Authors: Pennell PB and Meador KJ., Neurology 2016 Jun 14; 86:2224
Prospective cohort study raises concern about teratogenic potential of this neuropsychiatric medication.
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 683 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% of exposed women also received other antiepileptic medications. In analysis excluding genetic abnormalities, risk for major birth defects was not significantly higher among women who received pregabalin monotherapy (OR, 2.8; 95% CI, 0.3–23.2).
Although these findings raise concern about pregabalin’s potential for harm during early pregnancy, they are not definitive. As is often true when exploring effects of medications used for multiple indications, controlling for the underlying diseases and their severity is challenging. Notably, most participants discontinued pregabalin during the first trimester, suggesting that comprehensive preconception counseling — including appropriate, effective contraception — might have averted unplanned exposure.