Paxil Side Effects Victim 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.