by Josephine Osborn
The US Food and Drug Administration (FDA) has warned both health care service providers and their patients about the side effects of paroxetine antidepressant Paxil. Studies suggested that Paxil increases the risk of birth defects on infants of mothers who used it during the first three months of gestation. These birth defects may come in the form of physical deformities such as irregular head sizes, cardiovascular complications or mental disorders such as autism.
The FDA likewise issued a "black box" warning for contraindications of Paxil which included suicidal behavior among adolescent users and cardiovascular complications. Birth defects, however, are the most complained about side effect of Paxil intake which has been the subject of various lawsuits against is manufacturer GlaxoSmithKline. Most of the heart defects reported among infants in these studies were atrial and ventricular septal defects, which prompted the FDA to change Paxil's pregnancy warning category from C to D.
According to the University of Maryland Medical Center (UMMC), ventricular septal defect describes one or more holes in the wall that separates the right and left ventricles of the heart. Ventricular septal defect is one of the most common congenital heart defects, which is often present upon birth. The infant may show no symptoms, and the hole may eventually close as the wall continues to grow after birth. However, if the hole is large, too much blood will be pumped to the lungs, leading to heart failure, says the UMMC.
The American Heart Association also says that if the opening is large, the child may breathe faster and harder than normal. Infants may have trouble feeding and growing at a normal rate. Over time, this may cause permanent damage to the lung blood vessels of the infant because more blood than normal is being pumped there. According to the Cedars-Sinai Heart Institute, heart failure may be regulated through heart stimulating drugs which will eventually help the child grow naturally. However, Cedars-Sinai adds that if the baby does not respond to treatment, surgery may be necessary to repair the defect.
The FDA has already verified some complaints that associated Paxil to ventricular septal defect. Other cardiovascular complications that constitute Paxil birth defects are persistent pulmonary hypertension on newborns, congenital central hypoventilation syndrome and hypoplasia. Although, more studies are required to substantiate these claims, the link between Paxil and the aforementioned birth defects are increasingly becoming clear, warranting more interest and concern.