Pregnant Women: Reproduction studies, performed in rats, have not revealed any evidence of impaired fertility, teratogenicity, or postnatal development due to sumatriptan succinate. Reproduction studies, performed in rabbits by the oral route, have shown increased incidence of variations in cervico-thoracic blood vessel configuration in the fetuses. These effects were only seen at the highest dose tested, which affected weight gain in the dams, and at which blood levels were in excess of 50 times those seen in humans after therapeutic doses. A direct association with sumatriptan succinate treatment is considered unlikely but cannot be excluded.
Post-marketing data from multiple prospective pregnancy registries have documented the pregnancy outcomes in approximately 1,100 women exposed to sumatriptan. At this time, there is insufficient information to draw conclusions. Therefore, the use of pms-SUMATRIPTAN is not recommended in pregnancy and it should be used only if the potential benefit to the mother justifies the potential risk to the fetus.
In a rat fertility study, oral doses of sumatriptan succinate resulting in plasma levels approximately 150 times those seen in humans after a 6 mg subcutaneous dose and approximately 200 times those seen in humans after a 100 mg oral dose were associated with a reduction in the success of insemination. This effect did not occur during a subcutaneous study, where maximum plasma levels achieved approximately 100 times those in humans by the subcutaneous route and approximately 150 times those in humans by the oral route.
Nursing Women: Sumatriptan is excreted in human breast milk. Therefore, caution is advised when administering pms-SUMATRIPTAN to nursing women. Infant exposure can be minimized by avoiding breast-feeding for 24 hours after treatment.