Suit Blames Paxil for Birth Defects

A Louisiana couple claims that Glaxo SmithKline's Paxil, taken by the mother during pregnancy, caused their child's birth defects, including a club foot and other congenital defects and disorders.

In the case, being heard in federal court in Lake Charles, La., Russell and Desiree Figueroa say they did not discover that the injuries to their son, Joseph, were caused by Desiree's use of Paxil until years after their son's birth on Nov. 12, 2003.

They allege that Glaxo SmithKline concealed information about the possible harmful effects of taking Paxil during pregnancy.

The U.S. Food and Drug Administration (FDA) and Glaxo did not issue a warning about the risk of birth defects from Paxil use until September 2005, when they issued a news release noting that that a study had identified a risk of major congenital malformations in infants born to women taking Paxil and Paxil CR during the first trimester of pregnancy.

"Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA said.

Desiree Figueroa says in the suit that she took Paxil as prescribed by her physician for treatment of depression. Glaxo SmithKline had not issued any warnings about using the drug during pregnancy and she argues she would not have taken the drug had she been properly advised of the risks associated with it.

The suit argues that because Paxil crosses the placenta, it is “unreasonably dangerous in design” and seeks damages and legal fees.