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Paxil Birth Defect Lawyers

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The lawyers and attorneys at our firm are currently representing families of children who have suffered Paxil birth defects.  In 2005, the Food & Drug Administration (FDA) warned that the antidepressant Paxil had been linked to an increased risk of birth 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 our Paxil injury lawyers as soon as possible.

If you were taking PAXIL during your the first 3 months of your pregnancy and your child has a Club Foot Birth Defect or a Heart Defect, then fill out the Free Case Review Form (located just to the right) or call 800-LAW-INFO. There is No Cost To You.

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 US, 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 US for the treatment of social anxiety disorder.

 
Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).  SSRIs affect seratonin levels in the brain, a chemical neurotransmitter.  Seratonin is produced in the brain on an ongoing basis and in response to pleasure-giving experiences, in a normally healthy system. 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 evaluations to victims of other Paxil side effects, including suicidal behavior.

 
FDA Paxil Birth Defect 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.

 
Other Paxil Side Effects

Paxil has also been tied to other serious side effects, including suicide in young people and serious withdrawal symptoms.  The withdrawal symptoms have been seen in both Paxil patients and to babies born to women who took Paxil  during the third trimester of pregnancy.  Our Paxil side effect lawyers are currently offering free consultations to anyone who suffered these or other Paxil injuries.

In 2006, the FDA proposed expanding the labels of all antidepressants - including Paxil - to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age.  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.

The new suicide warning followed an analysis of multiple trials including 15,000 patients  that revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo.  Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.

Paxil has also been associated with difficult withdrawal side-effects. Paxil users often experienced these withdrawal effects just hours after a missed dose. SSRI antidepressants, including Paxil, Prozac and Zoloft, have also been linked to withdrawal symptoms in babies born to mothers taking these medications.  The Paxil web site says: "Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.  Like many antidepressants, Paxil can be present in breast milk so tell your doctor if you are nursing."

Legal Help for Victims of Paxil Side Effects

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 call our law firm 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 LAW INFO (1-800-529-4636) for a free review of your case.