According to Drug Alert, the FDA has issued a warning about Paxil, as it may put fetuses at risk for birth defects. A study conducted in 2005 by drug giant, GlaxoSmithKline PLC was recently reviewed by the FDA, who warns the medication could cause a range of birth defects in children. The data collected from over 3,500 who took Paxil during the first three months of pregnancy has caused the FDA to change its warning label from Class C to a more serious Class D, meaning there is evidence the drug poses a risk to unborn children. The FDA recommends that pregnant women do not take Paxil unless the benefits for the mother outweigh the risk posed to the fetus.
The FDA warned health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to get pregnant or are in the first trimester of pregnancy, which is when birth defects most commonly develop. Healthcare professionals should consider discontinuing Paxil to women who are pregnant or plan to become pregnant, and switch them to an antidepressant not associated with the risks of birth defects.
According to research found, women taking Paxil during the first trimester of pregnancy were almost twice as likely to have a baby with atrial or ventricular birth defects. The defect is known as a septal malformation, where holes form between the two chambers of the heart. In some cases, the defect can repair itself with age, although some instances require surgery.
