FDA issues warning on treatment of depressed mothers-to-be

July 24, 2006

Results from two recent studies have led the FDA to notify healthcare professionals and consumers to new concerns about treating pregnant women who take antidepressants. One study showed that women who stopped taking their antidepressants were five times more likely to experience a relapse of their depression during pregnancy compared with those who continued to take the medication.

FDA issues warning on treatment of depressed mothers-to-be

Results from two recent studies have led the FDA to notify healthcare professionals and consumers to new concerns about treating pregnant women who take antidepressants. One study showed that women who stopped taking their antidepressants were five times more likely to experience a relapse of their depression during pregnancy compared with those who continued to take the medication. However, a second study revealed the incidence of persistent pulmonary hypertension in infants born to mothers who took an SSRI after the 20th week of pregnancy was six times greater than in infants whose mothers did not take an SSRI. The FDA also noted that the labeling for paroxetine was recently changed to include information from a study that found exposure to the drug during the first trimester of pregnancy may be associated with cardiac birth defects. The agency has asked all manufacturers of SSRIs to update their prescribing information to describe the potential risk for pulmonary hypertension in infants while they seek additional data regarding this risk.

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