Paxil FAQ

What is Paxil?

Paxil, made and sold by GlaxoSmithKline, was approved by the Food and Drug Administration in 1992. It is a drug that is meant to help relieve the symptoms of depression, anxiety and obsessive-compulsive disorders. Paxil is among a group of drugs known as selective serotonin reuptake inhibitors (SSRIs), which increase the level of serotonin in a person’s brain. Paxil is marketed as Seroxat in Europe.

Are there any side effects associated with Paxil?

The Food and Drug Administration has warned that women who take Paxil during the first trimester of pregnancy are twice as likely to give birth to a child with congenital birth defects, including atrial septal defects and ventral septal defects. The agency has also warned that children born to women who take antidepressants such as Paxil late in pregnancy are six times more likely to develop persistent pulmonary hypertension of the newborn (PPHN).

Are there any other congenital heart defects associated with Paxil during pregnancy?

In addition to ASD, VSD and PPHN, taking Paxil while pregnant may cause other serious heart defects, including cardiomyopathy, craniosynostosis, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), patent ductus arteriosus, bicuspid aortic valve, tricuspid stenosis and cleft mitral valve.

Have any Paxil birth defects lawsuits been filed?

Hundreds of families whose children were born with congenital heart defects or other birth defects have filed Paxil lawsuits against the drug’s manufacturer, GlaxoSmithKline. The company paid more than $1 billion in 2010 to settle nearly 200 lawsuits over Paxil birth defects. At the time, more than 600 addition birth defects lawsuits remained pending against the company.

Will the FDA or GSK issue a Paxil recall?

In March 2005, GSK recalled several lots of Paxil CR due to violations of FDA-approved manufacturing practices. But despite multiple studies warning about the side effects of Paxil, neither the FDA nor GSK have announced plans to recall the antidepressant from sale in the U.S. due to its risk of causing birth defects or other health issues.

What should I do if I think I have been injured as a result of taking Paxil?

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions related to Paxil use, you should first contact a doctor. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Paxil use. Many Paxil lawsuits have been filed in the last two years.

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