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

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.
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)

 

 
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