Ongoing ARIA Assessments

CDER’s Medical Product Assessments in Sentinel’s Active Risk Identification and Analysis (ARIA) System

This page describes FDA’s active and ongoing analyses in the Sentinel System as part of the implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act, added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA uses the Sentinel System to conduct active surveillance of the safety and effectiveness of the products FDA regulates. FDA conducts safety assessments in ARIA for the following purposes, as described in Section 505(o)(3)B):

  • To assess a known serious risk related to the use of the drug
  • To assess signals of serious risk related to the use of the drug
  • To identify an unexpected serious risk when available data indicates the potential for a serious risk

The appearance of a drug on this page does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.  FDA is not suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication while an evaluation of the potential safety issue is being conducted. Patients who have questions about their use of the identified drug should contact their health care provider.

All final results will be posted in the Assessments section after the analysis is completed. Data obtained through Sentinel are intended to complement other types of data, such as adverse event reports, published study results, and clinical trials to inform regulatory decisions. Any public health actions taken by FDA regarding products involved in Sentinel analyses are communicated through existing channels.
 

  Resources

ARIA Analyses for Safety Issues Identified During Review of New Applications and Supplements

Drug Name

Outcome Assessed

ARIA Analysis Related Links 

Date Posted

Ablysinol (Dehydrated alcohol)
  • Number of percutaneous transluminal septal myocardial ablation procedures
  • Ventricular arrhythmia
  • Heart failure
  • Atrioventricular block 
  • Septal myectomy
  • Death
Level 2 10/22/2018
Annovera (segesterone acetate and ethinyl estradiol vaginal system)
  • Early detection of a large increase in the risk of non-fatal venous thromboembolism or arterial thromboembolism in the United States population
Level 3 (Sequential safety monitoring) 9/24/2018
Ilumya (tildrakizumab)
  • Lymphoma
TBD   5/25/2018
Sinuva (mometasone furoate)
  • ​Cataracts
  • Glaucoma
  • Nasal perforation
Level 1 12/18/2017
Tremfya (guselkumab)
  • Short term lymphoma e.g.,within 1-3 years
TBD   9/29/2017
Stelara (ustekinumab)
  • Serious Infection
TBD   8/23/2017
Siliq (brodalumab)
  • Neutropenia
  • Serious infections
  • Myocardial infarction and stroke
TBD   8/23/2017

 

ARIA Analyses for Safety Issues Identified Post-Approval

Drug Name                                           

Outcome Assessed

ARIA Analysis Related Links

Date Posted

Lupron (leuprolide acetate)
  • Skeletal fractures 
Level 1   9/29/2017
Gadolinium-based contrast agents
  • Seizures
Level 1,
Level 2
  8/23/2017

Ranexa (ranolazine)

  • Seizures
Level 1,
Level 2

8/23/2017