Label Changes for:

Relpax (eletriptan hydrobromide) tablets

July 2010

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2010

 

WARNINGS

Postmarketing experience with eletriptan: Serious cardiovascular events, some resulting in death, have been reported in association with the use of Relpax.

ADVERSE REACTIONS

Other Events Observed During Post-Marketing Use
  • Neurological: seizure
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