Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Heart block [see Warnings and precautions (5.1) ] The following other adverse reactions associated with percutaneous transluminal septal myocardial ablation with the use of dehydrated alcohol, such as dehydrated alcohol injection, were identified in the literature: Ventricular tachycardia and ventricular fibrillation.
Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
5 WARNINGS AND PRECAUTIONS Transient heart block: Transient heart block is common at the time of injection.
A temporary pacing wire is routinely inserted to mitigate transient heart block.
( 5.1 ) Persistent heart block: Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker.
( 5.1 ) Remove the temporary pacemaker lead if no episode of high-degree atrioventricular block occurs.
( 5.1 ) Monitor the patient for heart failure, chest pain, and arrhythmias several days after the procedure.
Like all medications, Dehydrated Alcohol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: