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Parents Enraged At Glaxo Over Paxil Birth Defects

Parents Enraged At Glaxo Over Paxil Birth Defects

By Evelyn Pringle

On July 28, 2006, a lawsuit was filed in Philadelphia against GlaxoSmithKline, on behalf of Adrian Vasquez, an infant born on April 19, 2004, with life-threatening congenital heart defects as a result of his mother having been prescribed Paxil during pregnancy.

Since birth, beginning when he was 8 days old, Adrian has undergone three open heart surgeries in an attempt to repair his heart. Each time, his parents were advised that his chance for survival was low.

In addition to the surgeries, he also underwent at least four cardiac catheterizations, and thirty echocardiograms within the first few months of his life. In March 2005, surgeons operated on Adrian again to install a pacemaker.

He remained hospitalized for nearly a year before being released on April 3, 2006, just 2 weeks short of his first birthday.

As Adrian matures, experts say, he will need repeated surgeries to replace a conduit, maintain the pacemaker, and have artificial replacement valves inserted into his heart. Even then, they say, he may end up needing a heart transplant.

Mrs. Vasquez first learned that there were problems with her baby's heart during an ultrasound in her last month of pregnancy. She had taken Paxil throughout her pregnancy.

Baum Hedlund, a national pharmaceutical products liability law firm in Los Angeles, Washington, D.C. and Philadelphia, represents the Vasquez family. According to Baum Hedlund attorney Karen Barth Menzies:

"Adrian Vasquez is a tough little boy. The trauma he has endured in his brief two years of life is much more than most of us will ever have to suffer in our entire lifetime."

It is now known that in 2003, GSK conducted an analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of pregnancy and given birth to infants with major congenital malformations. The analysis showed a more than 2-fold increase for malformations in women taking Paxil compared to other antidepressants.

According to Ms. Menzies, "The seriousness of these birth defects are such that, at the very first sign of danger, GSK should have issued a strong warning."

It stands to reason, experts say, that because doctors and patients were not made aware of the problem, there are probably infants with heart defects all over the country whose parents have no idea that they were caused by Paxil.

Ms. Menzies points out that over 1 percent -- or 40,000 -- pregnant women in the US are taking antidepressants. "Given the popularity of Paxil," she warns, "thousands of babies are at risk."

She may be right, because more cases of this type of birth defect are showing up in the media. On August 2, 2006, Texas Cable News reported heart defects in a 9-month-old baby from Brazoria County, Texas born to a mother who had taken Paxil during the first trimester of pregnancy, who was at the time of the broadcast, on life-support surviving with only half a heart.

According to the broadcast, this infant has already undergone one open-heart surgery and has made at least a dozen trips to the emergency room.

The mother, Lisa Collins, told Texas Cable News that she believes it could have all been prevented had her doctor warned her not to continue taking Paxil.

Lisa is probably right but the problem is that Glaxo did not warn doctors about the risk of heart defects until September 2005, when the company sent out a "Dear Doctor" letter saying the results of its analysis showed a higher rate of "congenital malformations associated with the use of Paxil as compared to other antidepressants" in infants born to women taking antidepressants during the first trimester of pregnancy.

For its part, since December 2005, the FDA has issued three Public Health Advisories about the risk of congenital heart defects and has upgraded Paxil’s pregnancy category from C to D, which indicates that there is positive evidence of fetal risk.

The Vasquez family lawsuit alleges in part, that Glaxo was negligent in, "Failing to fully disclose the results of the testing and other information in its possession regarding the possibility that Paxil can interfere with the proper development of an unborn fetus."

The complaint specifically charges that, "GSK promoted Paxil for use with pregnant women despite the fact that GSK knew or should have known that Paxil is associated with an increased risk of congenital abnormalities."

The FDA initially approved Paxil in 1992, and due to an aggressive marketing campaign by Glaxo, it quickly became one of the most popular drugs worldwide. Paxil belongs to the class of antidepressants known as the selective serotonin reuptake inhibitors (SSRIs).

However, over the past couple of years, studies have linked Paxil to a variety of serious birth defects. In September 2005, Glaxo sent out a "Dear Doctor letter" advising healthcare professionals of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI were more likely to have an infant with omphalocele, an abnormality in which the infant's intestine or other abdominal organs protrude from the navel.

The strongest effect was reported with Paxil, accounting for 36% of all SSRI exposures.

The "Dear Doctor" letter also advised that the study found an association of exposure to any SSRIs with craniosynostosis, a congenital birth defect where the connections between sutures-skull bones, prematurely close during the first year of life, causing an abnormally shaped skull.

Due to the steady stream of reports of birth defects, many experts are speaking out against the prescribing of Paxil, or any other SSRI for that matter, to expectant mothers.

According to neurologist Dr. Fred Baughman, author of the new book, "The ADHD Fraud," antidepressant use during pregnancy is controversial mainly because in psychiatry no actual disease is involved, so such treatment can never be termed essential treatment."

He points out that doctors have always known that prescribing any kind of medication to pregnant women is risky. "We were taught in the Hippocratic medicine of the days since passed that all absolutely non-essential drugs were to be stopped in pregnancy," he says, "that there was no such thing as a completely safe drug."

"And believe it or not," he states, "this was the standard of practice in medicine through the mid-80s or so."

