies were born with heart problems and other defects.

GlaxoSmithKline has to pay for ignoring evidence that its antidepressant Paxil could cause birth defects. The evidence in the recent birth defect trial showed that Glaxo told its scientists to avoid disclosing possible risks associated with the drug’s use by pregnant women. The jury determined that the risks should have been disclosed, and that the evidence of an association between Paxil use in pregnancy and birth defects like heart malformations was important.

The jury rejected the arguments by Glaxoís counsel that there was no evidence that Paxil caused this babyís heart problems, and it awarded $2.5M in its verdict to take care of the baby. The evidence at trial showed that Glaxo knew before it put Paxil on the market that rats administered the drug had a higher death rate in their pups. Also, around the same time as the rat study in the 1980ís, one of Glaxoís own scientists warned his higher-ups that “there remains the possibility that this compound could be teratogenic,î a cause of birth defects, at higher dose levels. Teratology is the study of abnormal physiological development. The public had a right to know about the potential of teratogenic effects in this highly profitable drug.

Good news. Here’s what Bloomberg had to say about the verdict yesterday against GSK over the dangers of Paxil for pregnant mothers and their babies. We are gratified that Bloomberg also mentioned the Cheyenne, Wyoming trial in which we were privileged to serve as trial counsel. Now there have been two verdicts against GSK, the one in Cheyenne and yesterday’s.

“GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid the risk to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue”.

In the Kilker case, the jury found that Glaxo officials “negligently failed to warn” the doctor treating Lyam’s mother about Paxil’s risks and concluded the medicine was a “factual cause” of the child’s heart defects.

Juror Joe Mellon, who voted for Kilker, said Glaxo didn’t conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” Mellon said after the verdict was announced.”
“Glaxo is also fighting suits in the U.S., Canada and the U.K. over claims that Paxil, whose generic name is paroxetine, causes homicidal and suicidal behavior. The company settled some suicide claims, under undisclosed terms.”
“In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled while on appeal, according to Glaxo’s Mr. Colgan.”