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Paxil Birth Defects
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Paxil Birth Defects

paxil side effects, birth defects lawsuit

Paxil Lawsuits: Side Effects of AntiDepressant Linked To Birth Defects, Heart Malformation

Paxil Birth Defects Lawsuits | Side Effects include: Heart Malformations, Ventricular Septal Defects, Antidepressants

Paxil Birth Defects Victims currently represented by Parker Waichman LLP Attorneys

In 2005, the Food & Drug Administration (FDA) warned that the antidepressant Paxil had been linked to an increased risk of birth defects, particularly heart defects, and asked GlaxoSmithKline to modify the drug's labeling to reflect this risk. The Paxil birth defect risk is especially high if an expectant mother took Paxil during the first trimester of pregnancy.

If you or someone you know was the victim of Paxil side effects, we urge you to contact one of the Paxil injury lawyers at Parker Waichman LLP LLP by completing the form at right or call us at 1-800-YOURLAWYER(1-800-968-7529) as soon as possible.

Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the U.S., with more than 19.7 million prescriptions. Paxil was approved by the FDA to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was the first antidepressant formally approved in the U.S. for the treatment of social anxiety disorder.

Paxil is part of a class of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs). SSRIs affect serotonin levels in the brain, a chemical neurotransmitter. Serotonin is produced in the brain on an ongoing basis and, in a normally healthy system, is a response to pleasure-giving experiences. SSRIs like Paxil have been linked to an increased risk of suicide when they are taken by young people. In addition to investigating claims for Paxil birth defects, our Paxil injury lawyers are also offering free no-obligation case evaluations to victims of other Paxil side effects, including suicidal behavior, heart malformations, etc.

Paxil Birth Defects, Heart Malformation, FDA Warnings

In September 2005, the FDA and GlaxoSmithKline alerted doctors about a new study on major birth defects seen in babies born to women who took the antidepressant Paxil during the first trimester of pregnancy. The alert was based on a study GlaxoSmithKline conducted of major birth defects in infants born to women who took antidepressants including Paxil - during the first trimester of pregnancy.

In the study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA. Most of the birth defects seen in the study were heart related; the most common heart malformations were ventricular septal defects, which are holes between the heart's two main pumping chambers. The FDA said GlaxoSmithKline would be updating the Paxil precautions section to include data from this study.

In December 2005, the FDA announced that it was requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug's prescribing information. The FDA took the action because the early results of two more studies showed 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 atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects ranged in severity from those that were minor and resolved without treatment to those that caused serious symptoms and needed to be repaired surgically.

The FDA said in one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

The Paxil label was again changed to reflect the latest data from the two studies and to change the pregnancy category. The FDA had previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new Paxil labeling now classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

The FDA advised health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. The agency also said health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.

The FDA also cautioned patients that Paxil should usually not be taken during pregnancy. Women taking Paxil who were pregnant or planned to become pregnant were advised to talk to their physicians about the potential risks of taking the drug during pregnancy. However, the FDA also said women taking Paxil should not stop taking it without first talking with their physician.

Paxil Related Birth Defects, Heart Malformation Victims - Legal Help

If you know a child who has suffered from Paxil birth defects, or if you or someone you know experienced other serious side effects because of Paxil, we urge you to contact Parker Waichman LLP immediately. Our experienced Paxil side effects lawyers can make sure you or your loved one is compensated for your injuries. Please fill out our online form or call us at 1-800-YOURLAWYER (1-800-968-7529) for a free review of your case.



 

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Glaxo Reaches Record $3 Billion Settlement to Resolve Paxil, Wellbutrin and Avandia Fraud Charges

Jul 3, 2012 | Parker Waichman LLP
GlaxoSmithKline has agreed to pay a record settlement to resolve charges that it illegally marketed some of its drugs, including Paxil and Wellbutrin.  The $3 billion settlement with the U. S. Justice Department will also resolve charges that Glaxo failed to report important safety data to the U.S. Food & Drug Administration (FDA) about its diabetes drug Avandia.According to the Justice Department, the $3 billion Glaxo settlement constitutes the largest healthcare-fraud settlement in...

SSRI Antidepressant Patients Admitted to ICU Have Higher Death Rates

May 23, 2012 | Parker Waichman LLP
Yet another study is raising questions about the use of certain antidepressants, including selective serotonin reuptake inhibitor (SSRI) antidepressants.  This time, research indicates that ICU patients who took SSRI antidepressants prior to admission have a higher rate of mortality, both while in the hospital and during the year after their hospital stay."Major depression is a common disorder affecting more than 16 percent of adults in the United States, and SSRI's are the most commonly...

Study Points to Multiple Health Effects from SSRI Antidepressants

May 15, 2012 | Parker Waichman LLP
Another recent study has painted a grim picture on the safety and efficacy of popular antidepressant drugs like Prozac, Paxil, and Zoloft. According to a report from UK’s The Daily Mail, a new study published in the journal Frontiers of Evolutionary Psychology notes that more people are learning of the negative effects of selective serotonin reuptake inhibitor (SSRI) drugs than they are the intended benefits. SSRIs are often prescribed to treat mild and...

More Harm than Good from SSRI, Other Antidepressants, Study Finds

Apr 26, 2012 | Parker Waichman LLP
A group of Canadian researchers says the risks of antidepressants - including selective serotonin reuptake inhibitor (SSRI) antidepressants - outweigh their benefits.  In a study published in the journal Frontiers in Psychology, the researchers conclude that the antidepressants are probably doing more harm than good, and use of the drugs should be reconsidered.The study, a review previous research into the effects of antidepressants conducted by scientists at McMaster University in Canada,...

SSRI Antidepressants May Influence Fetal Head Development

Mar 6, 2012 | Parker Waichman LLP
A new study published this week online in the Archives of General Psychiatry has found a possible link between selective serotonin inhibitor (SSRI) antidepressants and small fetal head growth, as well as preterm birth.  The study, conducted by researchers at Sophia Children's Hospital and Erasmus Medical Center in Rotterdam, the Netherlands, is just the latest to provide evidence that using SSRI antidepressants, such as Prozac, Lexapro, Celexa, Paxil and Zoloft, during pregnancy, can...

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