Child Born with Severe Heart Birth Defects–Paxil Lawsuit Filed

The risk posed by antidepressants, such as Paxil, Prozac, Zoloft, and the other SSRIs and SNRIs has been documented for years, and this month the FDA issued additional warning advisories about the risk these drugs pose for developing babies in the womb.

See: FDA advisory: Pulmonary Hypertensionion: http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm
FDA Advisory: Serotonin Syndrome: http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm

On July 12, 2006, the an investigative report in Wall Street Journal exposed the fact that prominent psychiatrists at Harvard University, failed to disclose their financial ties to the makers of antidepressant drugs in their article in the Journal of the American Medical Association. The dubious rationale given by the psychiatrists for taking antidepressants during pregnancy is the claim that their depression may return. But what of the harm to newborn babies?

The drug industry’s corrosive influence on medicine has turned the Hippocratic Oath on its head: –"First do no harm" takes a back seat to industry’s priority:
Academic medicine is guided by industry’s first principle: First, increase sales — even if this means causing irreversible harm.

 Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>  
 
 
July 28, 2006
FOR IMMEDIATE RELEASE
Baum Hedlund
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233

Cell/weekends: (818) 681-5697
Email:RMcCall@BaumHedlundLaw.com

Child Born with Severe Heart Birth Defects Sues Paxil-Maker

Philadelphia, Pennsylvania, July 28, 2006 — Two-year-old Adrian Vasquez has undergone three open-heart surgeries and now has a pacemaker. His mother took the antidepressant Paxil throughout her entire pregnancy.

Adrian and his parents, Anthony and Matilda Vasquez of Bedford, Texas, filed a lawsuit today against Philadelphia-based GlaxoSmithKline ("GSK"), the maker of Paxil, in Pennsylvania State Court. The family alleges that Mrs. Vasquez’s ingestion of Paxil during her pregnancy resulted in her son being born with severe heart defects. The Vasquez family is seeking an unspecified amount of damages against GSK for failing to warn about the risks associated with Paxil for pregnant women and their unborn children.

According to Baum Hedlund attorney Karen Barth Menzies, who represents the family: "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. The seriousness of these birth defects are such that, at the very first sign of danger, GSK should have issued a strong warning. Over 1 percent — or 40,000 — pregnant women in the US are taking antidepressants. Given the popularity of Paxil, thousands of babies are at risk."

During the last month of her pregnancy, Mrs. Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something very wrong with her baby’s heart. When Adrian was born a few weeks later, on April 19, 2004, in Norfolk, Virginia, he had several life-threatening congenital heart defects. His parents were repeatedly told that his chances of survival were low.

During the first year of his life, Adrian underwent three open-heart surgeries (at eight days, five months and 10 months) due to his heart defects. He also underwent at least four cardiac catheterizations, and at least thirty echocardiograms within the first few months of his life.

Adrian is now two years old and, while he is behind in his verbal and motor skills, his health has improved. Adrian will, however, need repeated heart surgeries as he continues to grow and may need artificial replacement valves, and perhaps eventually a heart transplant. His prognosis is unclear. [See Fact Sheet for more information about the Vasquez family.]

The Vasquez family is represented by Baum Hedlund, a national pharmaceutical products liability law firm in Los Angeles, Washington, D.C. and Philadelphia. [See Fact Sheet for more information about Baum Hedlund.]

In 2003, GSK initiated a retrospective analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of their pregnancies and had given birth to children with major congenital malformations. The analysis showed a more than 2-fold increase for congenital malformations in women taking Paxil compared to other antidepressants.

Another study conducted by researchers in Denmark and published in Pharmacoepidemology and Drug Safety in 2005, also found an association between Paxil and congenital malformations in mothers taking Paxil in the first trimester.

In September 2005, GSK sent out a "Dear Doctor" letter informing physicians throughout the United States that 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. The most common malformations for mothers taking Paxil were cardiovascular, particularly ventricular septal defects ("VSD").

The FDA has issued three Public Health Advisories since December 2005 concerning the risk of congenital heart defects and has changed Paxil’s pregnancy category from C to D, which indicates that "[t]here is positive evidence of fetal risk." [See Fact Sheet for more information.]

A photo is included of Adrian Vasquez taken in March 2005, about a month after his third open-heart surgery. (A higher resolution photo is available upon request through Baum Hedlund.) The family is available for interviews through their attorney, Karen Barth Menzies.

