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Pregabalin is used on- and off-label for various neuropsychiatric conditions (e.g., seizure disorder, neuropathic pain, restless leg syndrome). Researchers sought to determine risk associated with pregabalin use during early pregnancy. A cohort of 820 women were followed using data from an international teratology reporting service; 164 who received pregabalin were matched by age (but not medical condition) with 656 unexposed women.
Among women using pregabalin, first-trimester exposure occurred in 96%; therapy was discontinued at a median 6 weeks' gestation. Women who received pregabalin were more likely to have fetuses with major birth defects than unexposed women (6.0% vs. 2.1%; odds ratio, 3.0, 95% confidence interval, 1.2–7.9). Some 13%…