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  6. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): July - September 2016 Report
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): July - September 2016 Report

Product Name: Trade (Active Ingredient) or Product Class
Potential Signal of a Serious Risk / New Safety Information
Additional Information
(as of November 3, 2016)
Corlanor (ivabradine) tablets, for oral use
Ventricular arrhythmias
FDA is evaluating the need for regulatory action.
  • Eliquis (apixaban) tablets, for oral use
  • Pradaxa (dabigatran etexilate mesylate) capsules, for oral use
  • Savaysa (edoxaban tosylate) tablets, for oral use
  • Xarelto (rivaroxaban) tablets, for oral use
Vasculitis
FDA is evaluating the need for regulatory action.
Imlygic (talimogene laherparepvec) suspension for injection
Disseminated herpetic infection
FDA is evaluating the need for regulatory action.
Kybella (deoxycholic acid) injection, for subcutaneous use
Injection-site alopecia
FDA is evaluating the need for regulatory action.
Proamatine (midodrine hydrochloride) tablets
Interaction with monoamine oxidase inhibitors (MAOIs) may lead to a risk of cerebrovascular accident
FDA is evaluating the need for regulatory action.
Sensipar (cinacalcet) tablets, for oral use
Gastrointestinal bleeding
FDA is evaluating the need for regulatory action.
Stelara (ustekinumab) injection, for subcutaneous use
Thrombotic Thrombocytopenic Purpura (TTP)
FDA is evaluating the need for regulatory action.
Tyrosine kinase inhibitors:
  • Gleevec (imatinib mesylate) tablets
  • Sprycel (dasatinib) tablets
  • Tasigna (nilotinib) capsules
Hepatitis B virus reactivation
The “Postmarketing Experience” section of the labeling for Gleevec and Sprycel and the “Additional Data from Clinical Trials” section of the labeling for Tasigna were updated to include information about Hepatitis B reactivation.
Viberzi (eluxadoline) tablets, for oral use
Pancreatitis/sphincter of Oddi spasm
FDA is evaluating the need for regulatory action.