Imitrex To Have Warnings In USA

Glaxo has agreed to add a warning to the labeling for its antimigraine drug Imitrex (sumatriptan) in the USA, following the death of a woman shortly after receiving an injection with the drug. The company said that it had complied with a US Food and Drug Administration request for the label revision, but stressed that neither the agency nor the company has evidence that the death was positively linked to Imitrex.

The new labeling states that deaths attributed to strokes, cerebral hemorrhage and other cerebrovascular events have also been reported in patients treated with sumatriptan. "In many cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief that the symptoms experienced were migrainous in origin when they were not," it continues. Accordingly, it is important to advise patients not to administer the drug if the headache experienced is atypical.