Label Changes for:

Rythmol (propafenone HCl) Tablets

March 2013

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)

 

March 2013

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.
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