This article originally posted 24 October, 2006 and appeared in Issue 335
Metformin Exposure During First Trimester Seen Safe for Fetus
Metformin taken by women with polycystic ovary syndrome (PCOS) during the first trimester of pregnancy does not appear to increase the risk of major fetal malformations, and may have a significant protective effect.
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Metformin is used for the treatment of infertility in women with PCOS, yet
the safety of the biguanide for the fetus has not been established, Dr. Gideon
Koren of The Hospital for Sick Children in Toronto, Ontario, and colleagues
point out. The other biguanide, phenformin, has been shown to be teratogenic.
Dr. Koren and colleagues conducted a meta-analysis of eight randomized, controlled
studies of metformin taken during the first trimester of pregnancy by a total
of nearly 500 women with either PCOS or diabetes.
From the pooled data, the malformation rate in the treatment group was 1.7%
compared with 7.2% in disease-matched controls who did not receive metformin.
The researchers found that "after adjustment for publication bias, metformin
was associated with a statistically significant protective effect of 57%"
against major malformations in the fetus.
In their paper, the investigators caution that the data establishing safety
of metformin in pregnancy is still limited. This study considered only major
malformations of the fetus. Other studies assessing the incidence of spontaneous
abortion, stillbirth, minor abnormalities, intrauterine growth retardation and
preterm labor still need to be conducted.
Fertil Steril 2006;86:658-663.
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