Paroxetine and Birth Defects
The FDA has alerted health care professionals and patients that paroxetine (Generic Paxil, GlaxoSmithKline) might increase the risk of birth defects, particularly heart defects, for women taking it during the first trimester of pregnancy. Paroxetine is approved for the treatment of depression and other psychiatric disorders.
The FDA is advising health care professionals to discuss the potential risk of birth defects with patients who plan to become pregnant or who are in their first three months of pregnancy. Health care professionals should consider discontinuing the agent and prescribing another antidepressant if indicated.
In some patients, the benefits of continuing therapy with drug paroxetine may be greater than the potential risk to the fetus.
Early results of two studies showed that women who taking medication paroxetine during the first trimester were about 1.5 to two times as likely to have a baby with a heart defect as women taking other anti-depressants or women in the general population. Most of the heart problems were atrial and ventricular septal defects.
The FDA has asked the manufacturer to change the pregnancy category from C to D, which carries a stronger warning.
