Paxil is a widely used antidepressant belonging to a class of drugs called Selective Serotonin Reuptake Inhibitors [SSRI]. It works to improve mood related conditions by restoring the natural balance of a brain chemical called serotonin. The Food and Drug Administration approved Paxil, which is manufactured by Glaxo SmithKline, for use in 1992 for the treatment of depression.
Studies that Confirm Paxil Birth Injuries
In 2005, two separate studies conducted by American and Swedish researchers revealed an increased risk of heart defects in babies born to pregnant women who took Paxil during the first 3 months of pregnancy. The American findings showed a 1.5% higher risk of heart related birth defects in women who took the drug versus those who did not. The Swedish studies placed the risk of heart related birth defects at 2% higher. In 2006, the New England Journal of Medicine published its studies which found a high risk of a condition called Persistent Pulmonary Hypertension of the Newborn or PPHN. According to the study, women who took Paxil at or after the 20th week of pregnancy were likely to have babies that were at least 6 times more at risk for PPHN, than babies whose mothers were not on an antidepressant.
Paxil Side Effects
Beside this study, several reports have emerged of heart, lung and brain defects resulting from the use of Paxil during pregnancy. These babies have been found to have an increased risk of the development of PPHN which impacts the heart and lungs. PPHN is a potentially life treating condition that occurs soon after birth. Babies who suffer from PPHN develop high pressure in the blood vessels of their lungs, and as a result, oxygen supply into the blood stream is interrupted. The lack of blood means a decreased supply of oxygen resulting in organ damage, kidney failure, heart failure, and brain hemorrhage. Babies who suffer from PPHN require emergency treatment and even then, death may occur. Even when babies survive PPHN, they may continue to suffer from long-term effects of the disorder like respiratory difficulties, delayed developmental milestones caused by damage to the brain, neurological disorders, seizures and speech and hearing problems.
The use of Paxil during pregnancy can also cause a condition called Craniosynostosis in which there is a premature fusion of the cranial sutures that can give the head an abnormal shape. Paxil use has also been linked to a congenital malformation in which there is a protrusion of the baby's abdominal organs including the intestine, out of the navel. Babies have also been found to develop a defect of the central nervous system leading to a condition called Anencephaly. Here, there may be a partial or complete lack of the cerebrum, resulting in underdevelopment of the brain.
Paxil has been a top selling drug for Glaxo SmithKline with over 25 million prescriptions written in 2000 alone. In 2003, the company sponsored a study that suggested Paxil used during pregnancy increased the risk of birth defects by two fold. This didn’t stop the company from continuing to market it as a category C drug, which means that although adverse effects from the drug have been seen in animal fetuses, there are no reliable studies conducted on humans. In 2005, Glaxo was asked to strengthen their warnings on Paxil and categorize it as a pregnancy category D drug which means that there is evidence of risk to fetuses if it is used during pregnancy.
Paxil and You
Glaxo continues to promote Paxil for use during pregnancy, claming that there is a high risk of depression relapse in patients who stop taking the medication during pregnancy. The FDA has made stronger warning labels a requirement and has issued an advisory, informing doctors of the high risk of birth defects.