NEW YORK (Reuters Health) – Women with pregestational diabetes who are taking metformin are at increased risk for poor pregnancy outcomes, new findings show.
But because women taking metformin for other indications were not at increased risk, the association seems to be due to the underlying disease rather than the drug itself, Dr. Alice Panchaud of Harvard School of Public Health in Boston and colleagues conclude in their report, online December 20.
While metformin may be used to treat gestational diabetes, few studies have looked at the drug’s safety in early pregnancy, Dr. Panchaud and her team note.
They compared 471 pregnant women exposed to metformin and 479 who were not exposed during pregnancy. Nearly two-thirds of women on metformin were taking it for pre-gestational diabetes. Most (97%) of the metformin group started the medication before getting pregnant, and 73% stopped taking the drug during their first trimester.
Major birth defects (MBD) without a chromosomal or genetic origin occurred in 5.1% of the metformin-exposed pregnancies and 2.1% of the reference group (adjusted odds ratio, 1.70; 95% confidence interval, 0.70-4.38).
For women without pregestational diabetes who were exposed to metformin, the risk of MBD was 1.7%, versus 7.8% for those with pregestational diabetes. The odds of MBD did not differ significantly between nondiabetic patients on metformin and the unexposed reference group, but were 3.95 times higher for those with diabetes (95% CI, 1.8-9.4).
Twenty-one percent of the metformin-exposed women lost their pregnancies, versus 10.8% of the reference group. The adjusted hazard ratio for pregnancy loss with metformin exposure was 1.57 (95% CI, 0.90-2.74). Among the exposed group, 24.0% of those with pregestational diabetes lost their pregnancy (HR, 2.51; 95% CI, 1.44-4.36), versus 16.8% of those taking metformin for other indications (HR, 1.38; 95% CI, 0.74-2.59).
“Pregnant women with pregestational diabetes on metformin are at an increased risk of mutiple adverse pregnancy outcomes,” the researchers write. “However, this risk appears to be due to the underlying diabetes, with no indication of a teratogenic or abortifacient effect of metformin. Future studies comparing metformin exposed pregnancies with women with the same indication and treated with alternative therapies, e.g., on insulin are warranted.”
SOURCE: http://bit.ly/2AhbpBB
Br J Clin Pharmacol 2017.
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