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

Product Name: Trade (Active Ingredient) or Product Class	Potential Signal of a Serious Risk / New Safety Information	Additional Information (as of October 25, 2023)
Corlanor (ivabradine) tablets, for oral use	Ventricular arrhythmias	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the Corlanor labeling were updated January 2017 to include ventricular arrhythmias. Corlanor labeling
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	Updated FDA decided that no action is necessary at this time based on available information.
Imlygic (talimogene laherparepvec) suspension for injection	Disseminated herpetic infection	Updated FDA decided that no further action is necessary at this time based on available information.
Kybella (deoxycholic acid) injection, for subcutaneous use	Injection-site alopecia	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the Kybella labeling were updated January 2018 to include injection-site alopecia. Kybella labeling
Proamatine (midodrine hydrochloride) tablets	Interaction with monoamine oxidase inhibitors (MAOIs) may lead to a risk of cerebrovascular accident	Updated The “Precautions/Drug Interactions” section of the Proamatine labeling was updated February 2017 to include the interaction with monoamine oxidase inhibitors (MAOIs) that may lead to a risk of cerebrovascular accident. Proamatine labeling
Sensipar (cinacalcet) tablets, for oral use	Gastrointestinal bleeding	Updated The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling Information” sections of the Sensipar labeling were updated May 2017 to include gastrointestinal bleeding. Sensipar labeling Postmarketing Requirement Under 505(o) of the Federal Food, Drug, and Cosmetic Act
Stelara (ustekinumab) injection, for subcutaneous use	Thrombotic Thrombocytopenic Purpura (TTP)	Updated FDA decided that no action is necessary at this time based on available information.
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. Gleevec labeling Sprycel labeling Tasigna labeling
Viberzi (eluxadoline) tablets, for oral use	Pancreatitis/sphincter of Oddi spasm	Updated The “Contraindications,” “Dosage and Administration,” “Warnings and Precautions,” “Adverse Reactions,” “Patient Counseling Information,” and “Medication Guide” sections of the Viberzi labeling were updated April 2017 to include pancreatitis and sphincter of Oddi spasm. Viberzi labeling Viberzi Drug Safety Communication (3/15/17)