MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.
A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration and the manufacturer, referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.
Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society. And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).
Since then, however, Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately. The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.
The cohort studies included 66,409 women. The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls. The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.
“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.
“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”
The investigators, disclosed that they had no conflicts of interest related to their presentation.