Missouri Paxil Birth Defects Attorneys
Paxil
GlaxoSmithKline first placed Paxil on the market in 1992. By 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US. Paxil was approved by the FDA to treat many psychological issues including depression, OCD, post-traumatic stress disorder (PTSD), panic disorder, anxiety disorder, social phobia, and premenstrual dysphoric disorder (PMDD).
Paxil (paroxetine) affects the serotonin levels in the brain. Seratonin is produced by the brain in response to pleasure-giving experiences. When taken by young people, Paxil can lead to an increased risk of suicide. In addition, Paxil can be dangerous when taken by pregnant women as it has been linked to birth defects including persistent pulmonary hypertension as well as cardiac defects. The Paxil birth defect risk is especially high if an expectant mother took Paxil during the first trimester of pregnancy.
In September 2005, the FDA urged GlaxoSmithKline to educate 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 study of more than 3,500 pregnant women revealed that Paxil was linked to twice as many major birth defects as other antidepressants. Most of the birth defects seen in the study were heart related; the most common heart malformations were ventricular septal defects (holes between the pumping chambers).
In light of this study, in December 2005, the FDA required GlaxoSmithKline to add additional warnings about Paxil birth defects. A second study revealed further dangers from Paxil use during pregnancy. The label was again changed to reflect the latest data from the two studies and to change the pregnancy category. While the FDA previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out), it is now classified as Category D (Positive Evidence of Fetal Risk).
If your child suffered from birth defects due to the use of Paxil, contact the skilled Missouri pharmaceutical liability attorneys at Page Law for a free, no-obligation case evaluation.
