my personal edition > migraine > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Registry Suggests Migraine Drug Sumatriptan May Be Safe During Pregnancy: Presented at IHC

By Larry Schuster

ROME, ITALY -- September 17, 2003 -- There appears to be no increased risk of defects for pregnant women who are exposed to sumatriptan, according to a review of a 7-year old international registry sponsored by GlaxoSmithKline.

Shashidhar H. Kori, MD, director, Imitrex Clinical Development & Medical Affairs, North Carolina, United States, reported on the results of 376 pregnancy outcomes, including 334 cases of first trimester exposures to sumatriptan. Of those first trimester exposures, birth defects were reported in 10 live births, 1 stillbirth and 1 induced abortion. No defects were reported in 286 live births, 3 stillbirths, 22 spontaneous, and 11 induced abortions.

The presentation was made here September 14^th at the 11^th Congress of the International Headache Society.

"The proportion with birth defects is 4%, not significantly different from the expected general population proportion. There was no consistent pattern among reported birth defects," Sara Ephross, of GlaxoSmithKline, wrote in an abstract.

Dr. Kori said that while the results are encouraging, he emphasised that the drug still must not intentionally be used during pregnancy at this time. Company officials say they still have insufficient data, but add they need only collect about 20 to 30 more cases to complete their data collection.

Currently, the labelling of the drug states that the safety of sumatriptan has not been established for use during pregnancy. At this time, there is no migraine drug considered absolutely safe for use during pregnancy, he added.

The issue of migraine during pregnancy is of concern whenever neurologists see women of child-bearing age. "It's a very common problem," said Maria Claricia P. Wambier, a neurologist in private practice in Ponta Grossa, Brazil, who commented on the study. "It's important to at least have something [to relieve the migraine pain]."

She said that although she is encouraged by the study, she will wait until all the data are collected, reviewed and officially approved for use during pregnancy.

GlaxoSmithKline set up the registry in 1996 to monitor outcomes of reported prenatal sumatriptan exposure. Four other studies using different methodologies have also found no increased risk of birth defects associated with sumatriptan, the abstract said.

E-Mail this DGDispatch to a colleague

To print, use this version