Archive for the ‘Drug Effects: Criminal or Civil?’ Category

Paxil and the Risk of Heart Defects: FDA Advisement

Saturday, January 30th, 2010

FDA Has Advised: Risk of Heart Defects with Paxil

Paxil has been linked to numerous birth defects. Heart defects including atrial and ventricular septal defects have been linked with Paxil use during the first trimester of pregnancy. According to two studies, women who took the antidepressant Paxil during their first trimester of pregnancy were one and a half to two times more likely to have a baby born with a heart defect than women on other antidepressants or women in the general population. These studies reported mostly atrial and ventricular septal defects, which are holes in heart’s chamber walls. The right and left atria are separated from each other by a septum; one side contains oxygen-rich blood and the other oxygen-poor blood, and the septum keeps these chambers separate. A defect in the septum may need to be repaired surgically and can be life threatening.

Other Paxil Birth Defects

  • Atrial and Ventricular Septal Defects
  • Lung Disorder
  • Persistent Pulmonary Hypertension of the Newborn

Lung Disorder (PPHN) Linked to Paxil in Pregnancy

Studies have shown an increase in the risk of a lung disordered called Persistent Pulmonary Hypertension of the Newborn (PPHN) in babies whose mothers took Paxil during the second half of pregnancy. In utero, a baby does not need to use its lungs and therefore has a special fetal blood vessel, the ductus arteriosus, which carries blood from the pulmonary artery back to the heart, bypassing the lungs. In normal infants at birth, the ductus arteriosus closes as normal breathing begins, and oxygen-rich blood goes to the heart to be circulated throughout the body. However, in babies with Persistent Pulmonary Hypertension of the Newborn, the ductus arteriosus stays open. As a result, the blood bypasses the lungs, as before birth, and oxygen-poor blood circulates throughout the body to its organs. Signs of PPHN after birth include fast breathing and heart rate, blue skin, and problems breathing. PPHN is serious; infants may require mechanical breathing assistance. Some will die after birth and some will develop brain abnormalities and hearing problems.