"The field of medicine has sold its soul to Big Pharma," Dr. Baughman says, "especially where psychiatry and psychiatric drugs are concerned."

Over the past several years there have been many reports of studies that show SSRIs pose a risk to the fetus, but according to Dr. Baughman, "for every such report there are 2 or 3 “whitewash” articles from those bought and paid for by industry."

To make his point, he directs attention to Dr. Lee Cohen of Massachusetts General Hospital, the lead author of a study defending the use of SSRIs during pregnancy in the February 2006, Journal of the American Medical Association, that contained the warning that stopping the medication greatly increases the risk of relapsing into depression.

This was of course great news for the drug makers who were facing a growing number of nagging questions about the safety of SSRIs with pregnant women. And critics say it is no coincidence that Dr. Cohen's study just happened to be published around the same time that a study appeared in the New England Journal of Medicine with the warnings of a dangerous breathing problem among babies born to pregnant women who used SSRIs.

In the February 9, 2006, NEJM, Christina Chambers, PhD, MPH, and colleagues at the University of California in San Diego, found the use of SSRIs during late pregnancy was associated with persistent pulmonary hypertension in newborns.

The research team reported that 14 infants developed PPHN after being exposed to an SSRI after the 20th week of pregnancy, compared with only 6 infants in the control group. The researchers calculated an increased risk of 6-fold in infants exposed to SSRIs.

"The frequency of infant death up to the time of maternal interview was 3% in the persistent pulmonary hypertension group and 0% in the control group," the study noted.

In contrast, the authors said, the use of non-SSRI antidepressants at any time during pregnancy was not associated with an increased risk of PPHN.

Infants born with the disorder often require mechanical assistance to breathe and between 10 and 20% die soon after birth. Those infants who do survive often experience developmental delays, hearing loss and brain abnormalities.

In July 2006, late on the draw as usual, the FDA finally got around to adding the warning about PPHN to the Paxil information sheet to state:

"The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal."

"Babies born with PPHN," the FDA wrote, "have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die."

Critics say, Dr. Cohen's study was clearly published in JAMA to overshadow the bad publicity that was sure to follow the news about the lung disorder. However, according to Dr. Baughman, a fact not mentioned in the study, is that Dr. Cohen is on the paid speakers bureau for numerous drug companies.

In fact, as it turns out, Dr. Cohen has conflicts of interest stemming from all directions. According to the July 11, 2006, Wall Street Journal, he "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 also failed to mention that most of the other 13 authors were paid as consultants or lecturers. "In total," the WSJ reports, "the authors failed to disclose more than 60 different financial relationships with drug companies."

And come to find out, besides publishing the study, Dr. Cohen and some of the other authors hit the lecture circuit, traveling around the country telling doctors about their findings while pointing out flaws in studies that found increased risks of health problems with infants associated with mothers who used SSRIs during pregnancy.

When contacted by the WSJ, the editor-in-chief of JAMA, Catherine DeAngelis, said the journal was not aware at the time the study was published of the relationships Dr. Cohen and some of the co-authors had with drug companies.

"As soon as JAMA found out that they didn't disclose," she said, "we contacted the corresponding author, Dr. Cohen, and asked for his explanation."

"We have one and it will be published very soon in an upcoming issue of JAMA," she added.

Dr. Cohen’s response in JAMA was to say the study did not address the question of whether "antidepressants as a whole or a particular antidepressant" should be prescribed and so he and his colleagues saw no potential conflict of interest.

According to Dr. Baughman, "JAMA, and all journals, should be made to publish clear, detailed statements regarding all of their financial ties."

"Only then," he says, "will readers be able to understand why they say what they say and advocate as they do, often regardless of proof and credible science."

Academic researchers like Dr. Cohen are referred to in the industry as "opinion" or "thought" leaders and are reportedly chosen on the basis of their ability to influence not only prescribing doctors, but also public opinion. The WSJ describes their importance in relation to SSRIs as:

"In the case of antidepressant use during pregnancies, the industry-paid opinion leaders have become dominant authorities in the field. They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors."

For years, Big Pharma has pursued the cream of the crop in America's medical profession when recruiting doctors and researchers to serve as product shills. They promote drugs by setting up interviews in the media. They convince other doctors to prescribe drugs off-label for non-approved uses at seminars using elaborate presentations provided by drug companies and serve on boards of universities, foundations and professional bodies.

But the most sought after, critics say, are those medical professionals involved in formulating approved drug lists for programs like Medicare and Medicaid, where a decision to favor one drug over the other can mean billions of dollars to the "winning" drug companies.

In the case of the SSRIs, instructing pregnant women not to use the drugs could have an immediate negative impact on sales figures. The February 9, 2006 Union-Tribune, reported that at a Washington news conference on February 8, 2006, in response to the study that revealed the lung disorder, FDA official, Dr. Sandra Kweder, called the "findings significant” and “worrisome,” especially because 10 percent to 15 percent of women of reproductive age have major depression and are the biggest users of antidepressant drugs."

Ten to 15% of all women of childbearing age represent an enormous chunk of the market. In the case of Paxil, it’s worse because the drug is also prescribed to treat mood disorders which means many more pregnant women than expected may be using the drug.


Families seeking justice for infants born with Paxil related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087.

Evelyn Pringle

Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department,,

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