A Houston area woman has filed a lawsuit against against GlaxoSmithKline a London based company that manufactures the drug Paxil for depression. The suit contends that GlaxoSmithKline withheld pertinent information about the potential risk of the drug Paxil for pregnant women and their unborn children.
The Plaintiff in this case was prescribed Paxil six months before she became pregnant for treatment of her irritable bowel syndrome and sometimes feeling claustrophobic. Once she became pregnant asked her primary care physician if Paxil was safe to continue taking while pregnant, her physician assured her that it was safe. A test done during her pregnancy confirmed that her unborn son had an underdeveloped heart chamber and he would have to have immediate surgery after his birth. After extensive surgeries the child is still living. The association of Paxil and her son’s illness was not made until she saw a news segment about the potential risk of antidepressants and congenital heart defects.
The FDA has now issued three public health advisories since December 2005 regarding the threat of Paxil and the congenital heart defects.
It will be interesting to see what will become of these of these cases. There are many questions to be answered. Do other antidepressants cause the same heart defects in unborn children? How long were the mothers taking the drug? Exactly what information did the manufacture hide? The most frightening question is how many unborn/newborn children were affected by the drug company(ies) negligence.