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U.S. Department of Health and Human Services

Safety

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Rythmol (propafenone HCl) Tablets

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

 

March 2013

Summary View

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.