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

Ibsrela (tenapanor)
  • Inflammatory bowel disease
TBD 09/16/2019

Skyrizi (risankizumab)

  • Lymphoma
Level 2 08/06/2019

Invokana (canagliflozin)

  • Renal cell carcinoma
Level 2 03/04/2019
Ablysinol (dehydrated alcohol)
  • Heart failure
  • Ventricular arrhythmia
  • Atrioventricular block 
  • Septal myectomy
  • Death
Level 2 10/22/2018
Annovera (segesterone acetate and ethinyl estradiol vaginal system) Early detection of:
  • Venous thromboembolism
  • Arterial thromboembolism
Level 3 9/24/2018
Ilumya (tildrakizumab)
  • Lymphoma
Level 2   5/25/2018
Sinuva (mometasone furoate)
  • ​Cataracts
  • Glaucoma
  • Nasal perforation
Level 1 12/18/2017
Tremfya (guselkumab)
  • Lymphoma
Level 2   9/29/2017
Stelara (ustekinumab)
  • Serious infections
Level 2   8/23/2017
Siliq (brodalumab)
  • Hospitalized neutropenia
  • Serious infections
  • Myocardial infarction and stroke
Level 2   8/23/2017

 

ARIA Analyses for Safety Issues Identified Post-Approval

Drug Name                                           

Outcome Assessed

ARIA Analysis Related Links

Date Posted

Singulair (montelukast)

  • Inpatient depressive disorder
  • Outpatient depressive disorder
  • Self-harm
  • Suicide

Level 2

08/19/2019
Hydrochlorothiazide
  • Non-melanoma skin cancer
Level 2 06/11/2019
Eliquis (apixaban), Pradaxa (dabigatran), and Xarelto (rivaroxaban)
  • Severe uterine bleed
Level 2 04/18/2019

Onglyza (saxagliptin) and Januvia (sitagliptin)

  • Acute myocardial infarction
  • Heart failure
Level 2 04/01/2019
Eliquis (apixaban)
  • Gastrointestinal bleed
  • Intracranial hemorrhage
  • Stroke

Level 2

02/21/2019
Lupron Depot-PED (leuprolide acetate)
  • Osteoporotic fractures
  • Any fracture (secondary)
  • Hip replacement (secondary)
  • Temporomandibular joint replacement (secondary)

Level 2

07/02/2019
Gadolinium-based contrast agents
  • Seizures
Level 2   8/23/2017