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Migraines, Triptan Safety, and Pregnancy

by Teri Robert, Lead Expert

Treating Migraines during a pregnancy has been a big problem for many women. All of the current Migraine abortives are FDA pregnancy C, which means one of two things:

  1. animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women - or -
  2. animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.

The manufacturer of Imitrex (sumatriptan, now available as generic) and Amerge (naratriptan), GlaxoSmithKline, has been monitoring any effects on children whose mothers took Imitrex or Amerge during pregnancy. They've tracked this with the Sumatriptan and Naratriptan Pergnancy Registry. Healthcare professionals from anywhere in the world can enroll, on a voluntary basis, women exposed to sumatriptan or naratriptan during their pregnancies in this primarily prospective, observational study.

Researchers have been reviewing the data in this registry, using the data to study whether sumatriptan and naratriptan, taken during pregnancy, caused birth defects.

Study results:

There is data available on pregnancy outcomes from 599 women.

  • Of 479 exposures to sumatriptan during the first trimester, 20 reports of major birth defects, one fetal death, and three induced abortions.
  • Of 63 infant and fetus exposures to sumatriptan during the second trimester, there were three reports of major birth defects.
  • Of 12 infant and fetus exposures to sumatriptan during the third trimester, there were no reports of birth defects.
  • There were 50 exposures to naratriptan during the first trimester with one reported major birth defect and one induced abortion.
  • There were five exposures to naratriptan during the second trimester with no reported birth defects.
  • There were seven exposures to both sumatriptan and naratriptan during the first trimester.
  • One child was born with major birth defects after the other took both sumatriptan and naratriptan.
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