FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy.
The early results of two studies showed that zofran birth defects facts women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population.
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. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. Women taking Paxil should not stop taking it without first talking with their physician. 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. 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).
FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate. Women taking Paxil who are pregnant or plan to become pregnant should talk to http://www.goodrx.com/zofran their physicians about the potential risks of taking the drug during pregnancy. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. 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