FDA Study Causes Change on Paxil Labeling and GSK website
FDA Study Causes Change on Paxil Labeling and GSK website
A study published by the United States Food and Drug Administration on September 27, 2005 showed that Paxil has the potential to cause major birth defects in newborns whose mothers took Paxil during the first trimester of pregnancy. With regards to the publishing of the study the FDA made this statement: "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.The GSK website got an update as well after the study, these warnings advise their customers: "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."
Also with concerns about birth defects that Paxil can cause the GSK website states: "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 has been released by the FDA concerning Paxil and the potential the drug has to cause major birth defects in newborns whose mothers have taken it during pregnancy. The FDA study has also caused the manufacturer of Paxil, GlaxoSmithKline, to change warnings on both its website and product. If you or someone you know has been harmed in anyway because of the consumption of Paxil during your pregnancy then knowing your legal options could be your next 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.
