B Källén1, P E Lygner. 1. Tornblad Institute, University of Lund, Sweden; Glaxo Wellcome AB, Mölndal, Sweden.
Abstract
OBJECTIVE: To evaluate delivery outcome in women who used drugs for migraine during pregnancy with special reference to sumatriptan. BACKGROUND: The safety of the use of drugs for migraine during pregnancy is not established. DESIGN AND METHODS: Using the Swedish Medical Birth Registry which contains information on drug use reported by women at the first antenatal visit, 912 infants (born in 905 deliveries) whose mothers had used drugs for migraine were identified, the majority of whom (n = 658) had used sumatriptan. RESULTS: These women differed from the general population of women who had delivered by being older and more often of first parity, but they had similar smoking habits. Slightly more often, the infants were preterm, and they had a birth weight less than 2500 g; neither of these effects were statistically significant. There seemed to be no difference between infants exposed to sumatriptan and those exposed to other drugs used for migraine. No increase in the rate of congenital malformations was seen. CONCLUSIONS: The data indicate that use of sumatriptan in early pregnancy does not result in a large increase in teratogenic risk, but do not rule out the possibility of a moderate increase in risk for a specific birth defect.
OBJECTIVE: To evaluate delivery outcome in women who used drugs for migraine during pregnancy with special reference to sumatriptan. BACKGROUND: The safety of the use of drugs for migraine during pregnancy is not established. DESIGN AND METHODS: Using the Swedish Medical Birth Registry which contains information on drug use reported by women at the first antenatal visit, 912 infants (born in 905 deliveries) whose mothers had used drugs for migraine were identified, the majority of whom (n = 658) had used sumatriptan. RESULTS: These women differed from the general population of women who had delivered by being older and more often of first parity, but they had similar smoking habits. Slightly more often, the infants were preterm, and they had a birth weight less than 2500 g; neither of these effects were statistically significant. There seemed to be no difference between infants exposed to sumatriptan and those exposed to other drugs used for migraine. No increase in the rate of congenital malformations was seen. CONCLUSIONS: The data indicate that use of sumatriptan in early pregnancy does not result in a large increase in teratogenic risk, but do not rule out the possibility of a moderate increase in risk for a specific birth defect.
Authors: Jørn Olsen; Andrew Czeizel; Henrik Toft Sørensen; Gunnar Lauge Nielsen; Lolkje T W de Jong van den Berg; Lorentz M Irgens; Charlotte Olesen; Lars Pedersen; Helle Larsen; Rolv T Lie; Corinne S de Vries; Ulf Bergman Journal: Drug Saf Date: 2002 Impact factor: 5.606