Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2014
Product Name: Active Ingredient (Trade) or Product Class |
Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of October 1, 2014) |
---|---|---|
Xenazine (Tetrabenazine) | Death | FDA decided that no action is necessary at this time based on available information. |
Regadenoson (Lexiscan) | Seizures, worsening or recurrence of seizures after use of aminophylline, cerebrovascular accident, and atrial fibrillation/atrial flutter | The Warnings and Precautions section of the labeling for Lexiscan was updated in September 2014 to include:
|