Paxil Lawsuit And Birth Defect Information
In recent years, serious and potentially-fatal birth defects resulting from treatment with Paxil (paroxetine) during pregnancy have prompted thousands of women to file lawsuits against GlaxoSmithKline (formerly SmithKline Beecham), the manufacturer of Paxil. The company could face billions of dollars in damages based on the drug’s potential to cause birth defects, most notably serious and potentially-fatal heart defects, if taken during the first trimester of pregnancy.
Can Paxil Cause Birth Defects?
Studies indicate that 4 percent of women taking Paxil during pregnancy gave birth to babies with congenital birth defects, as compared with 2 percent of women taking other antidepressants during pregnancy.Many women that took Paxil were not warned of the risks associated with Paxil, namely that the medication nearly doubles the risk of having a baby born with a heart defect.
If you were prescribed Paxil during pregnancy and experienced pregnancy complications that may be related to the use of antidepressant medications you may be eligible for compensation. If you want to learn more about paxil lawsuits and your legal options please call 1-800-452-0949 or fill out the form on this page.
Did GlaxoSmithKline Properly Warn Patients of the Pregnancy Risk?
First introduced in 1992 as a pregnancy category C drug, Paxil was not medically evaluated for its potential to cause birth defects until 2005, when the FDA demanded that the drug be reviewed for its teratogenic potential. GlaxoSmithKline and the FDA announced updated warning labels for Paxil in 2005 when a series of studies showed a connection between fetal Paxil exposure during the first trimester of pregnancy and an increased risk of serious birth defects such as persistent pulmonary hypertension of the newborn (PPHN) and other potentially-fatal heart defects.
Millions of women may have taken Paxil during pregnancy in the years before the warning labels on Paxil were strengthened, which may have placed many unborn children at risk of severe and life threatening birth defects.
What Risks are Associated with Paxil?
Numerous clinical studies in recent years have noted an increased risk of birth defects in newborns born to mothers who used paroxetine (Paxil) during pregnancy, especially during the first trimester of development. Birth defects linked to Paxil use during pregnancy include:
- Hypoplastic left/right heart syndrome
- Congenital heart defects
- Cleft lip and cleft palate
- Clubfoot
- Brain defects such as anencephaly
- Neural tube defects such as spina bifida
- Persistent pulmonary hypertension of the newborn (PPHN)
- Atrial or ventricle septal defects (holes in the heart wall)
A study conducted using data from a Swedish national pregnancy registry determined that women who took Paxil during early pregnancy experienced a 2-fold increase in risk of having a baby born with heart defects when compared with the national average. The risk of birth defects may be even higher, as study data may not include the number of still births, abortions or miscarriages due to birth defects caused by Paxil.
Paxil-related birth defects and other complications may also occur in babies born to mothers who have taken antidepressants during the third trimester of pregnancy. According to warning labels for Paxil, some babies exposed to Paxil and other SSRIs late in the third trimester “have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding,” with reports of breathing difficulties, apnea, vomiting, seizures, feeding difficulties, irritability, tremor and constant crying. Premature births have also been reported in pregnant women exposed to SSRIs such as Paxil.
How Can I File a Paxil Lawsuit?
If your child was born with birth defects as a result of exposure to Paxil or other SSRI antidepressant medications during pregnancy, it is important to speak with a lawyer as soon as possible to begin constructing your case against GlaxoSmithKline. It is believed that the company may have known about the serious risks associated with Paxil many years prior to the updated warning label, but the company continued to market the drug to women of childbearing age despite this risk.