FACT SHEET: Below

Robin McCall
Director of Media Relations
Baum Hedlund
RMcCall@BaumHedlundLaw.com
—————————————

FACT SHEET

The Complaint:
http://www.paxilbirthdefect.com/lawsuit.shtml

General information:

"The American Medical Association estimates that over 1 percent of pregnant women in the US, or more than 40,000, are taking antidepressants." Armstrong, Wall St. Journal http://www.paxilbirthdefect.com/news.shtml

Sales of antidepressants in the US last year exceeded $12.5 billion. Armstrong, Wall St. Journal
http://www.paxilbirthdefect.com/news.shtml

Paxil crosses the placenta, which could have important implications for the developing fetus.
Serotonin (the neurotransmitter that Paxil primarily affects) plays a roll in the fetal development of the heart.
FDA Public Health Advisories Concerning Paxil Birth Defects:
According to an FDA Public Health Advisory dated December 2005
http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm:

A study using a Swedish national registry found a 2-fold increased risk of having an infant with a cardiac defect compared to the entire national registry population.
In another study in the US, women who received Paxil in the first trimester of their pregnancies had a 1.5-fold increased risk of cardiac malformations.

In March/April 2006 http://www.fda.gov/fdac/departs/2006/206_upd.html#paxil , the FDA updated its data on Paxil and the Risk of Birth Defects, explaining that early results of two studies "indicate 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. Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects)." The FDA advised "health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate."

On July 19, 2006 http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm , the FDA issued another Public Health Advisory titled "Treatment Challenges of Depression in Pregnancy." Ironically, the FDA cites a study that warns of depression relapse in women who decide to stop taking their antidepressant, which study has received a great deal of criticism and was the topic of a front-page Wall Street Journal article exposing the fact that most of the authors of the study had undisclosed financial ties to antidepressant manufacturers. http://www.paxilbirthdefect.com/news.shtml Notwithstanding, the new advisory warns of the recent study by Christina Chambers concerning the risk of pulmonary hypertension in babies born to mothers who took antidepressants in their third trimester of pregnancy.

Paxil label re Pregnancy:
In 2003, the prescribing information for Paxil stated: "Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy."

The label also described GSK’s animal studies as having "revealed no evidence of teratogenic effects." ("Teratogen" means any substance with the potential to cause birth defects.) Paxil was identified as a Category C drug (Category C drugs are those in which: "Either animal studies indicate a fetal risk and there are no controlled studies in women, or there are no available studies in women or animals.) The label also stated: "There are no adequate and well-controlled studies in pregnant women." The label further states that Paxil "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."

The FDA has changed Paxil’s pregnancy category from C to D (Category D: "There is positive evidence of fetal risk, but there may be certain situations where the benefit might outweigh the risk (life-threatening or serious diseases where other drugs are ineffective or carry a greater risk).)

Other Complications of Taking Paxil During Pregnancy:

A study published in Teratology Society Abstracts in 2005 reported that women who took Paxil were more likely than those who were not exposed to have an infant with omphalocele (a fetal malformation in which variable amounts of abdominal contents protrude into the base of the umbilical cord) and craniosynostosis (the early closing of one or more of the sutures of an infant’s head, resulting in malformation of the skull). The strongest effect was reported to be with Paxil.
A recent study published in the New England Journal of Medicine (NEJM) by Christina Chambers of the University of California, San Diego, found a six-fold increased risk of persistent pulmonary hypertension (PPH) in infants born to mothers who took an antidepressant in the last trimester of pregnancy.

How Effective are Antidepressants?
There is a general consensus that doctor

s must weigh the benefits of drug treatment versus the risks. In order to do a proper risk benefit analysis, a doctor must be aware of the degree of effectiveness of the drug – not just drug company hype. Is the drug extremely effective or only marginally effective? Doctors know the drug was approved by the FDA, but do they know the FDA’s standards for approving a drug as effective?

In an analysis of efficacy data submitted to the FDA between 1987 and 1999 for six of the most popular selective serotonin reuptake inhibitor (SSRI) antidepressants, including Paxil, 75% to 80% of the response to medication was duplicated in placebo groups.1

These data were the basis on which the medications were approved by the FDA. The researchers explained that the "small difference between the drug response and the placebo response has been a ‘dirty little secret’ known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data …"2

Yet another recent meta-analysis found that SSRIs have "no clinically meaningful advantage over placebo."3

FDA approval of these drugs implies that the data were strong enough and reliable enough to warrant approval, however, as one FDA memo illustrates, the FDA’s standards for approving antidepressants as effective are not robust: "Approval [of the antidepressant] may … come under attack by constituencies that do not believe the agency is as demanding as it ought to be in regard to its standards for establishing the efficacy of antidepressant drug products."

Complicating the risk/benefit analysis further is industry-exaggerated prevalence of illness. Is the mother really suffering from clinical depression or has pharmaceutical marketing done such a tremendous job at "selling sickness" that a pregnant woman who is feeling "down in the dumps" is immediately prescribed a drug that could cause very serious harm to her unborn child. http://bmj.bmjjournals.com/cgi/content/full/324/7342/886