On September 27, 2005 the United States Food and Drug Administration (FDA) released the results of a study which showed that Paxil has the potential to cause major birth defects in newborns whose mothers took Paxil during the first trimester of pregnancy.  The FDA made a public statement with regards to the study which stated: "Healthcare professionals are advised to carefully weigh the potential risks and benefits of using Paxil in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients."

In response to the FDA study the manufacturer of Paxil, GlaxoSmithKline (GSK), has updated warning labels on their product.GSK also placed a warning about Paxil on their website after the study’s publication, this warning states: "Tell your doctor if you are pregnant or plan to become pregnant as there is a potential risk to the fetus with [Paxil]. Some studies of [Paxil] in pregnant women have suggested a possible increased risk of malformations, while others have not shown such a risk."

Concerning the possible birth defects that Paxil can cause GSK has placed a statement on its website as well this statement says: "Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.”

A study concerning Paxil and the major birth defects in newborns it can possible cause especially in mothers have taken the drug during pregnancy, has been released by the FDA. The FDA study has also caused the manufacturer of Paxil, GlaxoSmithKline, to change warnings on both its website and product. If your child has been born with a major birth defect and you believe that your consumption of Paxil during pregnancy is the cause, then taking legal action could be your next logical step.For more information on any potential legal action you may take, visit with a Paxil  lawyer as soon as possible, most lawyers will give you a free consultation and many will not charge you unless your case receives compensation by the courts.