Label Changes for:
Rythmol (propafenone HCl) Tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Unmasking Brugada Syndrome
- Brugada Syndrome may be unmasked after exposure to RYTHMOL. Perform an ECG after initiation of RYTHMOL and discontinue the drug if changes are suggestive of Brugada.