Facts:
Paxil, which has the chemical name is paroxetine, is a widely prescribed antidepressant that has been used by millions of women for the treatment of general depression and anxiety disorders. After a series of studies were published showing that Paxil increased the risks of the development of congenital heart defects among newborns who were exposed during pregnancy, the FDA reclassified Paxil as a Pregnancy Category "D" drug. Category "D" is used when "there is positive evidence of human fetal risk". No other SSRI or antidepressant in the same class carries such a warning.
Pregnant Women
Pregnant women and those who might become pregnant should avoid taking the antidepressant Paxil because of a high risk of birth defects, according to a committee of obstetricians who published their opinion in the December issue of the journal Obstetrics & Gynecology.
The obstetric practice committee of the American College of Obstetricians and Gynecologists said pregnant women should not take Paxil because two previous studies found that the drug posed up to double the risk of heart defects in fetuses.
Nearly a year ago, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline -- which makes Paxil -- changed the warnings on the drug to include the results of the studies. The FDA then advised pregnant women to merely switch from Paxil to another SSRI drug, such as Prozac or Zoloft.
The FDA's enhanced warning on Paxil followed the results of a review of Sweden's birth registry that found pregnant women who took Paxil were 1.5 to 2 times more likely to give birth to a baby with heart defects than women who took other SSRI's or who did not take antidepressants at all.
Neonatal withdrawal symptoms from Paxil have also been documented from mothers taking Paxil during pregnancy.
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Controversy
On October 6, 2006, a US court preliminarily approved a settlement in a class action lawsuit brought on behalf of everyone in the United States who purchased Paxil(R) or Paxil CR(TM) prescribed for consumption by a minor child. The lawsuit alleges that GlaxoSmithKline promoted Paxil(R) or Paxil CR(TM) for prescription to children and adolescents while withholding and concealing material information about the medication's safety and effectiveness for minors. GSK denies all claims. If approved, the Proposed Settlement will provide $63.8 million to pay consumers, who submit valid Claim Forms,
cash for the total amount they paid for Paxil(R) or Paxil CR(TM). Eligible Class Members can get up to 100% of the amount paid for Paxil(R) or Paxil CR(TM).
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The Court will hold a Final Approval Hearing on March 9,2007. At that time, the Court will consider whether to approve the Proposed Settlement and award attorneys' fees and costs.
In March 2004 the FDA placed a black box warning on SSRI and other antidepressants, warning of the risk for potential suicidal thinking in children and adolescents. ABC News reported that the prescribing of these medications to children subsequently dropped by 20 percent. According to the Center for Disease Control and Prevention's Annual Summary of Vital Statistics, the suicide rate rose more than 18 percent in those 1 to 19 years old, from 2.2 per 100,000 in 2003 to 2.6 per 100,000 in 2004. In those 15 to 19 years old, the figures reflected a more than 12 percent rise in suicide, from 7.3 per 100,000 in 2003 to 8.2 per 100,000 in 2004. This led many experts to conclude that the warning, and subsequent
reduction in the use of antidepressants, led to an increased suicide rate in this age group. The finding is consistent with an earlier finding - reported to the 2003 FDA Advisory Committee by Dr David Shaffer - which showed that suicide rates in the United States fell during the 1990s, in line with the introduction
of SSRI’s.
Since the FDA approved paroxetine in 1992, approximately5,000 U.S. citizens have sued GSK. Most of these people feel they were not sufficiently warned in advance of the drug's side effects.
Paroxetine or paroxetine hydrochloride is a selective serotoninreuptake inhibitor (SSRI) antidepressant. It was released in 1992 by the pharmaceutical company GlaxoSmithKline and has since become one of the most prescribed antidepressants on the market due to its apparent efficacy in treating depression as well as a spectrum of anxiety disorders ranging from panic attacks to phobias. The prescription of this drug is currently controversial because of legal proceedings against the manufacturer.
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