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Date you started taking this drug:

Date you stopped taking this drug:

Age of patient when antidepressant(s) prescribed:

What condition was this medication prescribed to treat?

What additional medications were you taking at the time?

Did patient hurt themselves during or after taking the drug?

Did patient become violent during or after taking the drug?

Was suicide attempted?

Was hospitalization or institutionalization required after taking antidepressant(s)?

Did loved one commit suicide?

If patient did attempt or commit suicide, did patient ever attempt suicide previously?

If patient did commit suicide, what was the method of suicide?

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If you ever tried to stop taking Paxil and experienced withdrawal, please describe the withdrawal side effects:

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paxil side effects, birth defects lawsuit

Paxil Side Effects Lawsuits; Birth Defects & Heart Defects, Malformation

Paxil Side Effects: Birth Defects, Heart Defects | Potential Lawsuits | Craniosynstosis, Limb Defects, Clubfoot, Spina Bifida

Paxil Side Effects Information & Facts

News Article Paxil and other SSRI's may be causing birth defects.

Selective Serotonin Reuptake Inhibitor (SSRI) use may Increase Risk of Septal Defects

in July 2011, the Obstetrics & Gynecology Journal suggested the use of certain SSRI medications, specifically Fluoxetine (Prozac) and Paroxetine (Paxil), taken during pregnancy can increase the risk of certain heart defects.

Paxil Birth Defects Warnings

The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects. The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a Category D from a Category C drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester showed that their babies have heart defects at a rate of 1.5 to 2 times the norm. The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.

If you have taken Paxil, and have given birth to a child with a birth defect the defective drug may be to blame. Below is a list of potential birth defects that have been linked to the use of Paxil:

  • Congenital heart lesions & anomalies
  • Down's syndrome
  • Undescended testes in males
  • Blindness
  • Spina bifida
  • Hernia
  • Malformations
  • Clubfoot (one or both feet turn downward and inward)
  • Septal defects; Cleft lip and/or cleft palate

Women who are pregnant and take SSRI antidepressants may face a greater chance of having a child with a birth defect. In 2005, a Danish study showed that infants exposed to SSRIs during the first trimester of pregnancy had a 60% higher probability of developing congenital heart defects when compared with infants whose mothers did not take the drugs. In 2006, the U.S. Food & Drug Administration (FDA) asked the manufacturers of several SSRI antidepressants to add information to their labels describing the potential risk of persistent pulmonary hypertension of the newborn (PPHN) after a study in the New England Journal of Medicine found a six-fold increased risk of the disorder among infants born to mothers who took an antidepressant in the later months of pregnancy. Other birth defects that may be linked to SSRI antidepressants include: ventricular outflow defects, hypoplastic left heart syndrome (HLHS), neural tube defects such as spina bifida, craniosynostosis (skull defect), infant omphalocele (abdominal wall defects), clubfoot, atrial and ventricular septal defects, cleft lip and cleft palate, and limb defects.

Antidepressant FDA Warnings, Suicidal Behavior Risk

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky and proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug's label to reflect that risk.

New Paxil Suicide Side Effects Warning

Paxil (Generic: Paroxetine hci) has been linked with suicide, suicidal ideation and violence in children and teenagers. On May 12, 2006, the FDA issued a Paxil warning when results of a study became public showing that Paxil also increases suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the pacebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30. Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder. An estimated 17 million people worldwide have been treated with Paxil.

In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. This follows a report issued by Britain's Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. British health regulators recently issued a warning and stated: It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks."  Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland, and the FDA continues to investigate the suicide risk associated with Paxil and other antidepressants.

Paxil Withdrawal Symptoms

Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. Recently, The British drug agency required Glaxo to remove a statement on its patient label saying that the drug was not addictive. Often these withdrawal effects are experienced just hours after a missed dose. Paxil withdrawal symptoms include a flu-like symptoms, anxiety, dizziness, fatigue, headache, migraine-like feelings, nerves jangling when moving eyes, continuous indigestion, neck and back pain, psychotic features such as visual and/or audio hallucinations/illusions, insomnia, nausea, restlessness, electrical shock phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colors & stressors, tremors, tinnitus and a vertiginous-like experience, depressive thoughts, suicidal thoughts, homicidal thoughts, extreme anger, severe agitation, extreme irritability, over-reacting, ringing in ears and throbbing in head, vomiting, paranoia, aggressive behavior, roller-coaster emotions, out of character behavior, severe malaise, general dysphoria, derealization and panic attacks.

In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.

During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.

Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

Paxil Victims - Legal Help

If you or a loved one took Paxil or other antidepressants and suffered any of the side effects mentioned here, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney at Parker Waichman LLP or call us at 1-800-YOURLAWYER (1-800-968-7529).


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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