Label Changes for:
Relpax (eletriptan hydrobromide) tablets
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
Postmarketing experience with eletriptan: Serious cardiovascular events, some resulting in death, have been reported in association with the use of Relpax.
Other Events Observed During Post-Marketing Use
- Neurological: seizure