A new warning from the FDA and this one involves women taking Paxil. Two new studies show women taking Paxil during the first three months of pregnancy were one and half to two times more likely to have a baby with a heart defect. So, the FDA is advising doctors and patients now to discuss that risk for women before taking that antidepressant.
The FDA has asked the drug maker, Glaxo Smith Kline, to add a stronger warning about pregnancy complications to the label. The risk for having a baby with heart defects in the general population is one in one-hundred. GSK is now updating the warning label. According to the FDA statement: "Most of the heart defects reported in these studies were atrial and ventricular septal defects, holes in the walls of the chambers of the heart. In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically." According to the FDA statement: "In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population.
In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy."