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# FDA Evaluating Need for Action on 14 Safety Signals
- URL: https://www.fdaweb.com/fda-evaluating-need-for-action-on-14-safety-signals/
- Published: 2018-01-24T12:00:00.000Z
- Updated: 2026-09-14T23:16:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140590

FDA says it is evaluating the need for regulatory action for 14 new potential signals of a serious risk found in the FDA Adverse Event Reporting System between 7/2017 and 9/2017\. A [summary](https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm592379.htm?ref=fdaweb.com) sheet identifying the signals also says that labeling was revised for Janssen’s Imbruvica (ibrutinib) capsules and Actelion’s Uptravi (selexipag) tablets, and that FDA decided that no action was needed to respond to a signal for liver injury in Janssen’s Xarelto (rivaroxaban).